U.S. Biologics, Advanced Therapies & Medical Devices Manufacturing and Testing

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 commercialization. We provide a comprehensive menu of services and expert assistance with your testing strategy to help ensure requirements are met for worldwide regulatory submissions.

Microbiology Services
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.

Characterization / Identification of Microorganisms

Gram stains, spore stains, colony morphology, cellular morphology; Biochemical tests; Genotypic identifications

Bioburden Testing

Applications: Materials Acceptance; Process Evaluation; Sterilization Validation; Change Control; Environmental Monitoring (microbial sampling, microbial identification, clean room validation)

Sterility Testing

Applications: Component Screening; Sterilization Validation; Aseptic Process Validation; Lot Release

Endotoxin Testing

Applications: Materials Screening; Process Validation; Lot Release

Microbial Assays and Custom Cleaning Efficacy Studies

Applications: Antimicrobial Effectiveness; Biofilm Evaluation; Cleaning / Disinfection / Sterilization Efficacy Validations for Reprocessing and Re-sterilization; Microbial Identification; USP Microbial Examination; Radiation Validation

Package Testing

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, transportation/simulated distribution, and shelf life/stability determination.

Chemistry Testing

Materials characterization (chemistry) studies specific to your product are also available.