A state of being free from biological contaminants. Quality/condition of being sterile. Has effects on product quality, efficacy, safety (of patient)
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What are sterile products? (1)
Have to be sterile, go into vulnerable patients, if microbes are introduced when administering products (complications), effects on patient (infection/illness)
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What are sterile products? (2)
Free from all viable life forms (nothing living/growing, no metabolic processes which can alter the product e.g. micro-organisms, contaminants). Safety, efficacy, quality, fit for purpose
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State features of highly specialised products with strict requirements (1)
Beyond just sterility. Needs to free from other contaminants e.g. particles, pyrogens (not living contaminants)
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State features of highly specialised products with strict requirements (2)
E.g. injections – circumventing natural barriers of infection in the body, eye drops (prevent eye infections, natural barriers to prevent eye infections, don’t want large bacterial burn)
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State features of highly specialised products with strict requirements (3)
Implants, diagnostic injections, insulin injections, IV/IM/SC injections, dressings (on open wounds, natural barrier is compromised), saline solution
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Give examples of pharmaceutical products which are in the non-sterile classification
Tablets and capsules, suspensions. Quality needs to be fit for purpose e.g. tablets - have different criteria, not a high bio-burden, low risk of microbial contamination, may need preservatives
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How are sterile products produced? (aseptic processing)
Start with sterile product, series of manipulations, sterile product remains at the end (nothing introduced to contaminate product)
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How are sterile products produced? (terminal sterilisation)
Introduce product, put in sealed container, make best quality product, apply sterilisation techniques (to ensure sterility step works)
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What are the sources of contamination?
Raw materials, premises, equipment and personnel
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What are the important concepts in pharmaceutical microbiology? (1)
Good manufacturing practice, quality assurance (assessment of the processes which lead to the final product (ensure product is fit for purpose), SAL (sterility assurance level, confidence that you have achieved goal, product is sterile, quantitative)
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What are the important concepts in pharmaceutical microbiology? (2)
Quality control (tests to determine the quality of the product)
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What are the basic axioms? (1)
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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Other cards in this set
Card 2
Front
What are sterile products? (1)
Back
Have to be sterile, go into vulnerable patients, if microbes are introduced when administering products (complications), effects on patient (infection/illness)
Card 3
Front
What are sterile products? (2)
Back
Card 4
Front
State features of highly specialised products with strict requirements (1)
Back
Card 5
Front
State features of highly specialised products with strict requirements (2)
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