Control of sterilisation processes Flashcards
What is quality control?
Involves testing of the final product
What is quality assurance?
Designed to assure that ALL STAGES of the manufacturing process contribute to the overall quality of the end product
In N samples, what is the probability of all being non-infected? (i.e passing sterility test)
q^n
What are the limitations of the sterility test?
Does not necessarily mean the batch is sterile
Only detects gross failure
Not used on it’s own
What are the physical indicators used in heat sterilisation?
Digital record of temp (taken at the coolest part of the steriliser)
What are the physical indicators used in gaseous sterilisation?
Leak tests and Pressure testing
What are the physical indicators used in Radiation sterilisation?
Plastic dosimeter (darkens in proportion to radiation)
What are the physical indicators used in Filtration
Bubble point pressure test
How do chemical indicators work?
Usually melt or change colour (which can be observed)
Don’t necessarily correspond to microbial sterility
What is an example of a chemical indicator?
Browne’s tubes
How do Browne’s tubes work?
Heat –> Acid produced –> Colour change
- Speed of reaction determined by temperature
- Different types for moist/dry heat
What is parametric release?
- Based on process data collected DURING manufacturing instead of sterility testing
- All relevant parameters (e.g temp, pressure, time etc) must be controlled and measure
- Only applied to products that are terminally sterilies in their final container
- Each cycle includes chemical or biological indicators
How are pyrogens removed?
Very high heat (250C, 30min) Distillation Ultrafiltration Ion-exchange chromatography Alkali or oxidising agent treatment
