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Sterilization Validations


Applicable Standards

  • ISO
  • AAMI
  • ICH
  • ASTM

Services Summary

Nelson Labs offers a wide breadth of expertise in product sterilization validations across a broad range of technologies. With the combined resources and expertise of Nelson Labs and Sterigenics, our understanding of material compatibility, sterilization science, validation approaches and cycle optimization ensures customers have a reliable, defensible validation strategy.

Ethylene Oxide Sterilization Validation

An Ethylene Oxide (EO) Sterilization Validation is designed to assist the manufacturer in the development of a sterilization process that delivers the appropriate sterility assurance level and ensures repeatability for each product type developed. All types of products, whether sterilized in-house or by a contract sterilizer, must be validated to ensure compliance with national and international standards.

The requirements for an EO Sterilization Validation are outlined in ANSI/AAMI/ISO 11135. Various AAMI TIRs also offer guidance in meeting the requirements of the sterilization standard. Nelson Labs specializes in Ethylene Oxide Sterilization Validations, and we can partner with you as well as many contract sterilization facilities through the entire process from protocol generation to final report completion. See below for more details.

Radiation Sterilization Validation

Nelson Labs offers complete package testing and services in compliance with global regulatory requirements. 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 sublethal radiation dose (verification dose), test of sterility and bacteriostasis/fungistasis testing.

For ongoing process monitoring, Nelson Labs offers quarterly dose audit (QDA) coordination services that include dosing, testing, consulting and summary reports.

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 Labs 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.

Clinical Reprocessing Sterilization Validations and Functionality Studies

A sterilization validation test confirms the appropriate Sterility Assurance Level (SAL) of the medical device. The testing establishes the pertinent sterilization parameters for health care reprocessing instructions. Based on the data obtained through testing, the manufacturer will be able to provide health care facilities with validated sterilization parameters. Nelson Labs can validate using steam (gravity or prevacuum), ethylene oxide (EO), STERRAD®, or dry heat. For reusable instruments, liquid chemical or thermal disinfection may be acceptable alternatives.

In addition, manufacturers should validate end of life cycles for reusable or reprocessed medical devices to demonstrate functionality with repeated exposures and clinical simulations. Nelson Labs can assist in study design and execution of functionality and repeated use studies.

Clinical batch release studies can be performed on a limited basis for novel devices and products that require sterilization prior to receiving marketing approval.

ANSI/ASMI ST79, ANSI/AAMI ST77 and AAMI TIR12 are guidelines for testing reusable medical devices. Nelson Labs has the equipment and qualified personnel to help guide you through the process. Our experts will provide individualized consultation and are here to help simplify the complex regulatory and standard recommendations.

Sterilization Supplies

Process monitoring is an essential part of any sterilization validation and routine cycle verification. Nelson Labs offers a range of Process Challenge Devices (PCDs), Biological Indicator (BI) spore strips and discs for use in monitoring comparative resistance or ongoing cycle efficacy. We also offer product inoculation services to verify worst-case cycle efficacy.

Filter Sterilization Validations for Aseptic Processes

For pharmaceutical and liquid products that require sterile processing, Nelson Labs offers filter validation services to evaluate a filter’s ability to remove chemicals or microbial organisms of various sizes. This test allows manufacturers to determine membrane pore sizes and is an excellent lot release test in compliance with both the ASTM F838-05 and HIMA guidance documents.

If you have additional questions about Sterilization Validation testing, or would like to consult with the experts at Nelson Labs, just send us a requestor call us at +1 (801) 290-7500.