European Pharmacopoeia sterilization methods

In the Note for guidance and development of pharmaceuticals, the section on the manufacturing process stipulates clearly that, wherever possible, products intended to be sterile should be terminally sterilized in their final container. The methods of sterilization considered as terminal by the European Pharmacopoeia [5] are steam, dry-heat, gas or gamma-radiation sterilization. If terminal sterilization is not possible, sterilization filtration or aseptic processing are authorized but the choice must be fully justified. 

Liquid formulations for parenteral use require preparation methods and composition that make the formulation stable and sterile. Other requirements for parenteral formulations are given by the European Pharmacopoeia such as tonicity, efficacy of the antimicrobial... 

The inadequacies of the Test for Sterility are acknowledged in the pharmacopoeias themselves. The European Pharmacopoeia does not have a long his-tory of publication three of its four fascicules cany a disclaimer to the Test for Sterility. Only in 1971 did the EP publish an imembellished method description and sampling plan. Each of its next revisions, EP 1978, EP 1980. and EP 1986 start their sections headed Test for Sterility with an italicized paragraph stating the following ... 

All sterilisation processes should be validated. Particular attention should be given when the adopted sterilization method is not described in the current edition of the European or other relevant pharmacopoeia, or when it is used for a preparation which is not a simple aqueous or oily solution. Where possible and... 

European Pharmacopoeia. Strasbourg, EDQM 2014 version 8.0. Chapter 5.1 General texts on microbiology, 5.1.1. Methods of preparation of sterile products... 

Although all major pharmacopoeias now cite the 10 SAL for all methods of sterilization, the USP goes further in its recommendations concerning irradiation than its European counterpart. An approach to validation of the 10 SAL is... 

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