Sterile Filter Validation
- Item No.:
- Sterile-Filter-Validation
Choose your Confidence® Validation Services
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
Brochure
Questions & Answers (9)
Yes, non-Sartorius products can be validated. However, this requires additional information about the filters and process to design appropriate validation protocols.
Filter validation tests and documents a filtration system's ability to consistently remove microorganisms, particles, or contaminants under specific conditions, ensuring product quality and efficacy.
Yes, Pre-Use Post-Sterilization Integrity Testing (PUPSIT) is recommended by EU GMP Annex 1 and can be part of filter validation. PUPSIT ensures the filter is intact and free from defects before use.
Filter validation includes bacterial retention tests, integrity tests, compatibility tests, extractables and leachables testing, and adsorption studies to ensure filter performance and product safety.
Single-use filters are for one-time use only. Reusable filters need extra validation to ensure performance after cleaning and sterilization for multiple uses.
Filter validation ensures product safety, sterility, regulatory compliance, reduces contamination risks, product loss, recalls, and assures consistent filtration during production.
Even with terminal sterilization, filter validation may be needed for in-process steps like bioburden reduction before filling, ensuring reliable filter performance.
You need to validate a filter when introducing it to production, changing process parameters, switching suppliers/models, implementing new products/processes, or during routine revalidation.
Yes, filter validation is mandated by FDA, EMA, and global bodies, detailed in FDA guidance, EU GMP Annex 1, and ISO standards. Non-compliance risks product approval.