MP-040.06 CLEANING OF THE CEF LABORATORY AT BUILDING 8901.pdf

Ceva Animal Health, LLC STANDARD OPERATING PROCEDURE MP-040.06 Author: Chris Guerrero APPROVAL DATE:...

Ceva Animal Health, LLC STANDARD OPERATING PROCEDURE MP-040.06 Author: Chris Guerrero APPROVAL DATE: CLEANING OF THE CEF LABORATORY 14 Jul 2021 AT BUILDING 8901 EFFECTIVE DATE: 16 Jul 2021 Page 1 of 6 1. PURPOSE & SCOPE The purpose of this SOP is to establish the procedure for daily cleaning of the CEF laboratories before and after a procedure is performed. 2. ROLES & RESPONSIBILITIES Managers, supervisors, and team leads are responsible for training of their respective staff and ensuring compliance with this SOP. OFFICIAL QUALITY DOCUMENTATION All technicians are responsible for adhering to all of the procedures and safety guidelines listed in this SOP. 3. HEALTH, SAFETY & ENVIRONMENT Safety glasses must be worn as detailed in SOP HS-001, Safety Glasses Policy. Technicians must wear proper personal protective equipment during cleaning, including safety goggles, face shields, respirator or proper ventilation if required according to safety data sheets, and proper gloves. Refer to the safety data sheet of cleaning/sanitizing agents for complete safety information. All disinfectant solutions and bottles must be handled through appropriate waste management techniques and labeled with the appropriate handling methods and HMIS labels for secondary containers. Goggles or a full face shield must be worn when mopping ceilings and walls. Use caution when cleaning around electrical outlets, light switches, pressure differential sensors, or light fixtures. Mop around and spray a sterile wipe with IPA to clean around these appliances. Technicians using a PAPR must receive proper training by Health, Safety & Environment (HSE) or a qualified trainer. Do not mix any chemicals together such as oxidizers, acids, and bases without a water rinse step between applications. Always refer to safety data sheets as necessary. 4. GUIDELINES & DEFINITIONS General cleaning and disinfection of CEF areas will be performed with an approved disinfectant as described in SOP UN-023, Ceva Disinfection Program. Cleaning and disinfection of the ceilings, walls, doors, windows, and floors with a sporicide will occur a minimum of once per month for all areas, in accordance with SOP UN-023. Prepare disinfectants in a well-ventilated area and dilute according to SOP UN-023.AT03, Dilutions Quick Reference Guide. Wear gloves to protect skin and any additional PPE as noted in SOP UN-023. All log books will be requested and tracked in accordance with SOP QA-067, Issuance, Return, and Retention of Log Books.  MP-040.06 STANDARD OPERATING PROCEDURE Page 2 of 6 CLEANING OF THE CEF LABORATORY AT BUILDING 8901 4. GUIDELINES & DEFINITIONS (Continued) Area Clearance: Clearing the equipment, workstation, or room of previous product, documents, or materials not required for the planned process and ensuring that the area is clean and suitable for use. Deep Clean: A complete clean and disinfection of the area to include: ceiling, walls, floors, countertops, tables, carts, curtains, laminar flow hoods, and portable equipment. Wait a minimum of 10 minutes before using the area for the next process. Production areas, while in operation, will have a deep clean performed at least once a week. Detergent: A water-soluble cleansing agent that combines with impurities and dirt to make them more soluble. OFFICIAL QUALITY DOCUMENTATION Cleaning: A process that removes visible organic and inorganic material (soil) Disinfectant: A chemical agent designed to inactivate or destroy microorganisms on inert surfaces. Disinfection: A process designed to inactivate or destroy microorganisms on inert surfaces."Horizontal Clean: Clean and disinfection of the area of all workable areas and equipment from shoulder height of a person and below. This would include all countertops, tables, carts, curtains, hood area, portable equipment, floor, etc. Production areas, while in operation, will perform horizontal cleaning during each shift and between each aseptic process. NC: Non-Critical Equipment: Equipment that may be used during a process but does not have direct product contact. Non-Classified: Areas where air particles are not monitored. Product Contact: Surfaces in contact with product, raw materials, or in-process materials. Sanitize: Using a chemical agent to reduce viable microorganisms to an acceptable level. 5. MATERIALS Approved cleaning/sanitizing agents listed in SOP UN-023 Broom and Dust Pan Clean Mop Handle UN-023.AT03, Dilutions Quick Reference Guide DI/WFI H2O (depending on the grade of the area) Equipment Log Book Face Shields or Safety Goggles Gloves Fogger Leak-Proof Container System Mop Buckets Mop Heads Sterile PPE for Entering Labs (Coveralls and boots, facemask, safety goggles, and gloves) Cleaning Log Book Respirator or Proper Ventilation (if needed according to SDS and HS-043.AT01) Safety Glasses Cleaning Solutions Log Book Spray Bottles Sterile Wipes or Shop Towels (depending on the grade of the area)  MP-040.06 STANDARD OPERATING PROCEDURE Page 3 of 6 CLEANING OF THE CEF LABORATORY AT BUILDING 8901 6. PROCEDURE 6.1. General Guidelines 6.1.1. In general, disinfection and cleaning should be done from the cleanest area to the dirtiest area as described in SOP UN-023, Cleaning and Operational Procedure. 6.1.2. All table and shelf surfaces must be cleared of materials and equipment prior to disinfecting. Place the materials and equipment onto a clean cart until the table and shelf surfaces have been disinfected. 6.1.3. All areas within the CEF production area as well as rooms 532 and 538 will be deep cleaned at OFFICIAL QUALITY DOCUMENTATION least once per week. Rooms 573 and 539 will be deep cleaned at the end of each production day. Proper PPE must be used during deep cleaning such as safety goggles/face shield and chemical resistant gloves. 6.1.4. In the event of a production shutdown, daily cleaning and weekly deep cleaning will not be required. Cleaning requirements for each area prior to resuming production will be dictated by QA. 6.1.5. All solutions must be prepared with either DI or WFI H2O. Sterile water must be used for room grades A and B. 6.1.6. Cleaning and disinfection of the floors will occur at least once per day at the end of each work day or process. 6.1.7. Mopping should be done using overlapping strokes so that all surfaces come in contact with disinfectant solution. Change out disinfectant solution at the first sign of discoloration. Continue with mopping using the new cleaning solution and repeat as needed. When mopping overhead, wear safety goggles or face shields rather than safety glasses. Dispose of the disinfectant solution into the appropriate waste system and rinse out the mop bucket. Dispose of used mop heads in a leak-proof container. Spray the mop bucket with IPA and wipe clean. 6.1.8. All room cleaning and fogging must be recorded concurrently onto a cleaning log book. Record all cleaning solution preparations onto a cleaning solutions log book. 6.1.9. All secondary storage containers for cleaning solutions must be labeled with the following information: Solution Name HMIS Code Date Made Expiration Date Initials of the person making the solution 6.1.10. Secondary spray bottles must be replaced at least every 30 days. 6.1.11. Opened bulk solution bottles must have the date they were opened recorded on the bottle. 6.1.12. Mop buckets must be cleaned with 70 % IPA after each use. Mop buckets are labeled with the area in which they are to be used. 6.1.13. In the event of construction being performed in the production area, a triple deep clean of all affected rooms will be performed, with at least one of the cleans performed with bleach or a sporicide prior to production resuming.  MP-040.06 STANDARD OPERATING PROCEDURE Page 4 of 6 CLEANING OF THE CEF LABORATORY AT BUILDING 8901 6.1.14. In the event of two lot contamination events within a week, a deep clean of labs 576 and 572 will take place prior to the start of production the day after notification of the second lot contamination. 6.2. Cleaning of the 8901 Labs Before a Procedure 6.2.1. Update the Room-Suite Status Sign, UN-028.AT01 to show that the room will be in process. 6.2.2. Gown into lab via the lab’s PAL according to SOP UN-044, Gowning Requirements for Production & QC Areas. 6.2.3. Spray all table and equipment surfaces under the laminar flow hood with disinfectant and OFFICIAL QUALITY DOCUMENTATION allow them to sit for a minimum of 10 minutes. If the disinfectant evaporates before the 10 minutes has elapsed, spray the surfaces again to keep them wet. 6.2.4. Wipe down the table and equipment surfaces under the laminar flow hood. Change wipes after they become dirty. 6.2.5. After wiping everything down with disinfectant, saturate the tables, and equipment surfaces with 70% IPA and wipe them down again. 6.2.6. Record the pre-process cleaning onto a cleaning log book. Record the cleaning of equipment onto an equipment log book. 6.2.7. Update the Equipment Status Signs, UN-028.AT03 for each laminar flow hood to show they are in process. 6.3. Cleaning of the 8901 Labs After a Procedure 6.3.1. Remove all used trash bags from trash cans and place them into the MAL to be sent out. 6.3.2. Spray the inside and outside of the trash cans with disinfectant and allow them to sit for a minimum of 10 minutes. 6.3.3. Spray the inside and outside of the laminar flow hood legs and flaps as well as all table and equipment surfaces under the laminar flow hood with disinfectant and allow them to sit for a minimum of 10 minutes. If the disinfectant evaporates, spray the surfaces again to keep them wet. 6.3.4. Clean the laminar flow hood filter covers under hood by saturating a sterile wipe with disinfectant and wiping entire surface, removing all debris on the surface of the filter covers. Do not spray disinfectant directly on covers as this may wet the HEPA filters, damaging them. 6.3.5. Begin wiping down the flaps with sterile wipes or a flap cleaning devise, followed by the laminar flow hood legs, table and equipment surfaces. As before, use overlapping strokes and change out wipes as they become dirty. 6.3.6. After wiping away the disinfectant, spray the laminar flow hood legs and flaps, table, and equipment with 70% IPA and wipe down. 6.3.7. Prepare the mop bucket and spray bottle solutions under the laminar flow hood using sterile DI/WFI water. 6.3.8. Place a mop head onto the mop handles and begin mopping the lab.  MP-040.06 STANDARD OPERATING PROCEDURE Page 5 of 6 CLEANING OF THE CEF LABORATORY AT BUILDING 8901 6.3.9. After mopping is complete, place the mop bucket and mop handles into the MAL to be sent out. 6.3.10. Place trash bags into all of the empty trash cans and place the used mop buckets and mops into the MAL. 6.3.11. Update the Equipment Status Signs, UN-028.AT03 for each laminar flow hood to show they have been cleaned. 6.3.12. Record the post-process cleaning onto a cleaning log book. 6.3.13. Gown out of the lab according to SOP UN-044, Gowning Procedure for Production & QC OFFICIAL QUALITY DOCUMENTATION Areas. 6.3.14. Update the Room-Suite Status Sign, UN-028.AT01 to show that the lab has been cleaned. 6.3.15. Retrieve the trash and mop bucket from the MAL. Place the trash in airlock 534a located at the end of hallway 534. Take the mop bucket and mop handle to kitchen 566 to dispose of the mop solution. 6.3.16. Deep cleaning of the 8901 labs and their respective MALs and PALs will occur a minimum of once per week after all aseptic process have been completed. 6.3.17. The laminar flow hood pre-filters will be replaced a minimum of once per month. 6.3.17.1. A repeating calendar event that will send notifications to the CEF team leadership and technicians assigned to the task will be created to ensure that the pre-filters are replaced on a monthly basis. 6.3.17.2. To replace the pre-filters, use a ladder to climb to the top of a laminar flow hood. Each hood contains six pre-filters. 6.3.17.2.1. Position the ladder outside of the hood and in front of the pre-filter to be replaced. Ensure that the floor underneath the ladder is dry and free of any obstacles that may compromise the stability of the ladder. 6.3.17.2.2. Unfold the ladder and extend it so that the pre-filters can be reached safely while keeping feet flat on the ladder steps. 6.3.17.2.3. Ensure that the safety latches are locked into place before climbing onto the ladder. If there is a safety handrail, extend the handrail and lock it into place for additional stability. 6.3.17.3. Remove each pre-filter individually and immediately replace it with a new one, making sure the arrows indicating the airflow direction are pointed down. 6.3.17.4. Once a pre-filter has been replaced, climb down the ladder and position it adjacent to the next pre-filter. Repeat until all of the pre-filters are replaced. 6.3.17.5. Log the replacement of the pre-filters in the corresponding equipment log for each laminar flow hood.  MP-040.06 STANDARD OPERATING PROCEDURE Page 6 of 6 CLEANING OF THE CEF LABORATORY AT BUILDING 8901 6.4. Cleaning of Grade D Areas in CEF 6.4.1. Grade D areas in CEF consist of rooms 532, 539, 570, 573, 573a, kitchen 566, 565, cooler 564a, and hallway 571 and its constituents. 6.4.2. Cleaning and disinfection of the floors of the above mentioned areas will occur a minimum of once per day at the end of each production day. 6.4.3. Deep cleaning of the above mentioned areas will occur a minimum of once per week while in use for production. Room 539 will be deep cleaned a minimum of once per day after egg disinfection is complete. OFFICIAL QUALITY DOCUMENTATION 6.5. Cleaning of Weigh Room in CEF 6.5.1. Cleaning of the weigh room 532A, PAL 532B, and MAL 540 will occur before and after each use. Deep cleaning with a sporicide will occur a minimum of once per month. 6.6. Fogging of CEF Areas 6.6.1. Fogging of the CEF labs will occur at the end of each work day. Use SOP MP-034, Fogging for CEF and Marek’s as a reference for steps regarding fogging. 6.6.1.1. A PAPR equipped with an organic vapor/acid gas cartridge is required for manual fogging. 6.6.2. Fill out and post MP-034.AT01, Fumigation Sign on the outside of the door to the CEF hallway prior to fogging. 7. DATA MANAGEMENT Completed log books will be reviewed for accuracy and verified before submitting to QA in accordance with SOP QA-067. 8. REFERENCES SOP HS-001, Safety Glasses Policy SOP HS-043.AT01, Respiratory Protection - Attachment 1 Tasks and Respirator Selection SOP MP-034, Fogging with Virkon for Marek’s MP-034.AT01, Fumigation Sign SOP QA-067, Issuance, Return, and Retention of Log Books SOP UN-023, Ceva Disinfection Program UN-023.AT03, Dilutions Quick Reference Guide UN-028.AT01, Room-Equipment Status Sign UN-028.AT03, Status Identification of Laboratories and Equipment 9. ATTACHMENTS N/A