Biosafety Manual CRCHUSJ 2019 PDF
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2019
CHUSJ research center (CRCHUSJ)
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This document is a biosafety manual for the CHU Sainte-Justine Research Center (CRCHUSJ) in Canada from 2019. It outlines guidelines, compliance policies, and risk management procedures for working with potentially hazardous biological agents in research and educational laboratories. It's based on Canadian Biosafety Standards.
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Revision:Revision G date: April 26, 2019 Page: 1 of 82 Procedure identification: Biosafety manual - CRCHUSJ Owner: Revision approved by:...
Revision:Revision G date: April 26, 2019 Page: 1 of 82 Procedure identification: Biosafety manual - CRCHUSJ Owner: Revision approved by: CHUSJ research center (CRCHUSJ) Institutional committee for research biosafety CRCHUSJ (CIBER LES COPIES PRINTS OF THIS DOCUMENT ARE NOT CONTROLLED CHU SAINTE-JUSTINE RESEARCH CENTER Mother-child university hospital Manual biosecurity and administrative monitoring plan 1 REV. REASON FOR REVISION DATE OF PUBLICATION BY PUBLISHED A Initial publication September 2014 ABS of CRCHUSJ Revised format February 2016 ABS of CRCHUSJ C Revised format follows the Assessment rep October 2017 ABS of the CRCHUSJ of the administrative monitoring plan of PHAC Revised format April 2018 CRCHUSJABS Revised format July 2018 CRCHUSJABS Revised content, on standards and January 2019 CRCHUSJABS requirements for workers who are or may b pregnant. G Revised content, on the transport and use o April 2019 CRCHUSJ ABS GR2 agents. 2 WARNING The purpose of this document is to present a Biosafety Manual describing basic guidelines for laboratory biosafety. The information contained comes from sources deemed reliable and representative of the best recommendations. This document is intended to serve as a starting point for planning good best practices and is not intended to specify minimum legal standards. The CHU Sainte-Justine Research Center (CRCHUSJ) makes no warranty or representation as to the accuracy or completeness of the information presented in this document and assumes no responsibility in this regard. It cannot therefore be assumed that all necessary warnings and precautions are presented in this document or that any other information, measure or other additional information may not be necessary. Users of this Biosafety Manual should refer to other sources of biosafety information before performing any particular task. 1. INTRODUCTION 1.1 Aim of the full program This document includes the administrative monitoring plan as well as the CRCHUSJ biosafety manual. The monitoring plan describes the internal measures and mechanisms required to manage and control the risks associated with biosafety and biosecurity during the period of validity of the permit under the Human Pathogens and Toxins Act (HPTA). This manual also describes established local requirements and procedures based on risk and national and international good practice for working properly with potentially hazardous biological agents. These measures apply to all research activities in laboratories and in teaching laboratories where there is a possibility of exposure to these agents. The underlying rationale is based on the planning and development of safe practices aimed at preventing laboratory-acquired infections and ensuring adequate containment of biohazardous materials. This manual is based on the Canadian Biosafety Standard, Second Edition, 2015, and corresponds to best practices in the field. The handling of dangerous biological agents and recombinant DNA requires the use of certain precautionary measures. This manual provides general information and guidelines for use in basic laboratory safety procedures to ensure the containment and control of hazardous biologicals in research and educational laboratories. The transmission and implementation of these procedures during research activities are the responsibility of the principal investigator and his laboratory staff. The CRCHUSJ Biosafety Officer (ABS) or its equivalent will provide assistance by offering the advice and training necessary for the safe operations of all those involved (employees, students and the surrounding community). 1.2 Regulatory Strengths and Principles The Parliament of Canada passed the Human Pathogens and Toxins Act (HPTA). This law contains prohibitions and requirements relating to the full range of laboratory activities. The implementation of a new federal program and a new normative framework inspired by the Canadian Biosafety Standard and the Canadian Biosafety Guide were implemented in December 2015. These guides were developed by the Public Health Agency of Canada (PHAC) in collaboration with stakeholders. These guidelines form the basis of the biosecurity practices presented in this manual. Facilities handling risk group 2 or higher human pathogens must be licensed by PHAC. Under the HPTA, these standards must be followed in order to ensure the continuity of grants awarded by federal agencies. Moreover, an institutional permit is issued based on the approval of the safety manual submitted to the PHAC by the CIBER. Since 2013, some of the functions of the Canadian Food Inspection Agency (CFIA) have been transferred to PHAC. Facilities handling Risk Group 2 pathogens (pathogens affecting humans or terrestrial primates) only require a single letter of compliance from PHAC. Facilities handling exclusively animal pathogens must also comply with PHAC requirements. PHAC guidelines for laboratories: mandate the establishment of an institutional research biosafety committee (CIBER) ensuring the evaluation and monitoring of biological research; clarify roles and responsibilities in biosecurity; establish practices, procedures and conditions regulating work with biological agents. The obtaining, possession, use or transfer of any biological agent or toxin is strictly controlled by federal regulations. The importation of human pathogens is regulated by theHuman Pathogens and Toxins Regulations. Refer to the site: http://www.phac‐aspc.gc.ca/lab‐bio/permits/index‐fra.php for import permit applications. The Health of Animals Actgives the Canadian Food Inspection Agency (CFIA) (http://www.inspection.gc.ca/eng/1297964599443/1297965645317) the authority to implement the necessary controls. for handling important animal pathogens associated with notifiable animal diseases. Obtaining a permit is mandatory for anyone wishing to import pathogens into Canada. Packaging and shipping requirements for biomedical materials are governed by the Transportation of Dangerous Goods Regulations(TDGR), administered by Transport Canada (http://www.tc.gc.ca/eng/acts- regulations / laws 1992ch34.htm). 1.3 Definitions Biosecurity : Biosecurity encompasses all aspects of containment principles and technologies. Infectious agent (risk group):organism capable of producing an infection or infectious disease. Infectivity: The relative ease with which a pathogenic infection is transmitted from one host to another. Anthropopathogenic agent (risk group 2): infectious organism capable of producing disease in humans. Opportunistic microorganism (risk group 1): organism that takes advantage of a temporary decrease in the host's immune defenses to cause infection. Under normal circumstances, this organism does not cause disease. 1.4 Compliance policy and its application The CRCHUSJ must ensure to the PHAC and the CFIA the safe use of hazardous biological materials in full compliance with the standards of the PHAC and the CFIA. The ABS is responsible for the application of the compliance policy. All laboratory supervisors must ensure compliance with CRCHUSJ standard operating procedures (SOPs) by all their research personnel. Any violation of compliance is classified as a major or minor violation. These categories help determine the level of risk or danger to health and safety and provide a response that may be required when an issue of non-compliance with occupational health and safety standards is identified. A major infraction is an infraction causing an immediate risk or danger to health and safety or which may result in the release of biohazardous materials into the environment or the community. Examples of major infractions include: 1. violation of the prohibition on using or keeping food or drink or smoking in the laboratory; 2. inadequate training of new staff; 3. refusal to participate in the level 2 and above program; 4. unauthorized use or possession of biohazardous materials; 5. Inadequate or unsafe storage areas for biohazardous materials. A minor infraction is an infraction which does not cause any immediate risk or danger to health and safety or the environment. Examples of minor infractions include: 1. inadequate signage; 2. inadequate posting (eg: posting of permits); 3. Inappropriate use of biohazard labels. Measures following a major infringement: 1. First infringement: A notice will be sent to the permit holder or to the supervisor by the ABS, with a copy to the President of CIBER. Immediate correction of the violation is mandatory with a written response sent to ABS within 7 days. If the response is not received within 7 days, a second notice will be sent to the research director. If no response is received within 7 days of the second notice, a meeting will be organized with the license holder, the ABS, the Director of CRCHUSJ and the President of CIBER. 2. Second infringement: The permit holder will be informed in writing by ABS that the permission to use will be suspended until a meeting with CIBER can be held to discuss the infringements. 3. Third infringement: The ABS will recommend the cancellation of the permission to use the laboratory at fault to CIBER. Copies of this recommendation will be sent to the director of CRCHUSJ, to the laboratory supervisor and to the president of CIBER. Measures following a minor infraction: 1. First infraction: A written notice will be sent to the laboratory supervisor by the ABS, with a copy to the President of CIBER. Immediate correction of the violation is required with a written response sent to ABS within 21 days. If the response is not received within this 21-day period, a second notice will be sent, with a copy to the Director of CRCHUSJ. If no response is received within 14 days of the second notice, a meeting will be organized with the laboratory supervisor, the ABS as well as the President of CIBER. 2. Second infringement: A meeting will be organized by the ABS with the laboratory supervisor in order to examine the problems and apply the necessary corrective measures. 3. Third infraction: The laboratory supervisor will be informed, in writing, by ABS that the permit will be suspended until a meeting with the CIBER can be held. 4. Fourth infringement : The ABS will recommend to CIBER to withdraw the level of containment concerned attributed to the laboratory, which will be accompanied by a ban on the rights of possession and handling of the agents concerned for an indefinite period. Note: During the second, third and fourth infringements, copies of the notice of the measures described above will be sent to the laboratory supervisor, to the Director of CRCHUSJ as well as to the President of CIBER. CRCHUSJ ADMINISTRATIVE MONITORING PLAN Element 1: Senior management's commitment to the management and control of biosecurity and biosecurity risks within the establishment or organization. The biosafety manual / administrative monitoring plan of the CHU Sainte-Justine Research Center has been ratified by senior management. This document is accessible on the Research Centre's intranet and is highlighted in the orientation kit given to new employees, researchers and students. The Biosafety Manual describes the Biosafety Program (biosecurity is part of the program) and clearly defines the responsibilities of staff and committees involved in the management and control of biohazards and biosecurity risks. It also provides an overview of the policies and procedures of the University of Montreal with regard to the control of biosafety and biosecurity risks. Element 2: Delimitation of roles and responsibilities of committees, people, services / departments, etc., which play a role in the management and control of biosafety and biosecurity risks. 2.1 Staff and committee reporting structures: their roles and responsibilities:The biosecurity manual describes the roles and responsibilities of staff involved in the control of biological risks and biosecurity risks. As a guide, this CRCHUSJ biosecurity manual is managed and kept up to date by the biosecurity manager (also called ABS). The Biosafety Program is first and foremost a collaborative program where advice is sought from the Institutional Research Biosafety Committee (CIBER) and senior management and applied; however, where there is an imminent risk to health and safety, the manual describes the procedures in this regard. The CRCHUSJ ABS also sits on the Institutional Committee for Good Practices in Research Animals (CIBPAR) to manage and control risks in terms of biosafety and biosecurity for animal experiments. He ensures that an appropriate risk assessment is carried out and that the controlled products are controlled. 2.2 Areas of expertise of the committees:See Annex A of this document. 2.3 Nomination process and mandate of committee members:The Institutional Committee for Biosafety in Research (CIBER) of the CHUSJ has the mandate to supervise research activities to ensure the safety of personnel and that the practices and infrastructures are adequate with the HPTA requirements. The CIBPAR's mandate is to ensure that research activities using animals comply with the standards defined by the Canadian Council for the Protection of Animals (CCPA) by ensuring their well-being and always reducing the necessary number of animals as much as possible. animals in research and that everything takes place in strict ethical standards. Nomination process of CIBER members: Appointment of members according to their skills in a process of unanimity of internal members and management of the research. The mandates are valid for a period of 3 years. Nomination process for CIBPAR members: Appointment of members according to their skills in a process of unanimity of internal members and research management. There must be a CIBPAR coordinator, a veterinarian, a representative of the animal facility, 2 to 3 representatives of the researchers, 1 representative of the students as well as 1 representative of the community. There is also the presence of the institution's ABS for biosafety requirements. Mutual mandates are valid for a period of 3 years. 2.4 Scope / limits of powers: See annex 16 of the NC3 Protocol. The ABS can interrupt work due to imminent health and safety risks under the Occupational Health and Safety (OHS) legislation. 2.5 Approval Mechanism: CIBER assesses the risks of all proposed protocols and develops specific procedures and practices to perform the job safely. 2.6 Management of potential conflicts of interest (e.g.: ASB under the direction of and paid by the Vice-President of Research): The organizational structure established to optimize the compliant and safe functioning of research activities while avoiding conflict of interest situations. To this end, the ABS has no hierarchical relationship with the researchers and does not receive any remuneration from them or from any grant or funding related to research projects. Conflicts of interest could exist for research activities in CL2 or CL3 for a researcher who sits on the CIBER. In this case, the assessment requests, the risk assessments and the committee requirements will be determined by the other members of CIBER and this researcher will only be able to grant these requests. Element 3: Designation of a single contact person to provide direction to the Plan and a senior level champion who can present to senior management, on behalf of the contact person, issues related to the Plan. biosecurity. 3.1 Contact details (name, title, phone number, email address) of the person responsible for providing directives on the elements of the Plan (.: ASB) E.g The CRCHUSJ ABS is the single contact person (link) who provides guidelines and updates to the biosafety manual. The ABS reports to the Assistant Director of Administration, who makes presentations on all aspects of safety at senior management meetings and reports on them. ABS plays the role of champion on safety issues in this forum to ensure that senior management remains informed, engaged and engaged in all aspects of safety. The President of CIBER acts as a champion of biosafety during senior management meetings on all matters relating to technical aspects related to biosafety. 3.2 Contact details (name, title, phone number, email address) of the person responsible for conveying the relevant information to senior management (e.g. EHS Director) Element 4: High level overview of how the risks in subject biosecurity and biosecurity are identified in the establishment or organization. 4.1 Explanation of the way in which risks are identified in the establishment or in the organization (the mechanisms) and indication of the staff and committees concerned at the different levels: We carried out the detailed identification of the risks / dangers at the CRCHUSJ in during the writing of the biosafety manual (NCB / GCB 4.1) and, as part of this exercise, a comprehensive analysis was carried out to determine which departments and areas of the campus were handling pathogens and toxins. All activities likely to present a risk / danger have been taken into account (i.e. those related to human pathogens, animal pathogens, plant pathogens, aquatic animal pathogens, etc.) in order to that the Biosafety Program incorporate all biohazards, not just those regulated by the Public Health Agency of Canada (PHAC). This exercise is in continuity with the evaluation processes in place for the last few years, always according to the Canadian standards on biosafety. The analysis of the risk and of the agents handled is carried out using a questionnaire completed by each laboratory once a year and which can be modified in the form of an amendment (see document in Appendix E). In this document, based on the biosafety manual, we have defined in more detail the particularities of the work (i.e. risk groups,in vitro/in vivo work, etc.). The identification of these risks (assessed in element 5) is consistent with the overall risk assessment (NCB / GCB 4.1) and meets the requirements of the latter, as it was carried out at the scale of establishment. The biosecurity risk assessment (NCB / GCB 4.1) was also carried out at the facility level. These documents were submitted with all the documents in the permit application package. The initial identification of the risks / dangers allowed CRCHUSJ to develop its Biosafety Program, which is adapted to the biological work that was carried out at the time of the identification of the risks. Since then, the information has been monitored and integrated into the Biosafety Policy and the corresponding elements of the biosafety program through the internal pathogen control system (see element 5). The CRCHUSJ thus has a risk identification process according to which anyone who handles pathogens in the course of their work (e.g. researchers) is required to ensure that all risks are identified and assessed. and working practices are in place for activities involving the manipulation of infectious materials (according to the requirement for local risk assessment (NCB / GCB 4.1), (see form in Appendix B). 4.2 frequency of the risk identification process:riskTheassessment questionnaire (Annex E) is sent to the managers of each laboratory once a year. Those responsible are asked to modify the questionnaire when there is a modification or amendment to do and report it to ABS during the year 4.3 How changes or upgrades to work areas and activities are carried out (e.g. addition of in vivo work):The direction of the reserach collaborates with the material installations department to ensure that any new building or laboratory and any renovation carried out in these places (biocontainment laboratories, radiology laboratories, etc.) take into account the comments made by the security representatives. Although researchers can fund special works to redevelop their workplaces with the help of grants, it should be noted that the physical facilities department prioritizes modernization projects based on the risks arising from the gaps and ensures follow-up. in this regard through the continuous maintenance plan. 4.4 Brief description of the process used to identify research with the possibility of dual use, and specify the persons concerned: The evaluation of the questionnaire by the CIBER makes it possible to assess the risk of the agents used or modified and the results obtained and thus to determine whether dual use is possible. This decision tree is part of the risk assessment questionnaire revised annually and at each modification. This assessment concerns CIBER members (See decision tree in Annex E, taken from the PHAC guidelines, page 8). Element 5: High-level overview of how biosecurity and biosecurity risks are assessed and controlled once they have been identified by the facility or organization. 5.1 Explanation of how the risks are assessed and the approach used (must contain the process for evaluating dual-use research): The overall biohazards that were identified in item 4 were initially assessed as part of the biosafety manual. The Research Center also has a risk assessment process whereby anyone who handles pathogens in the course of their work (e.g. researchers) is required to ensure that all hazards are assessed. and that working practices are in place to mitigate the associated risks (in accordance with the local risk assessment requirement of NCB / GCB 4.1). Risk assessment and review of these assessments is also carried out as part of CIBER's activities, as needed, see form in Annex E. Site visits are also planned to validate the information described in the guidelines. documents and also inspect the premises and apply corrective measures as needed. It is the responsibility of the laboratory supervisor, in consultation with ABS and CIBER, to perform risk assessments and to require the highest level of appropriate containment available for all handling with certain specific infectious agents. Risk assessments, including the possibility of dual use, should accompany the project application forms and will be reviewed by ABS prior to approval to work with the specified pathogen. - Risk assessment form for the use of pathogens: It allows the institutional research biosafety committee (CIBER) to gather and coordinate the information associated with the types of work area, at the level of containment of pathogens , activities, on behalf of pathogens and toxins (gender for GR2 pathogens, location and responsible persons (see Annex E: Local risk assessment) and ensure the use of infrastructure and equipment adequate 5.2 Indication of staff and committees at different levels: -.Committee research biosafety Institutional(CIBER):this Committee meets four times a year meetings to discuss the biosecurity protocols submitted in the form to ensure that containment levels are properly defined and that the appropriate biosecurity practices and infrastructure are in place. t indicated in Annex A. -Institutional Committee for Good Practices in Research Animals (CIBPAR): Since ABS and some members of CIBER are part of other committees (i.e. the Committee institution of good animal practices in research, and the Administrative Council), it is possible to detect and correct biosafety or biosecurity problems even before unsafe work begins. These joint appointments also made it possible to strengthen awareness and collaboration between the work units. The ABS also has the role of approving all material transfers (MTA) within the framework of its functions in order to ensure that the biosafety aspects are covered (see form in Annex D). The active members of CIBPAR are indicated in Annex A. 5.3 The frequency of verification of the risk assessments and the persons concerned: -Internal inspection and verification program: The inspections are carried out during the assessment of the installations with the CFIA questionnaire for obtaining the facility compliance letter. The risk assessment questionnaires are revised by CIBER during the 4 annual meetings. This program allows ABS and CIBER to assess compliance with all federal, provincial, municipal and internal requirements and to continually improve the system. The results of inspections and audits can affect the status of biosecurity certification. As stated in point 1.4, ABS may interrupt work due to imminent health and safety risks under the Occupational Health and Safety (OHS) legislation. -Training program: The CRCHUSJ has an institutional training program, which clearly defines and sets out the courses that are compulsory for different groups of people. Regarding biosafety, there are basic courses that are mandatory for principal investigators and all people who handle biohazard agents, as well as more specialized training on higher levels of containment (CL2 and CL3) , precise equipment and personal protective equipment. A CL2 training for animal facility users is also given by the ABS. - Incident / accident reporting system: This is not a "control mechanism" strictly speaking, but a mechanism that facilitates the reporting of laboratory-acquired infections (LAI) to federal and provincial agencies, depending on the case. Any incident that has taken place in containment zones 2 or 3 of the CRCHUSJ must be reported to PHAC. This declaration is made by ABS on its biosafety portal in the Incident Reporting Report section. The necessary fields and information are thus filled in and sent to the PHAC. This then allows the PHAC to contact the ABS to determine and validate the procedures and management of the incident to ensure adequate follow-up. 5.4 Description of the audit trigger (s):The risk assessment questionnaire must be completed once a year. Changes to the project during the year must be sent to ABS for reassessment by CIBER. An assessment is made when there is a relocation or relocation of laboratories and practices. The ABS is still involved in the organization of these trips and requires a reassessment of the risk. Element 6: Consideration of all work areas (research, teaching, off-site work areas, etc.). 6.1 Eliminate or mitigate high biosafety and biosecurity risks to lower risk, where possible (e.g. pathogens, activities): Assessments are focused on laboratories and locations where samples are stored and / or handled, or more particularly the wet laboratories of CRCHUSJ. The risk is considered lower when no risk group 2 or 3 agent is used. All laboratory work areas are covered by the biosafety manual. Level 2 pathogen handling authorizations are issued for a containment zone, for specific principal investigators, see Appendix C of the manual for the list. Entry into containment laboratory 2 and 3 is done through a system of smart cards and biometrics. A fingerprint recognition system is thus installed for access to the level 3 laboratory. A written authorization signed by the researcher in charge and countersigned by the biosecurity officer must be completed so that users can authorize access. Copies of this form are kept by the biosecurity officer. The laboratory is also filmed by camera and the images are continuously monitored at the CHUSJ's security operations center (COS) to ensure safe and secure access. 6.2 Biosafety manual (as required by the NCB, 2nd edition, 2015), link with risk management and control: Each containment zone has its own internal biosafety procedures manual, but certain components of this manual may be the same in different work areas, as they are established for the entire establishment (overview of the biosafety program and biosecurity plans (CL2 and CL3), medical surveillance program, training program (requirements to facility scale), emergency response and incident reporting). 6.3 Internal permit or project authorization certificate system. Brief description of the application process and the information contained in the permit / certificate: See Annex F for example of an internal permit issued by ABS in connection with the NC2 permit issued by PHAC. -Agreement form between researchers and research staff : When hiring new staff, it allows the ABS to identify the needs and the nature of the material to be handled by the employee and to identify internal training necessary to follow. The employee is then contacted to ensure their participation in the appropriate training. (see Appendix B: Researcher-research staff agreement and APPENDIX 2: Use of lentiviral or adenoviral vectors). Before handling infectious agents or any material contaminated with agents belonging to risk group 3 in the containment level 3 laboratory, people must obtain authorization from the Biosafety Committee of the Research Center. This authorization is only granted after having followed the training and presenting to CIBER a letter duly signed by their supervisor attesting to their skills. A register of any transfer of biological material is kept. This register includes: the date of the transfer, the source (sender and recipient) and the quantity of biological material being transferred. A biological material transfer agreement (MTA) between the institutions and parties concerned is necessary. 6.4 Facility Biosafety Committee (CBE), if applicable. Brief description of CBE role, if not already provided in element 2: Provided in elements 2 and 5. 6.5 Off-site control mechanisms (e.g. risk management and control in remote locations) , if applicable:NA only one location. 6.6 Internal inspections / audits (e.g. process, responsible persons, frequency): Provided in element 5: - Internal inspection and verification program: Inspections are carried out during the assessment of the facilities with the questionnaire CFIA for obtaining the facility compliance letter. The risk assessment questionnaires are revised by CIBER during the 4 annual meetings. This program allows ABS and CIBER to assess compliance with all federal, provincial, municipal and internal requirements and to continually improve the system. The results of inspections and audits can affect the status of biosecurity certification. As stated in point 1.4, ABS may interrupt work due to imminent health and safety risks under the Occupational Health and Safety (OHS) legislation. Measures following a major infringement: First infringement : A notice will be sent to the permit holder or to the supervisor by the ABS, with a copy to the President of CIBER. Immediate correction of the violation is mandatory with a written response sent to ABS within 7 days. If the response is not received within 7 days, a second notice will be sent to the research director. If no response is received within 7 days of the second notice, a meeting will be organized with the license holder, the ABS, the Director of CRCHUSJ and the President of CIBER. Second infringement: The permit holder will be informed in writing by ABS that the permission to use will be suspended until a meeting with the CIBER can be held to discuss the infringements. Third infringement: The ABS will recommend the cancellation of the permission to use the laboratory at fault to CIBER. Copies of this recommendation will be sent to the director of CRCHUSJ, to the laboratory supervisor and to the president of CIBER. Measures following a minor infringement: First infringement: A written notice will be sent to the laboratory supervisor by the ABS, with a copy to the President of CIBER. Immediate correction of the violation is required with a written response sent to ABS within 21 days. If the response is not received within this 21-day period, a second notice will be sent, with a copy to the Director of CRCHUSJ. If no response is received within 14 days of the second notice, a meeting will be organized with the laboratory supervisor, the ABS as well as the President of CIBER. Second infringement: A meeting will be organized by the ABS with the laboratory supervisor in order to examine the problems and apply the necessary corrections. Third infraction: The laboratory supervisor will be informed, in writing, by ABS that the permit will be suspended until a meeting with the CIBER can be held. Fourth violation: The ABS will recommend that CIBER withdraw the concerned level of containment assigned to the laboratory, which will be accompanied by a ban on the rights of possession and handling of the agents concerned for an indefinite period. Note: During the second, third and fourth infringements, copies of the notice of the measures described above will be sent to the laboratory supervisor, to the Director of CRCHUSJ as well as to the President of CIBER. 6.7 Joint appointment to committees (if applicable): Provided in element 5: Institutional Committee for Good Practices in Research Animals (CIBPAR): Since ABS and some members of CIBER are part of other committees ( i.e. the Institutional Committee for Good Animal Practices in Research, and the Administrative Council), it is possible to detect and correct biosafety or biosecurity problems even before unsafe work begins. These joint appointments also made it possible to strengthen awareness and collaboration between the work units. The ABS also has the role of approving all material transfers (MTA) within the framework of its functions in order to ensure that the biosafety aspects are covered (see form in Annex D). The active members of CIBPAR are indicated in Annex A. 6.8 Release of research funds based on compliance (if applicable): No, research funds cannot be blocked at the outset since they are necessary for the purchasing equipment to handle agents prior to obtaining them and obtaining compliant installations beforehand. ABS approval is required for all risk group 2 or 3 agent orders, which are classified in a particular group, by receiving an automated email from the CHUSJ GRM ordering system. 6.9 Reporting of incidents and accidents: see section 9.2 of the Biosafety Manual. All incidents, whether accidental spillage, equipment failure or other, must be reported to CIBER within 24 hours. The Committee, in collaboration with the people involved, will undertake an investigation into the circumstances of the incident, will assess the risks incurred by the users and will draw up a detailed report which will be kept. All corrective measures to prevent another similar incident from occurring will be immediately communicated toallusers of containment laboratory 2 and 3. 6.10 Training program: Provided in element 5. The CRCHUSJ has an institutional training program, which clearly defines and sets out the courses that are compulsory for different groups of people. Regarding biosafety, there are basic courses that are mandatory for principal investigators and all people who handle biohazard agents, as well as more specialized training on higher levels of containment (CL2 and CL3) , precise equipment and personal protective equipment. See section 4.1.4 and 4.1.5 of the Biosafety Manual. For the CL3 training program: See section 1 of the CRCHUSJ CL3 Biosafety manual. 6.11 Management of serious and imminent risks:Provided in point 5.3. 6.12 Management and control of research with the possibility of dual use:Provided in 4.4 and 5.1. Element 7: Taking into account all those concerned (researchers, faculty, students, etc.). 7.1 List of areas where regulated activities are carried out: All laboratory work areas are covered by the biosecurity manual. Level 2 pathogen handling authorizations are assigned for a containment zone, for specific principal investigators, see Annex C of the Biosafety Manual for the full list. The Biosafety Manual takes into account all researchers, professors, clinicians, principal investigators, research technicians / technologists, graduate students and students who handle and / or store human pathogens, terrestrial animal pathogens and toxins. The handling authorizations are updated to indicate the name of the person responsible for the work area and any person who is covered by the certificate. When new researchers, principal investigators or others are hired at the CHU Sainte-Justine Research Center, a form is filled out indicating all the training courses. biosecurity requirements. 7.2 List of all off-site work areas (if applicable): N / A One location. 7.3 How each area, including off-site work areas, is taken into account by the Plan: Provided in points 4.1 and 4.2. 7.4 How information is updated when adding new work areas: Provided in point 4.3. The handling of classified agents is concentrated and confined in designated laboratories and certified as CL2 and CL3 in accordance with the requirements of the PHAC and the CFIA. A space committee deals with requests for modifications or the addition of additional spaces by researchers. This committee is made up of the Deputy Director of Administration, a responsible researcher and a technical services manager at CRCHUSJ. The ABS has a consultancy role there when necessary, if necessary installations appear to be required or required. Since the CRCHUSJ moved in December 2016-January 2017, no addition of new work areas is planned in the short term. Element 8: Communication and consultation with respect to the Plan. 8.1 The way in which all appropriate persons are entered by the system (eg: on-site or off-site): Provided in point 7.1. The Monitoring Plan and the Biosafety Manual are communicated to all concerned through various mechanisms. The CRCHUSJ uses a variety of communication tools to ensure that information is always up to date and up to date. The Research Centre's intranet is easy to navigate on the web and presents, among other things, the forms, policies (PNF), training requirements and the Biosafety Manual, including the Administrative Monitoring Plan. The members of the senior management are given reports of the minutes and the problems encountered. There are also regular meetings with senior management in which ABS participates. These meetings are also a means for senior management to relay information to ABS. Bringing together senior management is beneficial in ensuring horizontal communication between these sectors, as security issues and concerns are always cross-sectoral. The ABS interacts and communicates continuously with principal investigators, staff and students. In addition, ABS conducts ongoing consultations with CIBER to ensure consistency in communications. The ABS plays the role of intermediary between the various committees concerned. 8.2 The way in which people (old and new employees alike) are informed about the surveillance system:The administrative surveillance plan and all its mechanisms involved are addressed and applied upon hiring and during mandatory biosecurity training. In addition, the administrative monitoring plan is merged into the same document as the biosafety manual. This document is available to everyone on the CHUSJ intranet. Element 9: Monitoring and Revision of the Plan. 9.1 How the elements contained in the Plan are communicated to affected persons as well as between entities responsible for overseeing biosafety and biosecurity risks: The requirements and recommendations issued by ABS and CIBER are communicated depending on if the instructions concern an entire laboratory or a specific person. When hiring, ABS communicates directly with the people concerned by email or telephone to confirm in which laboratory (s) they will work, which agents they will handle exactly and also to ensure their registration for the appropriate training. The specific requirements and requests affecting a complete laboratory are forwarded to the designated manager of each laboratory (research assistant or associate). These communications may concern inventory requests, risk assessments, request for a letter of compliance, follow-ups of orders for agents at risk, the PNFs applied, the PPE to be used, etc. The Administrative Monitoring Plan is also available on the CHUSJ intranet, and the link is frequently disseminated and communicated to allow access to all. Email communications from CIBER and ABS are also emailed to the entire CRCHUSJ community if necessary. Element 10 Overview of Plan review and monitoring procedures 10.1 How the Plan is reviewed and monitored to improve it, increase its effectiveness or identify deficiencies:We conduct an ongoing review of the CRCHUSJ Biosafety Manual to ensure it continues to meet federal, provincial and municipal requirements. The manual is also subject to a review, which takes place annually and allows us to collect recommendations for improvement, recommendations for changes to improve efficiency and suggestions from CIBER members. and other people involved. These recommendations are collected and presented at annual CIBER meetings. If any changes are made to the regulations, the President of CIBER and ABS discuss their possible implications for the program and possible solutions for incorporating them into the program. Once this group has determined the best course of action, the solution is presented to senior management, who determines that the change needs to be made or provides other comments about the change. Any changes to the Biosafety Manual that impact on the items presented (e.g. changing roles and responsibilities of CIBER) are updated in the Plan once all of the above recommendations and approvals have been obtained. 10.2 Triggers that are used to update and communicate the Plan: ABS continually reviews incidents of non-compliance to determine trends. Depending on the sectors where cases ofnon-complianceare observed, we may make changes to biosecurity training, the certificate request process or the frequency of inspections, or even hold information sessions on specific topics. , distribute special newsletters, etc. Any changes to the program are communicated to each authorization holder and committee by email, and on the website. 2. CLASSIFICATION OF BIOLOGICAL AGENTS 2.1 Risk Groups -Canadian Standard on Biosafety(NCB),2ndEdition, page 168 Biological agents are classified into risk groups based on the relative risks they pose. The factors used to determine whether an agent belongs to a risk group are: pathogenicity, infectious dose, mode of transmission, route of infection, ability to survive in the environment, host range, availability of effective preventive measures and availability of effective treatments, natural distribution and consequences of its release in the environment or in the Canadian population. These classifications assume normal research laboratory conditions or small volume culture for diagnostic and experimental purposes. Since the classification of officers is done on a regular basis, a complete and up-to-date list should be consulted by visiting http://laws.justice.gc.ca/eng/acts/H‐5.67/. 2.1.1 Risk group 1 (GR1; low risk for the person; low for the community) Risk group 1 includes microorganisms, nucleic acids and proteins a) which do not have the capacity to cause disease in humans or animals, or b) which have the capacity to cause disease in humans or animals, but are unlikely to do so. GR1 organisms that are capable of causing disease are considered to be pathogens that pose a low risk to the health of individuals or animals, and a low risk to public health and to the animal population. GR1 pathogens can be opportunistic and threaten the health of immunocompromised individuals. Sub-assemblies of GR1 are not regulated by PHAC or CFIA due to the low risk they pose to public health and animal populations. 2.1.2 Risk group 2 (GR2; moderate risk to the person; low to the community) A GR2 agent is a pathogen or toxin that presents a moderate risk to human or animal health, and a low risk for public health and for the animal population. These pathogens can cause serious illness in humans or animals, but are unlikely to do so. There are effective prophylactic measures and treatments for diseases caused by these pathogens, and the risk of spreading these diseases is low. Examples of human GR2 pathogens are included in Appendix 2 of the HPTA. 2.1.3 Risk group 3 (GR3; high risk to the person; low to the community) Pathogens of GR3 present a high risk to human or animal health and a low risk to public health. These pathogens can cause serious illness in humans or animals. There are usually preventive measures and effective treatments for diseases caused by these agents, and the risk of spreading these diseases is low in the community. The risk of spread in the animal population varies from low to high depending on the nature of the pathogen. Appendix 3 of the HPTA provides examples of human pathogens of GR3. 2.1.4 Risk group 4 (GR4; high risk to person; high to community) Pathogens of GR4 present a high risk to human or animal health and a high risk to public health. These pathogens can cause serious illness in humans or animals and in many cases lead to death. There is generally no prophylactic measure or effective treatment for diseases caused by pathogens of GR4, and the risk of the spread of these diseases is high from a public health point of view. The risk of disease spread to the animal population, however, varies from low to high depending on the pathogen. Appendix 4 of the HPTA provides examples of human pathogens of GR4. 2.2 Pathogen Categories Agents with similar pathogenic characteristics not appearing on these lists should be considered to be in the same risk category. Since the literature can refer to many agents by various names, the supervisor should, in consultation with the ABS, verify all characteristics of an organism not on the list before determining its classification. 2.3 Toxins Toxins can include metabolites of living organisms (exotoxins) or degradation products from dead organisms (exotoxins). The degree of dangerousness associated with toxins as well as their risk group also depends on the quantity possessed. The toxins and quantities concerned can be found in the Canada Gazette of the Government of Canada http://www.gazette.gc.ca/rp‐pr/p2/2015/2015‐03‐11/html/sor‐dors44‐ fra.php # archived. Exposure to these toxins is generally limited to handling, accidental inoculation, or exposure of mucous membranes to aerosols. 2.4 Inventories Inventory registers are kept by the supervisors of the various laboratories. The CIBER will carry out the annual review of the biological material entered on the list. The inventories must include all material from a commercial, academic or private establishment, whether it is a transfer or a purchase. The supervisor will be responsible for transmitting biological material from external sources to ABS. Any new classified organism must be registered with the ABS before its introduction to the CRCHUSJ. Anyone responsible for placing an order for classified agents, viruses, bacteria or toxins must notify ABS of their request in order to ensure their approval with the CRCHUSJ purchasing department before the order can be authorized. Various orders at the CHUSJ are carried out using institutional computer software. Orders are then processed by the CHUSJ supply department. Procurement, in collaboration with the CRCHUSJ ABS, has set up a key word recognition system to identify agent orders to be approved by the ABS. The procedure to be followed is moreover described in point 4.1.3. The registration helps ABS to develop a catalog or to draw up inventories of biological hazardous materials at CRCHUSJ and the registration is used by CIBER to determine the level of biological safety (classification by risk group) of each biological agent. It also helps to ensure the safe handling of these biological materials by research teams for the protection of personnel. These inventories are used to develop the appropriate CRCHUSJ biosecurity plan. 3. Risk Assessments Risk assessment is a critical step in selecting an appropriate containment level for any work involving biohazardous materials. A detailed assessment should be performed to determine the facility's containment level requirements and operational practice requirements. For example, an organism may have a GR2 classification with CL3 safety precautions for all work with MRSA compared to work withStaphylococcus aureus. It is the responsibility of the laboratory supervisor, in consultation with ABS and CIBER, to perform risk assessments and to require the highest level of appropriate containment available for all handling with certain specific infectious agents. Risk assessments should accompany the project application forms and will be reviewed by ABS prior to approval to work with the specified pathogen. Relevant risk factors to include include: ∙ Factors associated with the host: employee's state of health, experience, attitude towards handling biological agents (e.g. a person with a weakened immune system or having a particular health condition could be more at risk). This risk increases considerably when the employee is not adequately trained or is not aware of the risks inherent in the work in progress; ∙ The environment: It is important to consider the way the agent is handled (e.g. centrifugation) or the potential for exposure to aerosols, the amount of agent used and the possible use of needles or 'other sharp objects or pipettes; ∙ Other factors: physical factors such as a crowded workplace, an increase or decrease in temperature, working hours (in the morning or late at night when you tend to be less vigilant), a student in a hurry to finish work; ∙ Biological Agent: Use PHAC's list of Pathogen Material Safety Data Sheets as a starting point (http://www.phac-aspc.gc.ca/lab- bio / res / psds-ftss / index ‐Eng.php). Information is also available on the American Biological Safety Association website (http://www.absa.org/riskgroups/index.html); ∙ The risk assessment should include information on the risk group, the potential for aerosol generation, the amount and concentration of the agent, the stability of the agent, and the type of work planned (eg. :in vitro, in vivo). A form is available on the intranet for this purpose for new pathogens and to allow an adequate risk assessment by CIBER. ∙ Vaccines: For laboratory workers, the risk associated with the biological agent can be minimized by a vaccine or other preventive measures or therapies. It is strongly recommended by the ABS, following consultations with the CHU Sainte-Justine health office, that anyone working in a level 2 containment area be up to date with their vaccinations. This service is available at the health unit at extension 4704, room B-914. 3.1 Laboratory-acquired infections A laboratory-acquired infection is described as infection resulting from laboratory work, whether a laboratory employee or any other individual who has been exposed as a result of work with an infectious agent. If disease can be shown to be due to a spill or exposure to a microorganism, then a laboratory-acquired case of infection can be proven. It is therefore necessary to document any spill, any possible exposure or any incident associated with the use of a hazardous biological material and report it to the principal investigator, to the ABS in order to ensure that all the appropriate forms are duly. completed. The toxic agents and pathogens may enter the body: ∙ by accidental inoculation (needlestick instrument infected ou glassware); ∙ through ingestion or accidental exposure to mucous membranes (poor hand washing techniques, consumption of food and drink in the containment area, suction pipetting to the mouth, splashing); ∙ by exposure to aerosols (diffusion of infected airborne particles, droplets released by forcing a liquid through a small orifice). 3. 2 Containment of Risks (BIOSECURITY - LEVELS OF CONTAINMENT) The classification of biological agents into risk groups is NOT intended to establish guidelines for the safe handling of biological agents in a laboratory setting. Therefore, certain containment levels have been established in order to provide the end user with a description of the minimum level of containment required. These containment levels describe the characteristics of the biological agent as well as the operational, technical, physical and engineering requirements for the safe handling of the latter. 3.2.1 Biosafety - containment level 1 (CL1) Containment level 1 (CL1) applies to the basic laboratory where the handling of biological agents does not require any particular design characteristics other than those which are adequate for a well functioning laboratory. designed. No biological safety cabinet (BSC) is required. The work can be done on an open bench. Containment is achieved through practices normally followed in a basic microbiology laboratory. 3.2.1.A Normal practices of CL1 laboratories The procedures to be adopted in CL1 are linked to the internal policy document PNF ‐ CELL ‐ 101.00_Salles_cultures_communes_NC1_CRCHUSJ, available on the Intranet. Access to the laboratory is limited or restricted at the discretion of the laboratory supervisor while experiments are in progress. Personnel accessing the CL1 laboratory must wear the appropriate protective equipment according to the policy described in PNF ‐ EPI‐ 400.00_Protection_Individuelle_CRCHUSJ, available on the Intranet. Work surfaces should be decontaminated at the start and end of the day and after any spillage of biological material. All contaminated liquid waste must be decontaminated before disposal. It is mandatory to wash hands after handling biological material and before leaving the laboratory. All procedures should be performed with care to minimize the creation of aerosols. 3.2.1.B Specific practices Any contaminated material that must be decontaminated in another place must be placed in a sealed, durable and closed container before removing it from the laboratory (eg: prickly or sharp objects presenting a biological hazard). Once full, this container should be placed in the biohazard material collection bins. An insect and rodent control program must be in place. 3.2.1.C Containment equipment Special equipment is not generally required for handling agents classified as CL1. 3.2.1. D Laboratory facilities The laboratory should be designed with materials that can be easily cleaned. The benches must be waterproof and resistant to acids, bases and organic solvents. Each laboratory should have a sink for washing hands. Clothes hooks should be installed near the exit for lab coats. Coats must be stored away from civilian clothing (formal attire). 3.3 Biosafety - containment level 2 (CL2) The main routes of exposure associated with organisms requiring containment level 2 are ingestion, inoculation and the mucous membrane route. Biological agents requiring CL2 installations are generally not transmitted by air, but precautions must be taken to avoid the generation of splashes or aerosols (aerosols can settle on the bench tops to present a danger of ingestion through contamination of hands and mucous membranes). The main containment devices such as BSEs, centrifuges fitted with sealed rotors or safety cups and personal protective equipment (gloves, lab coats, protective glasses) are required. Environmental contamination must be minimized through hand washing sinks and decontamination facilities (autoclaves) or through a decontamination service by an external firm. 3.3.1 Normal practices of CL2 laboratories The procedures to be adopted in CL2 are linked to the internal policy document PNF ‐ CELL ‐ 102.00_Salles_cultures_communes_NC2_CRCHUSJ, available on the Intranet. Access to the laboratory is limited or restricted to trained and authorized personnel. Personnel accessing the CL2 laboratory must wear the appropriate protective equipment according to the policy described in PNF ‐ EPI‐ 400.00_Protection_Individuelle_CRCHUSJ, available on the Intranet. Work surfaces are decontaminated at the start and end of the day and after any spillage of biological material. All infectious liquid or solid waste must be decontaminated before disposal. All persons should wash their hands after handling infectious material and before leaving the laboratory. All procedures are performed with care to minimize the creation of aerosols. All aerosol-generating procedures must be conducted inside an ESB certified to NSF 49. Lab coats must remain inside the laboratory and therefore must be coded red. Lab coats and gloves should be removed if the employee leaves the laboratory for any reason. It is forbidden to consume food or drink or to chew gum in the laboratory premises. 3.3.1.A Special practices Any contaminated material that must be decontaminated in another place must be placed in a sealed, durable and closed container before removing it from the laboratory (eg: sharp or prickly objects presenting a biological hazard). Access to the laboratory is controlled and limited by the principal investigator or by the laboratory supervisor. In general, anyone at increased risk of acquiring an infection should not enter the laboratory. The principal investigator or laboratory supervisor is responsible for assessing all of the circumstances and determining who may enter or work in the laboratory. If the use of one or more infectious agents requires special conditions (eg vaccination), a biohazard warning sign must be posted on the access door to the laboratory area. This warning must identify the name of the infectious agent (s), the name principal investigator (s) and / or any other responsible person and indicate the specific requirements for access to the laboratory. An insect and rodent control program must be in place. Special precautions are necessary to prevent any contamination of the skin by infectious material; gloves must be worn when skin contact with infectious material is possible. All laboratory waste must be identified by an appropriate label and decontaminated before disposal. The use of needles and syringes is strictly reserved for injecting and aspirating liquids into diaphragm vials. Any accident or spill leading to obvious exposure to infectious material should be reported immediately to the principal investigator and ABS. Any infectious agent should be stored inside a clearly identified leak-proof container. 3.3. Containment equipment biological safety cabinets (BSE) in class I or II should be used: For highly likely to generate infectious aerosols procedures, including centrifugation, mixing, stirring or mixing energy, disaggregation ultrasound and opening of containers of infectious material; For procedures involving high concentrations or large volumes of infectious agents. These materials must be centrifuged and opened inside an ESB. The air from these BSEs can only be recycled into the laboratory after passing through a high efficiency particulate air filter (HEPA). This type of BSE includes types A to B3, most of the BSE of CRCHUSJ being Class II Type A2. 4. RISK CONTROLS Among the methods used to control risks are: ∙ administrative controls; ∙ engineering controls; ∙ personal protective equipment (PPE); ∙ medical surveillance; ∙ the design of the installations. PHAC and CFIA containment levels may not match the risk group of a given organism, as the complete risk assessment (biological agent used, host and working environment) may demonstrate the need for manipulate this organism in a more controlled environment. 4.1 Administrative controls 4.1.1 Register of biohazardous materials Anyone wishing to work with biohazardous materials must complete a request form for the use of biohazardous material available on the intranet and submit it to the biological safety officer. This request is being reviewed by CIBER to determine if it meets PHAC biosafety standards. CIBER will carry out a local risk assessment for the biological agent in question. If necessary, certain recommendations are offered to the applicant. 4.1.2 Standard Operating Procedures (SOP) A SOP must include a work analysis. The hazardous biological materials used as well as the written procedures must be included on the application form submitted to CIBER. Any deviation from procedure must be specified. PNFs specific to each pathogen must be associated with all general PNFs for the work area concerned (wet or dry laboratory, cell culture laboratory, etc.) and at the level of containment concerned, all available on the Intranet. 4.1.3 Importation, Transfer and Transportation Importation of Biological Hazardous Materials Human Pathogens: The Public Health Agency of Canada (PHAC) is the regulatory body for human pathogens. ∙ Step 1 - Consult the ABS on the agent to import. ∙ Step 2 - Fill out the biohazard material use form (if necessary) duly completed at the CRCHUSJ ABS for approval. ∙ At CRCHUSJ, biological agents are normally obtained from a company distribution systems such as ATCC, Cedarlane or Sigma ‐ Aldrich. No import permit application is therefore required. In this case, the company requires the current PHAC permit number before delivering the goods. ∙ When ordering organic agents, send a copy to ABS, as the purchasing department needs ABS approval before completing the order. Transfer A record of any transfer of biological material should be kept. This register includes: the date of the transfer, the source (sender and recipient) and the quantity of biological material being transferred. A biological material transfer agreement (MTA) between the institutions and parties concerned is necessary. Transport Ensure that biological material is stored in a sealed container placed in a second sealed container for transport between laboratories. Product packaging shall be approved by ABS having received the appropriate training. The transport of biohazardous materials within Canada is governed bythe Transportation of Dangerous Goods Regulations(TDG-DORS / 85-77). It is prohibited to ship dangerous goods through Canada Post. 4.1.4 Training When a new employee joins a laboratory, this employee must follow orientations and training in biosafety in connection with the activities planned in his program. The necessary training is determined during the hiring of the newcomer and his internal agreement between the researcher and the staff member. This is not only good laboratory practice, but is also part of the Human Pathogens and Toxins Regulations. An employee must complete the biosafety guidelines related to his facilities as well as his laboratory space. This employee must be adequately trained before performing any inherent risk task or procedure. In addition, it is necessary to document and keep a register of all orientations or training courses taken in matters of biosafety. Training materials are also needed to meet biosafety requirements. This information is stored and available for consultation in the CRCHUSJ database. 4.1.5 CFIA and PHAC Biosecurity training is mandatory for all new principal investigators, supervisors, research staff, monitors and students who work with microorganisms, with cell culture, with blood and with human body fluids. The ABS is responsible for ensuring the training of new employees appropriate to the particular materials and / or biological processes of the laboratory. This training must be provided before the start of any work and documented by ABS. Following his biosafety training, the participant will: demonstrate a good understanding of the risk assessment procedure related to his work with microorganisms and cell lines; demonstrate a good understanding of the concept of containment levels as it applies to biohazard laboratories; describe the functionality of a BSE and its role in a biohazard laboratory; describe the procedures to be followed in the event of accidental exposure or spills of biohazardous materials; describe the risks associated with human blood and body fluids; demonstrate how to take precautions when working with human blood and body fluids. Among the items that should be included in a training document are: o The name of the research supervisor; o the name of the trainee and his signature; o the name of the instructor; o the date of the end of the training. Biosafety training offered at CRCHUSJ must include: ∙ theoretical information from PHAC courses (on CL2 laboratory operational practices, among others, depending on the project); ∙ orientation on the CL2 zone at CRCHUSJ, on fundamental biosafety, on biological safety cabinets, on autoclaves and on spill procedures at CRCHUSJ (offered by ABS); ∙ specific training on the procedures used in the context of the project (offered by the principal investigator); ∙ The form read and understood duly completed by the student and the supervisor (see forms). 4.2 Medical surveillance / vaccinations Individuals who work with infectious material are at risk of developing a laboratory acquired infection (LAI). ∙ All students, working in any area, including field soil sampling or laboratory projects, are strongly advised to keep their immunizations up to date, including tetanus (every 10 years). Refer to the guide: http://www.cdc.gov/vaccines/schedules/index.html. ∙ Please contact the CHU Sainte-Justine health office for any medical questions or if you have any underlying pathological condition that may require medical surveillance. ∙ The new worker registration form links with the health unit for immunization follow-up (see Appendix B) 5. GENERAL SAFETY MEASURES AND PROCEDURES 5.1 Basic laboratory safety practices Employees must be informed of possible biological risks before entering the work area. Laboratory doors should be kept closed. Wearing PPE according to PNF ‐ EPI ‐ 400.00_Protection_Individuelle_CRCHUSJ is mandatory in any designated area of the laboratory if the work may cause the production of splashes or generate aerosols and involving contact with bodily fluids, products (solvents and powders) chemical, with infectious materials or with infectious animals. Any contaminated clothing must be disinfected by an appropriate means. Wearing all the personal protective equipment mentioned in PNF ‐ EPI ‐ 400.00 is strictly prohibited in rest, office and dining areas as well as in public places of the CHUSJ (cafeteria, atrium, amphitheatres and meeting rooms , pharmacy, clinics, etc…). Suction pipetting by mouth is prohibited. Consumption of food or drink, smoking of cigarettes or chewing gum is prohibited in laboratory areas. The laboratory must be kept clean and free of materials not relevant to the work. Work surfaces should be decontaminated at least once a day and after any spill. Employees should wash their hands after handling any infectious material and before leaving the laboratory. Any spills, accidents or possible exposure to infectious material should be reported immediately to the Principal Investigator and ABS. ABS should ensure that appropriate biosafety training is provided with respect to infectious materials. All procedures should be performed with care to minimize the creation of aerosols. Any contaminated or infectious solid or liquid must be decontaminated before disposal or reuse. When infectious agents are used in the laboratory, a biohazard warning sign with the universal biohazard symbol must be displayed on the door giving access to the work area. 5.2 Culture of bacteria in laboratory media For microbiological research purposes, it is essential to learn the knowledge necessary to perform inoculation of specimens in culture medium. For example: always use aseptic technique; clean the bench using the disinfectant supplied before starting work and at the end of work; ensure that the handles and inoculation needles are sterilized by buckling at the end of the work to avoid any formation of aerosols; Dispose of all biohazardous waste in the appropriate area. 5.3 Work with laboratory animals By definition, any work involving an animal is considered to be work involving a biological risk. Animals can harbor infectious organisms that can be transmitted to humans. Laboratory facilities should ensure a level of containment of laboratory animals exposed to infectious agents (or harboring infectious agents) appropriate to the level of risk presented by the infectious agents involved. Animal care requirements can vary in scope and degree. However, the basic principles of microbiological safety will be similar to those described in section 3 and they should include the following precautions: 1. Infected animals should be isolated from uninfected animals in the appropriate containment areas of the animal facility. It is preferable to isolate any handling area from the containment or transition area; 2. Any animal used for research must be maintained at a level of containment at least equivalent to the level of containment of the biological agent with which it has been infected or treated; 3. Measures must be taken to prevent any escape of inoculated animals; 4. Any dead animal and any waste from the animal facility and cages (eg: bedding, excrement and food) must be placed in a biohazard waste bag, then prepared for decontamination; 5. All cages must be properly identified. All procedures followed in the holding or transition area must minimize the dispersion of dander and dust from animals and cage waste; In addition to the above: 6. All aspects of the proposed use of animals in research must comply with the standards and regulations of the Canadian Council on the Care of Animals in Science (CCAC) and the Animals for Research Act. Any work involving animals requires the prior approval of the Institutional Committee for Good Animal Research Practices (CIBPAR); 7. The appropriate species should be selected for animal experiments following the 3R rule; 8. The researcher and / or those in charge of an animal experiment must ensure that any person coming into contact with the animals and the waste must have received the appropriate local training and are therefore familiar with the special precautions and procedures that may be required. If possible and justified, personnel should be protected by immunization with appropriate vaccines; 9. Any incident, including an animal bite or scratch or a cut caused by an angle / sharp edge of a cage or other equipment must be documented and reported by the employee to ABS and the supervisor. of the laboratory. 10. Users must comply with the specific animal house policy POL213‐00, Housing and care of rodents containment level 2. 5.4 Working with human infectious agents Certain microorganisms (viruses, bacteria, fungi, etc.) are specific to a given species, infecting and causing disease in one or a limited number of host species. Unrelated species and distant species may not be affected in the same way by the same infectious microorganism due to physiological, metabolic, biochemical, etc. differences. In general, the risk to laboratory personnel working with a virus that infects and causes disease in rodents is lower than the risk to laboratory personnel working with tissues and cells from humans or other primates. If the human material contains a viable pathogen, it will likely be an anthropopathogen (human pathogen) with the potential to infect and cause disease in another human. Infectious agents and pathogens classified as Risk Group 2 (GR2) by PHAC (see ePathogen portal for classification: https://health.canada.ca/en/epathogen) must be handled according to Containment Level 2 standards ( NC2) and in properly certified rooms. The safety of personnel must be ensured by wearing PPE, using BSE and using airtight containers. The transport of GR2 agents from a certified room to rooms not certified for the use of devices or for storage and handling must be carried out in sealed containers and closed with a screw cap or securely attached to the container (i.e. centrifuges). While only one route of transmission may be predominant, pathogenic microorganisms can be spread or transmitted, directly or indirectly, from host to host by a number of means, including the generation and inhalation of aerosols. , ingestion of contaminated food and water, contact of the skin and mucous membranes with contaminated surfaces, contact contamination of an open wound or lesion, and self-inoculation by a cut, laceration or puncture caused by a contaminated instrument. 5.5 Human borne blood-pathogens Human blood is recognized as a possible source of pathogenic microorganisms that may present a risk to workers exposed during the performance of their tasks. Although hepatitis B virus (HBV) and human immunodeficiency virus (HIV) are often cited as examples, a blood-borne pathogen is understood to mean any pathogenic microorganism present in human blood or any potentially infectious material that can infect and cause disease in people exposed to blood or other potentially infectious material that contains this pathogen. By "other potentially infectious material" means any material having the potential to transmit blood-borne pathogens. All infected human tissue and the following bodily fluids are included: semen, vaginal fluids, cerebrospinal fluid, synovial fluid, pleural fluid, peritoneal fluid, pericardial fluid, amniotic fluid, saliva in procedures, dental and other bodily fluids visibly contaminated with blood. 5.5.1 Universal Blood and Body Fluid Precautions The possibility of an undiagnosed infection combined with the increasing prevalence of HBV and HIV infection has led the Centers for Disease Control (CDC) to recommend that the blood and various other bodily fluids of all humans are considered potentially infectious and that certain precautions be taken to minimize the risk of exposure. This approach, called “universal precautions”, is a method of infection control designed to prevent parenteral exposure and exposure of workers' mucous membranes and non-intact skin to blood-borne pathogens. Hepatitis B virus (HBV), human immunodeficiency virus (HIV) and other blood-borne pathogens are considered to be potentially transmissible through human blood, certain human body fluids and through other materials. Precautions must be taken systematically. Universal Precautions apply to certain body fluids including blood, body fluids containing visible blood, semen, vaginal fluids, cerebrospinal fluid, synovial fluid, pleural fluid, peritoneal fluid, pericardial fluid, and amniotic liquid. Universal Precautions do not generally apply to feces, breast milk, nasal secretions, sputum, saliva, sweat, tears, urine or vomit, unless they contain visible blood. Although these materials are not involved in the transmission of blood-borne pathogens, it is nevertheless prudent to minimize contact of these materials with non-intact skin and with mucous membranes. HBV immunization, in conjunction with Universal Precautions, is recommended for employees exposed to human blood or other potentially infectious material in the course of their duties. HBV vaccination is offered free of charge to employees at risk. 5.5.2 General Occupational Safety Precautions 1. All employees should take precautions through systematic use of appropriate barrier measures to prevent exposure of skin and mucous membranes when contact with human blood or with other bodily fluids is expected. 2. Eating, drinking, smoking, applying make-up, using lip balm, and putting on or taking off contact lenses are prohibited in the laboratory. 3. Wear gloves when in contact with blood, body fluids, mucous membranes or non-intact skin and when handling material. surfaces or articles soiled with blood or body fluids and when performing venipunctures or other procedures requiring a vascular access route. If a glove becomes torn or damaged during use, it should be removed and replaced as soon as safety considerations permit. It is prohibited to wash or disinfect disposable (single-use) gloves for reuse. Washing gloves with surfactants can increase permeability, allowing liquids to penetrate through undetected glove holes. The use of disinfectants can cause deterioration of the glove material. 4. The wearing of protective glasses or a face shield is mandatory during any procedure that may generate droplets of blood or other body fluids in order to prevent exposure of the mucous membranes of the mouth, nose and eyes. 5. The wearing of a long-sleeved, fully buttoned lab coat or apron is mandatory during any procedure that may generate droplets of blood or other bodily fluids. Remove protective clothing before leaving laboratory areas. 6. Wash hands and other skin areas thoroughly immediately after possible contamination with blood or other bodily fluids. Wash hands immediately after removing gloves, as no barrier is 100% effective. 7. Employees should take precautions to avoid injury from a needle, scalpel or other instrument or sharp device during or following any procedure, when cleaning a instrument used, when disposing of a used needle and when handling a sharp instrument. Needles and syringes should only be used if there is no other solution. To prevent needle stick injuries, needles should not be recapped, bent or broken by hand expressly or removed from disposable syringes or otherwise handled by hand. After use, disposable syringes and needles, scalpel blades and other sharp objects should be placed in a puncture-resistant container for disposal immediately after use. This puncture resistant container should, as far as possible, be located as close to the work area, including in BSEs. 8. Any employee who has suffered an exudative lesion, oozing eczema, skin lesion, open wound, or other skin lesion should avoid direct contact with blood or other bodily fluids until the condition is resolved or should use protective barriers to reduce the risk of exposure. 9. All pregnant employees must in particular know and scrupulously observe the precautions to minimize the risk of perinatal transmission of blood-borne pathogens. The application of a preventive withdrawal from related activities may be considered and carried out according to the recommendations and requirements of the employer and / or the attending physician. 5.6 Working with antineoplastic agents, chemotherapy or agents categorized as teratogenic or carcinogenic in WHMIS. Handling with any antineoplastic agent, chemotherapy or agents categorized as teratogenic or carcinogenic in WHMIS must be carried out in accordance with NIOSH requirements (ref). The handling of these products is prohibited for any employee who is or may be pregnant. The disclosure of this information remains confidential between the superior and the Research Department. The application of a preventive withdrawal from related activities may be considered and carried out according to the recommendations and requirements of the employer and / or the attending physician. 5.6 Biohazard Warning Signs and Labels warning signs The Public Health Agency of Canada requires that and / or symbols be used to inform staff and visitors of potential workplace hazards. More particularly, in relation to biological risks, the universal symbol of biological risk must be used to "signify the actual or potential presence of biological risks and to identify the equipment, containers, premises, materials, laboratory animals or any combination thereof. , containing and / or being contaminated with viable biological agents ”. 1. The CRCHUSJ requires that the universal symbol of biological risk be used to designate the presence of substances or agents considered to be of biological risk. 2. An appropriate biohazard sign should be prominently displayed in every laboratory and work area where biohazardous substances are used and / or stored. If infectious agents are used, a biohazard sign must be posted in front of the laboratory door indicating the nature of the risk, the level of biological risk, the specific measures to be taken before entering the laboratory and contact details. the principal investigator and / or any other responsible. 3. The principal investigator or supervisors are responsible for ensuring that all biohazard signs are accurate and up to date. Inform ABS of any necessary changes in signage and / or labeling of equipment. 5.7 Access / Security Controls Doors should be locked when laboratories are unoccupied. Only authorized persons can enter the laboratory areas. Children under the age of 14 should absolutely not enter wet laboratory work areas. 5.8 Cell culture Any new NC2 cell line introduced into CRCHUSJ must be registered with ABS. The preservation and recovery of frozen cell cultures from liquid nitrogen requires personal protective equipment. There are three major risks associated with liquid nitrogen (-196 ° C): frostbite, asphyxiation and exposure. Wear cryogenic gloves thick enough to provide insulation, but flexible enough to allow handling of the ampoules. When immersing an ampoule in liquid nitrogen, a high pressure differential between the outside and the inside of the ampoule results. If the ampoule is not fully sealed, the pressure differential can lead to inhalation of liquid nitrogen, which may cause the ampoule to explode violently during thaw. Wearing protective glasses, a face shield is required. ESBs must be kept clean and free of unnecessary equipment or materials to ensure their proper functioning. Liquid waste must be decontaminated using chemical disinfectants (eg: 1:10 sodium hypochlorite solution). Vacuum liquid waste collection bottles should be kept in a secure location and should contain an appropriate disinfectant. Collection bottles should also be fitted with a non-return valve to protect the central vacuum system. Transfers must be made to minimize splashing. All vials should be properly labeled. Decontamination of BSE should be carried out using the disinfectant provided, liberally sprayed on the surfaces, followed by wiping the surfaces with an appropriate disinfectant, usually a 70% ethanol solution, at the end of the procedure. Solid waste should be placed in biohazardous waste bags and the biohazardous waste should be well sealed for autoclaving. Biological hazardous waste bins with lids should be used as the primary means of disposing of solid waste. Glass pipettes should be placed in used pipette containers with an appropriate disinfectant. Disposable plastic pipettes should be disposed of in appropriate containers and placed in the biological waste bins. Sharps should be put in the yellow sharps containers for biohazardous sharps or sharps. 5.9 Personal protective equipment (PPE)relating The requirements to the wearing of PPE are described in the PNF ‐ EPI‐ 400.00_Protection_Individuelle_CRCHUSJ policy, available on the Intranet. The selection of the type and amount of clothing and equipment to be used in a given procedure is made on the basis of the research and associated risk levels. Wearing, at a minimum, a lab coat, closed shoes and gloves is compulsory in all microbiology laboratories. Laboratory coats, gloves and closed shoes help prevent any contact of biohazardous material with the skin and surfaces where a cut, scratch or dermatitis may occur. Exposed legs are vulnerable to risks. It is therefore inappropriate to wear a skirt or short pants. Closed-toe shoes help protect the feet from spills and injury from sharp falling objects. Wear non-slip soles to prevent slipping or falling. It is also forbidden to wear any component of the PPE outside the CRCHUSJ laboratory areas. 5.9.1 Laboratory coats Laboratory coats protect civilian clothing from contamination and prevent any possible cross-contamination by normal skin flora. They are available at the CHUSJ cleaning service. Wearing the official CHUSJ laboratory coats is compulsory for all staff, including visitors, trainees and other people who work or enter the laboratory. Coats must be properly buttoned. The CHUSJ coats are also classified by color code according to their use: Code blue: interaction with patients, care units, clinics Code Rouge: laboratory coat, for diagnostic or research laboratories. Green code: transfer lab coat, for movement between laboratory areas Beige smock coat: for visitors and technical services Thus, CRCHUSJ staff can make up three (3) categories of lab coats. The blue coded coats can be worn by personnel involved in clinical research involving patients clinics. The coats coded red must be strictly worn in the laboratories of CL1 and CL2. They should remain there until they are to be taken to the laundry room when not in use. Each user must have his lab coat designated and identified. Thus, the sharing of coats is prohibited. The coats coded green are used to move personnel between laboratory areas, in corridors, service elevators, secondary support rooms (reserves, autoclaves, cold rooms, freezer rooms). Beige coats are used by technical personnel entering a laboratory area. Each laboratory must have at its disposal at least two (2) beige visitor coats. If contaminated, lab coats should be autoclaved before bringing them to the laundry room. If decontamination is not possible, the lab coat should be disposed of in the biohazard waste bin. Laboratory coats should be stored in a separate area, separate from civilian clothing. 5.9.2 Gloves The wearing of suitable gloves is mandatory for all procedures which may involve direct or accidental contact with biohazardous material. Latex or vinyl gloves offer a high level of dexterity as well as an increased level of sensitivity; however, they do not offer much protection against needle punctures, animal bites or sharp objects. All gloves eventually become permeable and should be changed periodically. In case of contamination or breakage, remove gloves immediately and wash hands with soap. Some procedures may require you to wear two pairs of gloves on top of each other. If two overlapping pairs of gloves are worn, fold the folds of each glove over the lower cuffs and sleeves of the lab coat. Gloves should be removed before leaving the laboratory and decontaminated with other laboratory waste prior to disposal. The table below shows the preferred protective gloves against various products. BENEFITS TYPEESAVANTAGES USE WIT latex low cost∙ dexterity ∙ low resistance to oils, bases, acids, alcohols, dilute rubber goodproperties greases, organic solvents a aqueous solutions ∙ fairly good natural physical ethidium bromide ∙ may resistance to aldehydes and cause allergic reaction. ketones blends low cost∙ dexterity ∙supe physical properties bases, acids, alcohols, dilute rubber resistance often inferior to aqueous solutions ∙ fairly good natural generallyto chemicals natural rubber ∙ resistance to aldehydes and may cause an allergic ketones reaction. chloride low cost ∙ very good Plasticizers may be release bases, acids, salts, aqueous polyvinyl physical properties ∙ solutions, alcohols, oils, (PVC) moderate resistance to fats and petroleum products chemicals neoprene medium cost ∙ medium low resistance , oxidizing acids, alcohols, anilin resistance to chemicals ∙ tohydrocarbons phenols, glycol ethers, solvents, medium physical propert chlorinated oils andproducts ∙ high resistance to moderately corrosive breakage and heat nitrile low cost∙ dexterity ∙ low resistance to oils, greases, xylene, excellent physical chlorinated organic solven aliphatic hydrocarbons, properties perchlorethylene, trichloroethane, ethidium bromide ∙ fairly good resistance withtoluene butyl Good resistance to high price ∙ offers glycol ethers, ketones, esters, organic solvents with low resistance to aldehydes,solvents polarity, high resistance t hydrocarbons and organicwithpolarity gas andvapor chlorinated solvents water alcohol resistance to a very high cost ∙ water hydrocarbon polyvinyl wide range of sensitive ∙ low resistance to aliphatic and (APV) organic products ues ∙ bases, acidsand aromaticsolvents, goodproperties alcoholslight chlorinated ketones (except physical acetone), esters, ethers good resistance to extremely high cost ∙ poor aliphatic and aromatic fluoroelastomer organic and aromatic physical properties ∙ low hydrocarbons, chlorinated (Viton®) solvents ∙ flexible resistance to some esters, solvents, oils, lubricants,acids ketones and amines mineral, alcohols Norfoil, Silver Excellent harsh∙ low hazardous materials ∙ good Shield®, 4H® resistance to adhesion ∙ poorly resistance to solvents, acids and adapted to the size of bases chemicals the hand ∙ easily punctured 6. PREGNANT bIOLOGICAL sAFETY (BSE) In the context of any biological safety program, protection of the respiratory system is a major concern, as infectious organisms can easily penetrate in the human body through the respiratory tract. Engineering controls (biological safety cabinets or BSEs) are the primary barrier against inhalation of biohazardous materials and should be used whenever possible. Respirators should only be used as a secondary control measure. An ESB is a ventilated enclosure that operates using a high efficiency filter for air particles, laminar air flow, and containment measures to protect personnel, the environment and the product from microparticles. or aerosols associated with biohazardous materials. An ESB differs from a chemical hood by the presence of a high efficiency filter for air particles and by the laminar nature of the air flow. A brief description of the ESB classes, their functionality and the limitations of each class is presented below. 6.1 Class I biological safety cabinet This is a ventilated enclosure which partially protects the employee (operator) and the environment, but which does not protect the product in any way. There is no air recirculation in a Class I ESB. The air is drawn out of the operator's area and, after being filtered by a HEPA filter, directed to the outlet exhaust line. outside. Carcinogenic chemicals, low dispersion radioactive materials and volatile solvents can be used in a Class I BSE. 6.2 Class II Biosafety Cabinet This is a ventilated enclosure that protects the handler, the environment and the product. In a Class II BSE, there is a flow of sterilized air (having passed through a HEPA filter) to the interior of the enclosure. The exhaust air must also pass through a HEPA filter. The use of a Class II BSE is necessary during procedures that may generate potentially infectious droplets or aerosols. Procedures that can create aerosols include: grinding, mixing, agitation or energy mixing, and opening containers of infectious material at pressure below or above ambient pressure. Laboratory "open air" centrifugation can only be performed if the sample tubes or vials are airtight and sealed with caps or if the centrifuge is fitted with safety cups with tight lids. In addition, the opening of leak proof cups or sealed tubes should always be done in the ESB. The most commonly used BSEs at CRCHUSJ are class II BSEs. These enclosures protect the operator, the environment and the product (see Figure 3). Only ESBs with rigid exhaust ducts leading to the outside and providing a face velocity of 80 to 125 feet per minute should be used for handling substances. volatile chemicals. Note: These enclosures are not intended to prevent the ignition of volatile flammable chemicals. 6.3 Work in a biological safety(BSE) cabinet The institutional policies of the CRCHUSJ in terms of good working practices with BSE are described in the procedure PNF ‐ CELL‐ 101.00_Salles_cultures_communes_NC1_CRCHUSJ, available on the Intranet. Turn on the fluorescent lights and the fan at least 10 to 15 minutes before use if the BSE is not always on; Disinfect the work surface using an appropriate disinfectant, then 70% alcohol; Provide the necessary materials for the work to be done in the BSE; Place all the necessary materials on an absorbent pad in order to absorb the aerosols generated; Place items in the ESB so that they can be used effectively without disturbing the air flow. Work with the materials proceeding from the clean side to the dirty side; Wear appropriate personal protective equipment, ie, at a minimum, a buttoned lab coat and gloves; Wait about one minute after inserting the hands / arms into the enclosure before handling the materials; Minimize movement of the hands to and from the BSE as much as possible; If it is necessary to exit the BSE, slowly and horizontally remove the hands from the BSE. Allow the airflow disturbance to decrease before putting your hands back into the BSE. Never cover the ventilation grids with any material so as not to disturb the air flow. Work at a moderate pace so as not to disturb the air flow with sudden movements. Wipe the bottom and side of the hood surfaces with a disinfectant after finishing work. Let the hood operate for a few minutes after completing the procedures before turning off the fan. 6.4 BSE Certification Certification of all BSEs is required during installation, when filters are changed, before or after any relocation or transfer, and annually. BSE decontamination is necessary prior to any travel. The ABS must approve all changes to the ESBs. BSE certification is required after any modification. The ABS must make the necessary arrangements with regard to the certification program, in concert with the material installations department of the CHU Sainte-Justine. The certification of each ESB is confirmed by the presence of a sticker from the certification firm with the date carried out and the date of the next certification. In case of problems with the operation of an ESB, it should be stopped using it; contact ABS immediately. 7. SAFETY INSTRUCTIONS FOR LABORATORY EQUIPMENT 7.1 Sonicators When used with infectious agents, sonicators can release large amounts of hazardous aerosols. Sonicators should operate, as much as possible, inside a BSE. Sonicators are devices typically used for cell disruption and for mixing samples. Vortex shakers are also used for sample mixing. Observe the following safety precautions when using sonicators to reduce the risk of aerosol generation. Safety guidelines include the following procedures: Loosely close each sample bottle or tube with a cap; Make sure there is enough water in the sonicator; Avoid prolonged sonication; Check all glassware to be used in the sonicator. Do not use chipped or cracked glassware; Systematically replace the sonicator liquid; Avoid sonication of volatile compounds; Whenever possible, use secondary containment (container inside a container inside the sonicator); Perform sonication in a room and in an isolated area; Make sure to wear adequate hearing protection; Let the aerosols fall for at least one minute before opening the containers. 7.2 Centrifuges The safe use of centrifuges requires proper maintenance and operation. Failure of mechanical parts or malfunction can cause the generation of projectiles, hazardous chemicals and biohazardous aerosols. Repair and maintenance must be carried out by qualified and adequately trained personnel, such as company representatives or the CHUSJ biomedical engineering department. Centrifuges are a potential source of biological and chemical contamination due to their fast speeds and relatively high pressures. The following safety precautions should be followed when using centrifuges: The centrifuge should be clean before starting. Do not operate it if material spills into the frame or the rotor; Make sure that the interlocking device prevents the opening of the lid when the rotor is running and that the centrifuge cannot be set in motion when the lid is open; Make sure the centrifuge is level. If this is a portable model, make sure the centrifuge is securely secured on the lab bench before starting; Check all the equipment to be centrifuged. Make sure there are no cracks or structural weaknesses. Ensure that the material of the tube provides the necessary chemical resistance and allows the range of required rotational speeds to be covered; Use the lowest speed and duration settings to get the job done; Make sure that the tubes and plastics used are compatible with the chemical reagents and solvents used. Make sure that the tubes and plastics used are certified and compatible with the rotor and the necessary speeds. Avoid overfilling the tubes; Make sure that all the loads are balanced using an adequate scale; Do not open the lid until the centrifuge rotor has come to a complete stop; In the event of a spill, disinfect immediately and allow it to dry completely before proceeding to the next centrifugation; Examine the centrifuge periodically. Check the seal of the cover, the baskets, the rotors and, if necessary, lubricate the anchors of the fixed buckets; Avoid using volatile materials whenever possible; Whenever possible,