General Introductions of Methods of Sterilisation As per Ph. Eur. General Chapters 5.1.1

General Introductions of Methods of Sterilisation As per Ph. Eur. General Chapters 5.1.1 Part -2

Sterilisation may be carried out by one of the methods described hereafter. Modifications to, or combinations of, these methods may be used, provided that the chosen procedure is validated with respect both to its effectiveness and to the integrity of the product including its container. For all sterilisation methods, the critical parameters of the procedure […]

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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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