Sterilization validation services
Comprehensive sterilization validation process and testing facilities
As the sterilization experts STERIS have specific knowledge of performing sterilization validation (ISO 11137) to determine radiation doses
A radiation sterilization validation (ISO 11137) determines the minimum appropriate radiation dose for a product that requires a sterile label claim.
Sterilization validation can be completed using one of two methods
Method 1 or VDMax which both incorporate bioburden testing, a bioburden recovery efficiency test, a sub-lethal radiation dose (verification dose), test of sterility and bacteriostasis/fungistasis (B&F) test as shown in the flow paths below. (which flow paths?)
Following the sterilization validation, the effectiveness of the radiation dose is monitored by completing quarterly dose audits. This incorporates bioburden testing, the reapplication of the verification dose and a test of sterility.
STERIS Pharmaceutical Laboratories can offer:
- A complete service package from initial microbiological method development, verification dose to final sterility testing. The complete sterilization validation is detailed in one report along with the irradiation certificate
- A range of expertise covering the microbiological testing as well as the process sterilization, ensuring our Customers achieve a tailored product/device sterilization solution
- Vast experience providing sterilization validations for complex or unique products.
- Experience and guidance for products which are sensitive to irradiation and may require lower irradiation doses
- Controlled testing documentation issued to customer for every sterilisation validation completed, ensuring consistency in sterilisation dose audit testing throughout product/device life span
- Testing lead times available to suit product submission timelines
- Continuous support, consultancy and updates within the sterilization validation process
Industries and products suitable for sterilization validations
CE marked products or products claiming to be sterile.
ISO 13485, ISO 11137, ISO/TS 13004, AAMI TIR 33, ISO 11737