Sterile Filter Validation
Confidence® sterile filter validation includes physicochemical, microbiological, and E&L testing for all bioburden reduction or sterilizing grade filters.
- Item No.:
- Sterile-Filter-Validation
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*Custom/bulk order quotes are provided within 72 hours of request.
Choose your Confidence® Validation Services
Our validation experts work to ensure regulatory acceptance by planning and defining the test scope carefully. The validation tests, analysis and documentation of the validation data are based on regulatory guidelines, such as PDA TR26 and ASTM F838.
Benefits
- Proven Experience: Based on more than 25 years of active service
- Expertise: Complex filtration set ups can be handled from buffer studies to testing with cytotoxic products
- Personalized Support: Our Confidence® experts guide through the entire validation process, from the first meeting to the successful completion of the project
- One Single Point of Contact: Our project managers facilitate a more efficient validation project workflow by managing internal and external stakeholders
Applications
- Bioburden reduction filter
- Pre-filter
- Sterilizing grade filter
- Virus filter (if needed)
- Air filter (on request)
Services
- Bacterial challenge test & viability test
- Chemical compatibility test
- Product-specific integrity test
- Particle release test
- Adsorption test
- E&L testing
- Support with PUPSIT