A Radiation Sterilization Validation determines the appropriate radiation sterilization dose for a product that requires a sterile label request. The bioburden test includes a bioburden recovery efficiency test, a sublethal radiation dose (confirmatory dose), sterility test, and bacteriostasis / fungiis test.
If a sterile label claim is required and the sterilization method will be radiation, a validation is required to determine the appropriate sterilization dose. EUROLABhas extensive experience providing validation for complex or unique products or products that cannot handle high doses of radiation. The test complies with radiation sterilization standard ANSI/AAMI/ISO 11137 and technical specification ANSI/AAMI/ISO 13004.
A radiation sterilization validation is used to determine the appropriate sterilization dose for a product. The sterilization dose should represent 1-10 sterility assurance levels (SAL), which is usually one of 6 million possibilities of a non-sterile product. The most common verification methods are VDmax (Maximum Verification Dose) and Method 1.
VDmax and Method 1
Both of these methods can be used in single-lot validation (for clinical trials) or full three-lot validation. These radiation verifications consist of three main stages:
1. Biological load test: This test determines the quantity of live microorganisms on or in the product. This test is performed before any sterilization, but after all other production stages, including packaging. Critical to this test is conducting a recovery efficiency test to determine the effectiveness of the biological load extraction method in removing microorganisms from the product. Other options for performing biological load testing are also available and may be more suitable for certain product types.
2. Application of the confirmation dose: Biological load results are plotted against a standard table to determine the correct confirmation dose. The confirmation dose is then applied to the required number of samples. Samples should be double-bagged before dosing. This provides an extra barrier to entering the cleanroom and can reduce the potential for false positives.
3. Sterility test: Irradiated products undergo sterility testing. Acceptance criteria for each method are detailed in ANSI/AAMI/ISO 11137-2. Critical for this test is the performance of a bacteriostasis/fungistasis test to demonstrate a lack of inhibition in the sterility test system, which is necessary to validate the sterility test.
If the number of non-sterile samples in the sterility test meets the acceptance criteria, the radiation sterilization dose is validated. Additional testing should be performed every three months (called a quarterly dose check) to demonstrate that the sterilization dose remains suitable for the product. The quarterly dose checks follow the same flow as described above, but only contain samples from a single batch and include the use of the validation dose determined in the validation rather than replacing a new one.
Method 2
A less used verification method is Method 2 (can be used as Method 2A or 2B). This method is used when it is critical to verify the lowest possible sterilization dose for a product, usually because the product is radiation sensitive. Options to reduce the number of incremental doses required for method 2 can be found in the AAMI TIR40.
The requirements for radiation validations and quarterly dose audits are presented in the ANSI / AAMI / ISO 11137 standard series.
EUROLAB, with its highly expert team and internationally accredited laboratories, Radiation Sterilization Validation Test It performs all test, analysis, measurement, evaluation and report generation services completely and reliably.
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