What are the 3 main types of contamination?
chemical
biological (bacterial, fungal, viral)
physical
What are possible sources of biological contamination?
any from: utilities, facilities, process, contaminated product, equipment, materials and personnel
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What are the 3 main types of contamination?
chemical
biological (bacterial, fungal, viral)
physical
What are possible sources of biological contamination?
any from: utilities, facilities, process, contaminated product, equipment, materials and personnel
What controls can we take to reduce risk?
environmental controls, clean prep areas, personnel controls such as PPE.
disinfection/ antisepsis
sterilisation
preservation
What aseptic techniques can we use to reduce contamination?
bunsen burners, biosafety cabinets, laminar flow cabinets, isolators.
What are grade C/D production areas?
clean areas for carrying out less critical stages for sterile products
What are grade B production areas?
In case of aseptics, background for grade A.
What is a grade A prep area?
local zone for high risk operations, most stringent.
What are the 2 types of standards for water?
purified water for non sterile applications such as basic preparations like cough syrup.
Water for injection used in sterile applications.
How many microbes are on face skin?
100 million
What is the purpose of hand washing?
reduce risk of transmission of contaminants.
What are the methods of plate counts for counting microbes?
pour plate, spread plate and drop count
What other 3 ways can we count microbes?
optical density, direct microscopy and flow cytometry
What equipment is used to do a total microbial count?
haemocytometer, which uses multiple FOV
In bacteria, yeast and mould we are able to see colonies. However in viruses colonies cannot be observes, what can?
absence of growth and plaque forming units
What is the equation for colony forming units?
CFU/ml= number of colonies x (solution x number of aliquots in 1ml)
What terms the official standards for UK medicinal products and substances?
british pharmacopoeia
What is defined for sterile products?
must contain no microbial contaminants and additional criteria
What are the effects of spoilage?
chemical and physical deterioration, inactivation of product, breakdown of thickening/suspending agents.