Sources of Contamination 0.0 / 5 ? PharmacyPH1123UniversityAll boards Created by: amazingemilyjonesCreated on: 10-04-19 19:59 Sources of Contamination Sources of Contamination 1 of 8 Sources - Water Reduction in microbial count from water samples Chemical treatment Chlorine - Cl Chlorination Sodium hypochlorite - NaCl 0.5-5ppm of free chlorine for most purposes 50-100ppm of free chlorine for storage and distribution Membrane filtration UV irradiation Short wavelength (250nm) Heating 2 of 8 Sources - Operators Contamination from skin (e.g. S aureus) transient and resident microorganisms can be associated with poor hygiene Contamination from respiratory tract coughs and sneezes Reducing contamination from operators Gloves Face masks Shoe covers Hair nets 3 of 8 Sources - Surfaces Building Walls and ceiling moulds a common flora (poorly ventilated buildings and painted walls) use of disinfectants, laminated plastic, ventilation (filtration) Floors and drains easily cleaned drains avoided in areas where sensitive products are being manufactured Doors, windoes and fittings prevention of dust permit only light entry 4 of 8 Sources - Surfaces Packaging Contain the product (e.g. solution, dressing) Prevent the entry of microorganisms (e.g. rubber cap) Prevent the degradation of the product during storage (e.g. light, moisture) Withstand the appropriate sterilisation process heat sterilisation gas sterilisation 5 of 8 Sources - Surfaces Equipment Variety of equipment pharmaceutical manufacture surgical equipment critical, semi-critical, non-critical items Reduction in microbial count sterilisation (physical and chemical) disinfection single use items 6 of 8 Sources - Raw Materials Products of natural origin animal: gelatine, desiccated thyroid, growth hormones plant: starches, gum acacia British Pharmacopoeia: strict controls of E.coli, Salmonella spp. in particular Reduction in microbial count from water samples minimum water activity: spoilage packaging (paper) liquid and semi-solid raw materials (sometimes kept at higher temperature, but extra cost to company) 7 of 8 Sources - Atmosphere Filtration High-efficiency particulate air (HEPA) filters can remove up to 99.997% of particles greater than 0.3um in diameter Complete room, confined to specific area (laminar air flow cabinet, isolators) High-pressure rooms (positive pressure): keeps atmospheric contamination out Chemical disinfection UV irradiation 8 of 8
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