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Radiation Sterilization Validation

Radiation Sterilization Validation

A radiation sterilization validation determines the appropriate radiation sterilization dose for a product that requires a sterile label claim. It incorporates bioburden testing, a bioburden recovery efficiency test, a sub-lethal radiation dose (verification dose), test of sterility and bacteriostasis/fungistasis testing.

If a sterile label claim is required and the sterilization method will be radiation, a validation is required to determine the appropriate sterilization dose. Nelson Laboratories has vast experience providing validations for complex or unique products, or products which cannot handle large doses of radiation. The testing complies with the radiation sterilization standard ANSI/AAMI/ISO 11137 and technical specification ANSI/AAMI/ISO 13004.

Applicable Standards

  • ANSI/AAMI/ISO 11137
  • ANSI/AAMI/ISO 13004

Test Options

Ask an expert for a specific consultation on your product. If you are ready to submit your samples for testing, click here to fill out the Sample Submission Form.

Code Test Request Quote
SVR110 Radiation Sterilization: AAMI VDmax Single Lot Validation Add
SVR120 Radiation Sterilization: AAMI VDmax 3 Lot Validation for Lot Release Add
SVR125 Radiation Sterilization (Tissue): AAMI VDmax Validation, filtration, 3 donors Add
SVR126 Radiation Sterilization (Tissue): AAMI VDmax Validation, MPN, 3 donors Add
SVR130 Radiation Sterilization: AAMI VDmax Dose Audit - <1L Add
SVR135 Radiation Sterilization: AAMI VDmax Dose Audit - >1L Add
SVR140 Radiation Sterilization: AAMI VDmax Dose Audit - <1L & MPN Add
SVR145 Radiation Sterilization: AAMI VDmax Dose Audit - >1L & MPN Add
SVR210 Radiation Sterilization: AAMI Method 1 Validation Add
SVR220 Radiation Sterilization: AAMI Method 1 Dose Audit - <1L Add
SVR225 Radiation Sterilization: AAMI Method 1 Dose Audit - >1L Add
SVR310 Radiation Sterilization: AAMI Method 2 Validation Add
SVR320 Radiation Sterilization: AAMI Method 2 Dose Audit <1L Add
SVR325 Radiation Sterilization: AAMI Method 2 Dose Audit >1L Add
SVR610 Radiation Sterilization: Bioburden - add. spores or anaerobes Add
SVR705 Radiation Pooling Fee, per pooled unit (per device, plus cost of test) Add
SVR710 Radiation Sterilization: Gamma Dosing Charges - Sterigenics (std) Add
SVR711 Radiation Sterilization: E-Beam Dosing Charges - Sterigenics (std) Add
SVR715 Radiation Pooling Fee, per pooled set/kit/pkg (plus cost of test) Add
SVR910 Radiation - Extraction efficiency, exhaustive rinse method, per unit Add
SVR920 Radiation - Extraction efficiency, inoculated product method, per unit Add
SVR110 - Radiation Sterilization: AAMI VDmax Single Lot Validation
SVR120 - Radiation Sterilization: AAMI VDmax 3 Lot Validation for Lot Release
SVR125 - Radiation Sterilization (Tissue): AAMI VDmax Validation, filtration, 3 donors
SVR126 - Radiation Sterilization (Tissue): AAMI VDmax Validation, MPN, 3 donors
SVR130 - Radiation Sterilization: AAMI VDmax Dose Audit - <1L
SVR135 - Radiation Sterilization: AAMI VDmax Dose Audit - >1L
SVR140 - Radiation Sterilization: AAMI VDmax Dose Audit - <1L & MPN
SVR145 - Radiation Sterilization: AAMI VDmax Dose Audit - >1L & MPN
SVR210 - Radiation Sterilization: AAMI Method 1 Validation
SVR220 - Radiation Sterilization: AAMI Method 1 Dose Audit - <1L
SVR225 - Radiation Sterilization: AAMI Method 1 Dose Audit - >1L
SVR310 - Radiation Sterilization: AAMI Method 2 Validation
SVR320 - Radiation Sterilization: AAMI Method 2 Dose Audit <1L
SVR325 - Radiation Sterilization: AAMI Method 2 Dose Audit >1L
SVR610 - Radiation Sterilization: Bioburden - add. spores or anaerobes
SVR705 - Radiation Pooling Fee, per pooled unit (per device, plus cost of test)
SVR710 - Radiation Sterilization: Gamma Dosing Charges - Sterigenics (std)
SVR711 - Radiation Sterilization: E-Beam Dosing Charges - Sterigenics (std)
SVR715 - Radiation Pooling Fee, per pooled set/kit/pkg (plus cost of test)
SVR910 - Radiation - Extraction efficiency, exhaustive rinse method, per unit
SVR920 - Radiation - Extraction efficiency, inoculated product method, per unit

Sample Specifications

SVR110: 26 samples
SVR120: 46 samples
SVR130: 20 samples
SVR135: 20 samples
SVR210: 136 samples
SVR220: 110 samples
SVR225: 110 samples
SVR310: 596 samples
SVR325: 110 samples

Study Outline

A radiation sterilization validation is used to determine the appropriate sterilization dose for a product. Usually the sterilization dose must represent a sterility assurance level (SAL) of 10-6, which is a one in one million probability of a non-sterile product. The most common validation methods are VDmax (short for Verification Dose Maximum) and Method 1.

VDmax and Method 1
Both of these methods are available in a single batch validation format (for clinical trials) or a full 3-batch validation. These radiation validations consist of three main phases:

  1.  Bioburden test: This test determines the quantity of viable microorganisms on or in the product. This test is performed prior to any sterilization but after all other manufacturing steps, including packaging. Critical to this test is the performance of a recovery efficiency test to determine the effectiveness of the bioburden extraction method at removing microorganisms from the product.  Other options for performing bioburden are available and may be more appropriate for certain product types.
  2. Application of verification dose: The bioburden results are taken to a table from the standard to determine the proper verification dose. The verification dose is then applied to the required number of products. Samples should be double bagged prior to dosing. This provides an extra barrier to take into the cleanroom and can reduce the potential for false positives.
  3. Sterility test: The irradiated products undergo a test of sterility. The acceptance criteria for each method are detailed in ANSI/AAMI/ISO 11137-2. Critical to this test is the performance of a bacteriostasis/fungistasis test to demonstrate the lack of inhibition in the sterility test system and is required to validate the test of sterility.
     
If the number of non-sterile samples in the test of sterility meets the acceptance criteria, the radiation sterilization dose is validated. Additional testing should be performed on a quarterly basis (called a quarterly dose audit) to demonstrate that the sterilization dose continues to be appropriate for the product. The quarterly dose audits follow the same flow as described above, but only involve samples from a single batch, and include use of the verification dose determined in the validation rather than setting a new one.

Method 2
A less frequently used validation method is Method 2 (available as either Method 2A or 2B). This method is used when it is critical to validate the lowest sterilization dose possible for a product, usually because the product is sensitive to radiation. Options for reducing the number of incremental doses required for a Method 2 can be found in AAMI TIR 40.

Requirements of radiation validations and quarterly dose audits are provided in the ANSI/AAMI/ISO 11137 standard series.

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