Occupational Safety and Environmental Safety for the Food Industry Lecture 3 PDF

Occupational Safety and Environmental Safety for the Food Industry Jennifer Campbell Lecture 3 © Innopharma  Module Overview This module aims to provide the student with comprehension of Health and Safety in the food industry, including the nature of hazards & their control, biosafety, ris...

Occupational Safety and Environmental Safety for the Food Industry Jennifer Campbell Lecture 3 © Innopharma  Module Overview This module aims to provide the student with comprehension of Health and Safety in the food industry, including the nature of hazards & their control, biosafety, risk assessment, waste management, with emphasis on legal requirements. 5 ECTS Module Breakdown 70% Final Exam – 2 hours 30% Continuous Assessment – MCQ – 9th November Lectures 5x Evenings 1x Saturday Contact Details: [email protected] © Innopharma 2  Module Learning Outcomes LO 1: Discuss the role and responsibilities of employees, employers and regulatory agencies under national and international legal frameworks. LO 2: Explain the types of information contained in a safety statement & discuss the steps in its preparation. LO 3: List the different types of hazards, there routes of exposure, personal protection equipment, along with describe the term safety data sheet and explain the information it contains. LO 4: Discuss both the causes and categories of biohazards and contaminants, the importance of cleaning, and review the different methods of sterilisation. LO 5: Explain the waste management hierarchy, along with discuss the role and function of regulatory agencies. LO 6: Describe how waste material is classified and explain the different methods of treating/disposing of gaseous, liquid and solid waste. © Innopharma  Lecture 2 Biological Hazards Biological Safety Classification of Biohazards Control of Biohazards and Contamination Control © Innopharma  Introduction to Biological Safety © Innopharma  Introduction In the workplace, an employer is obliged by law to perform a risk assessment. To identify potentially hazardous biological agents that present a risk to the health and safety of employees or others. This is in accordance with the Safety, Health and Welfare at Work (Biological Agents) Regulations, Act, 2013. © Innopharma  Sources of Biological Contamination In the manufacturing environment people are the major source of biological contamination. We carry bacteria and viruses (saliva, mucous, bodily wastes, skin, hair). Every time we move, talk or sneeze we generate millions of particles e.g. walking produces 7.5 million particles per minute. By moving: we shed millions of particles into the environment or into a product!!!! © Innopharma  Sources of Biological Contamination Particles are transported in air currents and then land on surfaces. Mostly dead skin cells that are shed from our bodies. People are not the only source of contamination. Other sources include: o Air o Buildings o Equipment o Water o Raw Materials o Packaging etc. © Innopharma  Causes of Biological Contamination Biohazards or microbes cause biological contamination. Collective term for agents that cause disease. Therefore bacteria, viruses, fungi are considered to be biohazards. These can occur naturally in sewage, raw meat, blood/body fluids, urine/faeces. Can cause: o food poisoning o winter vomiting bug o various infections o sexually transmitted infections o blood borne diseases e.g. (HIV, Hepatitis B and C). © Innopharma  Microbes are all around us! © Innopharma  Bacteria and Spores Vegetative bacteria are living microscopic organisms that are actively growing and reproducing. Present everywhere! Some are commercially useful. Others are undesirable! © Innopharma  Bacterial Division © Innopharma  Bacteria and Spores © Innopharma © Innopharma 14 Bacteria and Spores: Gram Stain © Innopharma  Bacteria and Spores © Innopharma  Bacterial Spore Formation © Innopharma  Viruses Viruses are infectious agents that invade and replicate in living organisms (human, animal, bird, algae). They are capable of causing disease Examples: Influenza virus causes flu, herpes simplex virus causes cold sores. © Innopharma  Fungi Plant-like organisms. They lack chlorophyll They take nutrients from their environment. Examples: Moulds, mildews, yeasts, mushrooms They can also cause disease in humans. Examples: Ringworm, Athlete's Foot © Innopharma  How do Biohazards enter the body? Injection – Absorption direct Inhalation Ingestion – skin / eye contact with blood © Innopharma  Classification of Biohazards © Innopharma Classification of Biohazards Based on: o How likely they are to cause disease (pathogenicity) o Whether low, moderate or high doses are required for infection o Mode of transmission (via ingestion or the highly contagious aerosol route) o Whether or not effective treatments are available (drug therapies or vaccines). © Innopharma Classification of Biohazards The European classification system for biological agents is defined by Directive 2000/54/EC on the protection of workers from risks related to exposure to biological agents at work. Risk Group 1 No or low risk to individuals and community Risk Group 2 Moderate risk to individuals, low risk to the community, effective treatment available Risk Group 3 High risk to individuals, low risk to the community, effective treatment usually available Risk Group 4 High risk to individuals and the community, no effective treatment available © Innopharma © Innopharma 25 Group 1 Risk: Low individual and community risk …......Unlikely to cause disease in healthy individuals Example: Bacillus subtilus and food grade organisms Biosafety Level: BSL-1 - Basic lab practices © Innopharma Group 2 Risk: Moderate individual risk & low community risk …......Can cause human disease at high infectious doses only Transmissible via body fluid/ ingestion Effective drug therapies/vaccines available Example: Hepatitis B virus (HBV), Human immuno - deficiency virus (HIV) Biosafety Level: BSL-2 - Intermediate containment practices © Innopharma Group 3 Risk: High individual risk & low community risk …......Can cause serious human disease, moderate doses Transmissible via body fluid/ ingestion and aerosol Effective treatments available Example: Mycobacterium Tuberculosis (TB). Biosafety Level: BSL-3 - High level containment practices © Innopharma Group 4 Risk: High individual risk & high community risk …......Can cause serious human disease, life threatening Low/very low doses required Transmissible via body fluid/ ingestion and aerosol No treatments available Example: Ebola virus. Biosafety Level: BSL-4 - Maximum containment practices © Innopharma  BSL-4 Containment © Innopharma  Consequences of Biohazard Contamination Bio-contamination Unintended presence of biological agents, such as bacteria, viruses, fungi, and other microorganisms, in environments where they are not supposed to be. Sources Impacts Prevention/ Control © Innopharma  Consequences of Biohazard Contamination Spoilage The contamination that makes a product unfit for consumption Sources Impacts Prevention/ Control © Innopharma  Consequences of Biohazard Contamination More serious is the effect a contaminated product may have on people Important if the product is destined to enter the human body e.g. pacemakers, artificial hip joints, food. So the product should be sterile [should be completely free of ‘viable’ (living) organisms]** Essential to consider: method of delivery that will allow the biohazard to enter straight into the bloodstream Thus, bypassing the body’s natural defenses presented by the digestive system. Consequently …. it is vital that microbes do not contaminate products. This highlights the importance of contamination control. © Innopharma  Control of Biohazards/ Contamination Control © Innopharma © Innopharma  Control of Biohazards/ Contamination control Bio-decontamination 1. Eliminate 2. Remove contamination, by: o Cleaning o Disinfection o Sterilisation © Innopharma © Innopharma  1. Cleaning Definition: A process using detergent and water that physically removes contamination such as dirt, dust and residues but not necessarily microbes. Detergents are used in the cleaning process to speed up the dissolution of residues in water Important to remove dirt/dust as they protect microbes from contact with decontaminants such as disinfectants © Innopharma  Industrial Cleaning © Innopharma 1. Cleaning Dirt can also neutralise many disinfectants. Cleaning reduces the number of microbes so that decontamination is more effective Therefore, pre-cleaning is essential for effective disinfection and sterilisation. © Innopharma Critical Variables in Cleaning 1. Temperature 2. Type of cleaning process (manual versus auto) 3. Chemistry of residues 4. Type and concentration of cleaning agent 5. Rinse method © Innopharma  Cleaning Process Critical cleaning o It is used for items entering sterile tissue and destined to remain in the body e.g. pacemakers, injectable drugs. o Process must be validated using validated cleaning agents and is performed by trained staff. Semi-critical cleaning o It is used for items making short-term contact with the body. o Contact with mucous membranes (but intact), but not internal. o Typically instruments – probes, endoscopy, surgical forceps, stethoscopes Non-critical cleaning o Something that comes in contact with intact skin but not mucous membranes. o Is used for general-purpose items. o Examples: beds, rails, door handles © Innopharma  Cleaning Process (Food Context) Critical cleaning o Food contact areas/ equipment (sterile typically not relevant) o Conveyor belts, mixers, slicers (particularly post-kill step) Semi-critical cleaning o Areas/ equipment that do not come into direct food contact but are in close proximity to food production areas. o Exterior surfaces of machines, handles, control panels. Non-critical cleaning o Areas/ equipment remote from food production o Non-production equipment, office areas, break rooms © Innopharma © Innopharma 44 IMPORTANT! Disinfection DOES NOT replace cleaning If a surface is contaminated and has not been cleaned, the contamination may interfere with the effectiveness of the disinfectant. So CLEAN then DISINFECT © Innopharma Selecting Cleaning Agents The type of soilage The type of surface Odour Range of action Composition of cleaning agent Ease of use, saving effort & time No side effects Shelf life Packaging volumes & quantities Cost effectiveness © Innopharma 7 Basic Types of Cleaning Agents 1. Water 2. Natural Soap 3. Synthetic Detergents 4. Solvent Cleaners 5. Acid Cleaners 6. Alkaline Cleaners 7. Abrasive Cleaners © Innopharma  The Cleaning Operative Appropriate PPE: o Gloves o Apron/ coveralls o Goggles o Mask o Full toe shoe/ safety shoes Standard of hygiene/ appearance: o Clean o Tidy appearance o PPE always worn o Minimal jewellery o Hair tied back © Innopharma © Innopharma © Innopharma © Innopharma  2. Disinfection Definition: A process that destroys pathogenic microbes but not necessarily spores or large microbial populations The process should be viewed as a two-step process: 1. Cleaning with detergent and water 2. Then a chemical disinfection © Innopharma  Chemical Disinfection May kill or suppress the growth of microbes. Chemical disinfectants that can kill microbes frequently have the ending –cide or –cidal. This means to kill e.g. bacteriocidal agents for killing bacteria, fungicidal agents for killing fungi and viricides for killing viruses. Some chemical agents are powerful enough to kill bacterial spores are called sporicides. © Innopharma  Chemical Disinfection If an agent does not kill but prevents the growth of microbes the ending -stat or –static This means to stay the same i.e. the microbial population doesn’t multiply but stays the same e.g. bacteriostatic and fungistatic agents. So once the agent is removed, growth resumes. Some disinfectants are –cidal at high concentration but –static at lower concentrations. © Innopharma  Disinfection Process High Level Disinfection (HLD) Used for critical items and destroy all microbes (not necessarily kill spores). Some disinfectants may however have good sporicidal activity (kill spores) oReferred to as a chemical sterilant (growing bacteria and spores) because they can kill all microbes e.g. formaldehyde. Examples: Hydrogen peroxide, Chlorine Dioxide, Glutaraldehyde Uses: Food contact surfaces, semi-critical medical devices © Innopharma  Disinfection Proces Intermediate Level Disinfection (ILD) Used for semi-critical items and destroys bacteria. Do not necessarily kill all viruses or fungi and unlikely to kill spores e.g. ethanol. Examples: Alcohols (Ethanol), Phenolics, Chlorine compounds Uses: Food utensils/ equipment that contact non-RTE, non-critical medical devices that come in contact with skin © Innopharma  Disinfection Proces Low Level Disinfection (LLD) Eliminates most bacteria, some viruses and fungi, NOT spores. Examples: Diluted bleach solutions Uses: General cleaning of floors, walls, surfaces © Innopharma  Types of Disinfectants: ALCOHOLS Ethanol and isopropyl alcohol (IPA) are widely used as disinfectants. Diluted to 70% (v/v) with water. They are bacterocidal against Gram+ve and Gram-ve bacteria. They have little effect against viruses or fungi and are not sporicidal. Alcohols: fast acting and does not leave a residue. Also compatible with other disinfectants. © Innopharma  Types of Disinfectants: ALDEHYDES Two aldehydes are used o Formaldehyde o Glutasaldehyde They are active against/kill: o Gram+ve & -ve bacteria o Viruses o Fungi o Spores © Innopharma  Types of Disinfectants: CHLORINE COMPOUNDS Gas at room temp. Commonly used as disinfectant in water for domestic use Use being reduced as suspected to be a carcinogen Inorganic chlorides, mainly hypochlorites (bleach) are widely used disinfectants Cheap but breaks down quickly and needs frequent application Active againts: o Gram+ve & -ve bacteria o Viruses o Fungi o Some Spores © Innopharma  Types of Disinfectants: IODINE AND IODOPHORS Iodine has a rapid effect o Active against gram+ve & -ve bacteria, viruses, fungi and spores o Poorly soluble in water o Stains the skin, causes irritation © Innopharma  Types of Disinfectants: IODINE AND IODOPHORS Iodine has a rapid effect o Active against gram+ve & -ve bacteria, viruses, fungi and spores o Poorly soluble in water o Stains the skin, causes irritation To overcome these, iodophors were developed. o Iodine in a complex w/ solubilising agent o Releases iodine into solution o Retains the activity of iodine o More stable, less staining and irritating to the skin e.g. surgical disinfectant betadine © Innopharma  Types of Disinfectants: PHENOLS Phenol or carbolic acid was one of the first used antiseptics. Phenolic compounds are effective against: o Bacteria o Fungi o Not sporicidal. Can damage rubber and plastics and leave residues. Carcinogen. © Innopharma Limitations of Disinfection 1. Spores may not be killed 2. Different disinfectants may need to be used for different species of microbes 3. Leave an undesirable residue and may damage instruments 4. Microbes can become resistant to disinfectants so it may be necessary to rotate disinfectants 5. Waste is a hazard and needs to be disposed of correctly/ responsibly © Innopharma  Terminology Reminder Cleaning General removal of debris (dirt, food, faeces etc.) Reduces amount of organic matter that contributes to proliferation of bacteria and viruses Disinfection Removes most organisms present on surfaces that can cause infection or disease Sterilisation Eliminates all living microorganisms, including bacterial spores © Innopharma 66  Swab Testing Used to collect bacteria from irregular surface, person, thing… Environmental (wall, floor, machine) and personnel (hands, gloves) monitoring. METHOD: Moisten the swab with sterile water. Role the swab on the surface to be tested. Open the agar plate, spread the swab over the surface. Incubate plates (37°C 2 days) Count the number of colonies. RESULT: Large number = lots of microbes present. © Innopharma © Innopharma  Results © Innopharma  Microbial Test After Disinfection: Swabbing © Innopharma  Contact Plate Testing Used to collect bacteria from flat surface Wall, floor, bench, chopping board etc. Very similar process to swabs. Need to ensure clean surface that has been plate tested so as not to leave “food” behind for bacteria. © Innopharma © Innopharma  3. Sterilisation Definition: The complete destruction of all microbes including bacterial spores and can be achieved using thermal or non-thermal methods Thermal methods = involves the generation of heat Non-thermal methods = do not involve heat (other methods) Method used depends on nature of the product to be sterilised (heat stable or not) © Innopharma  Terminal Sterilisation This involves sterilising the product after it has been packaged and sealed in its final container. Most parenteral (injectable) products manufactured cannot be terminally sterilised. o Sensitive to the sterilisation methods used e.g. With heat, they are thermolabile (easily destroyed by heat) Sterile filtration can be used for thermolabile products but the risk of producing a contaminated product is high and contamination controls must be strictly enforced. © Innopharma Common Methods of Sterilisation 1. Heat (Dry and Moist - both kill) 2. Radiation (kills) 3. Filtration (does not kill bacteria, just removes them) 4. Chemical Sterilants (kills) 5. Incineration (kills) © Innopharma  Sterilisation Methods: Heat (Thermal) Most popular & widely used For products that are stable at high temperatures (i.e. not thermolabile) Two forms: 1. Wet (Moist) Heat 2. Dry Heat © Innopharma 76  Sterilisation Methods: Moist Heat - Autoclave Bacteria are more readily destroyed by moist heat (steam) in an autoclave. Moist heat reliably kills moderate numbers of bacterial spores (15 minutes at 121°C, 15 psi). So items to be sterilised in an autoclave must allow steam access to all internal spaces and surfaces. o Glassware must have loose fitting tops. Wrapped items allows moisture in but not microbes. o Uses a combination of heat and saturated moisture to kills bacteria and spores. o By: damaging protein in the cell wall). © Innopharma  Autoclave © Innopharma © Innopharma 79  Sterilisation Methods: Dry Heat - Oven Carried out in a hot air oven Limited to items that can withstand the effects for >2hrs at 160-180°C Used to sterilise materials such as: o Glassware o Metal objects o Oily materials Items containing volatile liquids, plastics or rubber usually not suitable © Innopharma  Sterilisation Methods: Radiation Ionising Radiation e.g. alpha (ά), beta (β), gamma (γ), X -rays and electron beams. Gamma rays and electron beams are the most common types of ionising radiation & are used to control the growth of microbes. Their main application: dry pharmaceutical products, disposable plastic medical devices and surgical instruments. © Innopharma  Sterilisation Methods: Radiation Non-ionising Radiation UV Light Range 240-280nm (peak at 260nm) is highly lethal to microbes Is in the ultraviolet region of the light spectrum (non- ionishing type) Disadvantages: o Does not penetrate through packaging o Will not penetrate dirt o Will not penetrate glass © Innopharma © Innopharma  Sterilisation Methods: Filtration Definition: Process involves passing the solution through a filter membrane so it only applies to liquid products. AIM: Retain bacteria on the filter while the solution itself passes through FUNCTION: Removes bacteria but does not kill them USED FOR: Products that are thermolabile substances (decomposed by heat) © Innopharma  Sterilisation Methods: Filtration Can be used for both aqueous and low viscosity oily solutions All apparatus used including, the filter assembly and final containers must be pre- sterilised before use to ensure they are free of viable microbes. It is used in aseptic processing to sterilise solutions before they are filled into ampoules and vials. © Innopharma  Sterilisation Methods: Filtration © Innopharma  Sterilisation Methods: Chemical Definition: Chemical agent that kills bacteria, spores, virus, fungi Should have all the following characteristics: 1. Toxic enough to kill large numbers of microbes (including bacterial spores) in a relatively short period of time. 2. Have little or no toxicity towards humans. 3. Have good penetration power (it can get into all parts of the area/product to be sterilised). 4. Leave little or no residue. © Innopharma  Sterilisation Methods: Chemical No such thing as an ideal chemical sterilant with all these characteristics A few chemicals that come sufficiently close to the above characteristics to be considered reliable enough for use. These chemicals include: o Formaldehyde and glutaraldehyde. o Ethlyene Oxide. o Peracetic acid. o Hydrogen peroxide. © Innopharma  Formaldehyde Colourless, highly toxic gas with an odour and is very soluble in water. At 37 - 40% (by weight) solution is known as formalin. It is effective against both bacteria and spores. A major disadvantage is that it is an irritant and harmful and may be carcinogenic. For this reason, its use is becoming less and less widespread. © Innopharma  Ethylene Oxide (ETO) Carried out in airtight chambers similar to steam autoclaves. Long time required: necessary for the gas to penetrate the inner-most areas of the load of items, ETO sterilization can be slow (24 hours or more). Sterilised products are placed in quarantine for a lengthy period to allow outgassing (i.e. to allow the gas disperse away) so ETO concentration down to a safe level. Possible carcinogen and its use is becoming less common. © Innopharma  Conclusions Contamination and Biocontamination is a serious problem and has to be carefully controlled Some products have to be kept free of microbes or they pose a threat to health Decontamination means eliminate or remove microbes. Achieved by: Cleaning, disinfection, sterilisation © Innopharma  Assessment: MCQ - 30% Saturday 9th November 2024 – 10:05am Lectures 1, 2, 3 content 20 minutes, 20 questions Answer ALL questions Multiple choice: A, B, C Cannot go back to previous questions CA is ONLY available during this time period, and will then close immediately at 10:30am Take a break and join class at 10:45am © Innopharma  Tips Refresh screen at 10:05am Close all other applications running on your Wi-Fi Read questions carefully Attempt ALL questions © Innopharma