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Summary Sterilisation testing
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Summary of the different types of sterilisation and how we can test for sterility.
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SterilizationBook- Pharmaceutical Dosage Forms - Parenteral Medications, Third Edition: Volume 2:
Facility Design, Sterilization and Processing.
https://r4.vlereader.com/Reader?ean=9781420086461
Also:
15.1 onwards https://www.librarysearch.manchester.ac.uk/discovery/fulldisplay?
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Define sterilization.
Absolute term
Ability to destroy all life forms.
How to determine the sterilisation method
o Microbe needs to be removed:
o Can it survive the method?
o Can it withstand high temperatures etc?
o Level of sterility
o Surgical equipment: very sterile
o Lab equipment: less sterile
o Material compatibility:
o Can it withstand the sterilization process?
o Can it survive in high temperatures or pressures?
o Or will it damage the product?
o Cost
o Speed and efficacy
o Environmental impact-will it give off gases?
Use the EMEA decision tree which questions all of these factors and makes a decision on
which is best.
Sterilization standards
o Tells you what sterilisation should achieve.
o Not how to do it
o Ensures the elimination of all forms of microbial life.
o To sell the product they need to meet certain standards.
o So, testing needs to be done.
o Regulated by the EN and FDA
Traditional methods
o Filtration
o Dry heat
o Moist heat (steam)
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