Sterilization Validation

Sterilization Validation

LexaMed has extensive experience in developing and validating steam sterilization processes for medical device and pharmaceutical products.  LexaMed associates are active members of the AAMI Moist Heat Sterilization Working Group (ST/WG 03) and Resistometer Working Group (ST/WG 91).  LexaMed is ISO 13485 certified, ISO 17025 accredited, holds State of Ohio and federal drug licenses and DEA registrations, and maintains FDA registered laboratories for both medical devices and pharmaceuticals testing.  LexaMed offers a full complement of microbiology and chemistry services in our corporate laboratories located in Toledo, Ohio.

LexaMed maintains two qualified vacuum steam autoclaves that can be used to validate sterilization processes for reusable devices in a clinical setting.  When combined with a cleaning validation, the steam sterilization validation provides the manufacturer with a robust data package to support a sterile claim for their reusable device.  Sterilization validations are conducted per ISO 17665, ANSI/AAMI ST79, AAMI TIR12 and PDA TIR 1.  The overkill approach is typically recommended with regard to heat stable components and devices, and the process temperature can be specified from 121 °C to 135 °C.  Prior to execution of the validation, LexaMed’s experts can assess the design of the devices and final product packaging to provide justifications for biological indicator (BI) challenge locations, load configurations, and packaging materials.  Development and Validation services also consist of the following:

  • Consulting and technical services
  • Protocol development
  • BI qualification studies
  • Cycle execution (in house or client site)
  • BI and chemical indicator (CI) testing
  • Product drying assessment
  • Final reporting
  • Quality systems and regulatory support

LexaMed has industry leaders that can assist you in the development and validation of steam sterilization processes for parenteral drug products and manufacturing materials.  LexaMed offers a full range of on-site support and laboratory testing for installation and operational qualifications, as well as sterilization process performance qualification.  The sterilization process validation follows ISO 17665 and can proceed by three approaches: bioburden based, combined BI-bioburden base, or BI-overkill approach.  LexaMed can provide customers with the guidance to choose the correct approach based on the characteristics of the product and the business needs of the customer. 

If you would like to discuss your project with one of our experts, please fill out our contact form, and we will be with you immediately.