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.
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
Applications: Materials Acceptance; Process Evaluation; Sterilization Validation; Change Control; Environmental Monitoring (microbial sampling, microbial identification, clean room validation)
Applications: Component Screening; Sterilization Validation; Aseptic Process Validation; Lot Release
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
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.
Materials characterization (chemistry) studies specific to your product are also available.