Sterile Filter Validation
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.
- 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
- Bioburden reduction filter
- Sterilizing grade filter
- Virus filter (if needed)
- Air filter (on request)
- Bacterial challenge test & viability test
- Chemical compatibility test
- Product-specific integrity test
- Particle release test
- Adsorption test
- E&L testing
- Support with PUPSIT
Sartopore® Platinum is the high performance polyethersulfone (PES) filter platform from Sartorius Stedim Biotech. The innovative surface modification of the membrane leads to excellent wettability. Therefore, this filter family is perfectly suited for modern single-use applications, making processes highly economic, user friendly and safe. Using Sartopore® Platinum you will benefit from this cutting-edge membrane technology. For challenging processes, such as fill & finish, we offer a special filter type with an increased Bubble Point: Sartopore® Platinum HB.
Sartobran® P with its unique cellulose acetate (CA) membrane is mainly used for the sterile filtration of blood & plasma products as well as viral vaccines. The ultra-low binding feature of the membrane material leads to highest product yield. Especially large, shear-stress sensitive proteins do not lose their structure and function when filtered through this special membrane. This will improve your process output even further.
Sartopore® 2 is the industry standard of high-performance polyethersulfone (PES) liquid filters. A broad variety of different pore size combinations ensures highly economic and safe filtration performance. From single-layer high flow solutions to specific Mycoplasma retentive filters, Sartopore®2 perfectly adapts to your specific process needs.
Sartolon filters are designed for broad chemical compatibility for specific applications in the pharmaceutical and chemical industry. The double-layer design leads to superior filtration performance compared to other nylon membrane filters and thereby allows more economical design of your filtration process. Sartolon filter elements are ideal for filtration of a broad range of solvents and solvent-containing liquids as well as oily formulations.