How sterility assurance levels differ between aseptic processing and terminal sterilization

Berkshire Sterile Manufacturing

by Sarah Kinney


The sterility assurance level (SAL) is a useful tool for assessing and describing the effectiveness of your sterilization process. SAL describes the probability that a viable unit or colony forming unit (CFU) survives sterilization. If your product is terminally sterilized it has a SAL of 10-6 (i.e. only one in one million CFUs will survive terminal sterilization) while an aseptically processed product as a higher risk SAL of 10-3 (a one in one thousand chance of survival).

A 10-6 SAL is required for injectable products or for products that come into contact with broken skin UNLESS the product is incapable of withstanding the sterilization process and no alternative is available. In the latter case, the product can be aseptically processed. Aseptically processed products have a much higher risk of contamination, so it is critically important to design aseptic processing systems to enhance the SAL for your drug production.

An upcoming webinar hosted by Contract Pharma and sponsored by Nelson Labs and Sterigenics addresses some of the concerns about drug production using terminal and aseptic processing. They will discuss the following:

• Examine the goal and science of sterility assurance including the revision of AAMI ST67
• Introduce and contrast Terminal Sterilization and Aseptic Processing of drug products through a regulatory lens as well as that of a manufacturer
• Discuss modification strategies to consider in order to use Terminal Sterilization

To enroll for this simply follow this link.

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