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What standards must I follow for my gamma sterilization validation?

By November 15, 2016General

Validating sterility is one of the most important steps in the validation process. It ensures that your product is free from viable organisms. Any compromise in sterility can result in infection or even death. In most situations a sterility assurance level (SAL) of 10-6 is preferred (i.e. a 1 in a million chance of a non-sterile unit). This SAL is not absolutely necessary, though, depending on your requirements and product capabilities.

So what standards must you follow? ANSI/AAMI/ISO 11137 is the main guidance for the sterilization of health products. Like most standards, it is broken into two parts: 11137-1 & 11137-2.

ANSI/AAMI/ISO 11137-1 describes the overall requirements needed for the development of the sterilization process. Think of it as a general overview of the processes involved, including establishing dose, equipment validations, sterilization audits, and maintenance of equipment.

ANSI/AAMI/ISO 11137-2 describes the different types of validation methods, including VDmax 25, VDmax 15, Method 1, and Method 2. Each of these methods consists of three steps:

  1. Bacteriostasis/Fungistasis (5 day test)
    1. Determines if the product contains inhibitory properties (e.g. antibiotics) or chemicals that can inhibit or mask the growth of microorganisms in the sample.
      • Refer to USP <71> for methods.
  2. Bioburden (12 day test)
    1. Determines population of viable organisms in the product in the form of colony forming units (CFU).
    2. Includes all components labeled sterile NOT just the product.
    3. Establishes the verification dose to achieve 10-2 SAL, based on tables provided in the standard.
  3. Sterilization Validation (14 day test)
    1. Samples are dosed at the verification dose and samples are tested for bioburden.
    2. Depending on the method, zero (0) samples or two (2) samples can test positive for the product to pass the validation.
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