General Introductions of Methods of Sterilisation As per Ph. Eur. General Chapters 5.1.1
Sterility is the absence of viable micro-organisms, as defined by a sterility assurance level equal to or less than 10– 6. Sterility is a critical quality attribute for a wide variety of human and veterinary preparations, including but not restricted to: — preparations required to be sterile due to their route of administration, such as parenteral, ophthalmic […]
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