Sterility is the complete absence of organisms. Sterility is absolute. 'Sterile' describes product. 'Aseptic' describes a procedure. All organisms should be considered as potentially damaging to patients
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What are the basic axioms? (2)
All living organisms should be excluded, removed, destroyed with the highest level of probability. SAL has no meaning in the context of aseptic processing. Aseptic processing is not a method of sterilisation
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What are the basic axioms? (3)
Whenever possible, sterile products should be terminally sterilised
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Outline the factors in the process of pharmaceutical microbiology
Bulk manufactured product (raw materials, premises/environment, equipment, operator). Finalised product (equipment, container). Ready for use (diluent, handling). During use (user, storage conditions)
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Describe features of the sources of contamination - raw materials (1)
Need to determine that each material is genuine (e.g. API, preservatives), would want raw materials in anhydrous form (not exposed to water content, reduce risk of microbial growth), check microbial content in raw materials (types of species)
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Describe features of the sources of contamination - raw materials (2)
Where raw materials were stored previously, where raw materials should be stored next, need to know the country where raw materials are sourced from (certification/standards/regulations)
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Describe features of the sources of contamination - raw materials (3)
What exposure has the raw materials had (opportunistic pathogens), natural or synthetic source (synthetic – control of material during formulation, synthetic reactions
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Describe features of the sources of contamination - raw materials (4)
e.g. temperature, pH, solvents could reduce microbial content, natural – exposed to various factors, compliance with control)
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Describe features of the sources of contamination - raw materials (5)
Herbal medicine – confidence for use – know storage conditions (some form of certification by a trusted body), could test formulation for source of contamination
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Describe features of the sources of contamination - premises and environment (1)
Effects of environment on microbial growth (e.g. temperature, oxygen, storage), preferred conditions (temperature – depending on types of organisms (usually low temperatures), aseptic techniques
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Describe features of the sources of contamination - premises and environment (2)
Low temperature, low humidity, control ventilation (control air in the room), avoid bacteria in particles, high efficiency particle air filters used, filtered/dry air, higher pressure in the room (laminar flow)
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Describe features of the sources of contamination - premises and environment (3)
Slow/deliberate movements that will not disrupt the air flow in the room, no open windows (ruin air flow, have fittings which are not cleaned easily), could use internal windows (no fixtures, able to clean easily, health and safety, communication)
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Describe features of the sources of contamination - premises and environment (4)
Good lighting, type of paint on walls able to withstand cleaning agents, composite floor, metal benches, temperature – 16-18 degrees Celsius (discourages bacterial growth but also people in work in the area)
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Describe features of the sources of contamination - processing (1)
Technicians wearing gloves, eye protection, protective clothing etc to prevent spread of contamination, equipment (use alcohol to decontaminate)
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Describe features of the sources of contamination - processing (2)
Need validation that cleaning technique/agents are suitable (check for carry over of product), establish a validated cleaning procedure, check cleaning procedure is being followed
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Describe features of the sources of contamination - processing (3)
Cannot apply every cleaning agent to every type of equipment (metal equipment – doesn’t rust, able to survive harsh conditions, able to apply cleaning agents, durable)
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Describe features of the sources of contamination - personnel
Leave outside clothes, wear sterilised clothing, hair net, mask, no piercings, jewellery, make-up, training, no employees with infectious diseases/open wounds
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Other cards in this set
Card 2
Front
What are the basic axioms? (2)
Back
All living organisms should be excluded, removed, destroyed with the highest level of probability. SAL has no meaning in the context of aseptic processing. Aseptic processing is not a method of sterilisation
Card 3
Front
What are the basic axioms? (3)
Back
Card 4
Front
Outline the factors in the process of pharmaceutical microbiology
Back
Card 5
Front
Describe features of the sources of contamination - raw materials (1)
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