Microbiology & Package Testing
With unparalleled expertise and experience, WuXi AppTec can guide you in the development of your critical testing programs as you navigate your product from development to delivery. We provide a comprehensive menu of services and expert assistance with your testing strategy to help ensure requirements are met for worldwide regulatory submissions.
Our full range of microbiology services provides testing across the product development life cycle and beyond: R&D and screening, in-process release and validations, and finished product delivery.
Applications: Materials Acceptance; Process Evaluation;
Sterilization Validation; Change Control; Environmental Monitoring
Applications: Component Screening; Sterilization Validation;
Aseptic Process Validation; Lot Release
Applications: Materials Screening; Process Validation; Lot Release
Microbial Assays and Custom Efficacy Studies
Applications: Antimicrobial Effectiveness; Biofilm Evaluation; Cleaning / Disinfection / Sterilization Efficacy
Validations for Reusable Device Cleaning and Re-sterilization
Our ISTA-certified laboratory provides manufacturers with an array of testing services for their
packaging systems. Testing services can be used to demonstrate compliance with the requirements cited in ANSI/AAMI ISO 11607, Packaging for terminally sterilized medical devices – Part 1 and Part 2. Services feature packaging system design qualification testing and Sterile Barrier System (SBS) testing, including accelerated aging, package/seal integrity, simulated distribution, and shelf life/stability determination.
Materials characterization (chemistry) studies specific to your product are also available. Click here for more information on materials characterization.
For more details on available testing services, click here to access the Catalog of Services for Devices and Combination Products OR click here to access a collection of PDF literature available for viewing and printing.