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 …