European Pharmacopeia: Preparation of sterile products

The European Pharmacopeia has put the following revised chapter out for public comment:

“5.1.1. METHODS OF PREPARATION OF STERILE PRODUCTS”

The chapter states:

Sterility is the absence of viable micro-organisms, as defined by a sterility assurance level of 10^{− 6}. Sterility is a critical quality attribute for a wide variety of human and veterinary preparations, including but not restricted to:

• Preparations administered to normally sterile areas of the body, such as parenteral and ophthalmic preparations, some irrigation and inhalation preparations, intramammary and intrauterine preparations;
• Preparations applied to severely injured skin, such as semi-solid preparations for cutaneous
• application;
• Preparations that are supplied sterile in order to prolong the shelf life of the product.

With the revised chapter, the following revisions are proposed: 

• In the introduction, the reference to GMP has been removed;
• In the section Sterility assurance level, the reference to exponential inactivation has been removed as membrane filtration is not a first order process;
• The sections on the different sterilisation processes, where appropriate, now have the same format: principle, equipment, sterilisation cycle, cycle effectiveness and routine control; where required, relevant information has been added;
• Modern concepts for validation of steam sterilisation have been added;
• A wider description of the equipment suitable for dry heat sterilisation has been provided;
• In the section Ionising radiation sterilisation, the reference to European Notes for Guidance
• has been removed;
• In the section Gas sterilisation, two different types of agents are defined: alkylating agents and oxidising agents. The establishment of the cycle effectiveness has been described in more detail;
• In the section Membrane filtration, the description of the microbial challenge test has been removed as it is proposed for inclusion in the revised chapter on biological indicators;
• In the section Aseptic preparation, freeze-drying under aseptic conditions is added.

The proposed revision is published in Pharmeuropa which is the free online publication from the EDQM.

Posted by Tim Sandle