For sterilization of aqueous liquids.
SPS Filters provide a wide selection of validated, single layer Polyethersulfone (PES) cartridge and capsule filters used for the sterilizing of aqueous liquids. Pore sizes range from 0.03 to 1.2 μm and the filter sizes scale from laboratory to full production using identical materials to ensure consistent results.
The hydrophilic SPS filters have low binding characteristics that are ideal for filtering products with preservatives and high protein solutions that can adsorb to media. SPS filters deliver high flow and throughput with compatibility across a wide pH range.
SPS filters are flushed to remove manufacturing debris and reduce extractables. Products are 100% integrity tested. SPS capsules are available pre-sterilized.
Applications
- Diagnostics
- SVPs & LVPs
- Water for Injection
- Water Purification
- Buffers
- Biologicals
- Vaccines
- Ophthalmics
Features and Benefits
SPS is a family of single-layer pharmaceutical grade, Polyethersulfone (PES) sterilizing filters.
- Delivers high flow across a wide pH range
- Low binding characteristics (much lower than cellulose acetate and nylon) for filtering liquids with preservatives and proteins that can adsorb to media
Filtration Area
Validation
SPS filters are validated using test procedures that comply with ASTM F 838-15(ae1) protocols for the determination of bacterial retention in filters used for liquid filtration. The challenge level is a minimum of 107 organisms per cm2 of filter media. CPF filters have > 7-log removal when challenged with the organisms listed below (0.03μm, 0.10μm and 0.22μm meet the FDA definition of sterilizing grade filters). Validation Guides are available upon request.
- 0.03μm: Acholeplasma laidlawii
- 0.10μm: Brevundimonas diminuta
- 0.22μm: Brevundimonas diminuta
- 0.45μm: Serratia marcescens
- 0.65μm: Saccharomyces cerevisiae
Quality Assurance
SPS filters are 100% integrity tested. CPF filters are developed and manufactured under an ISO 9001:2015 certified Quality Management System and designed to be used in cGMP-compliant processes.
SPS Cartridges
Available from 5-40 inches in length with several end connections and O-ring options. SPS/HT Cartridges can be used in processes up to 203°F.
SPS Capsules
These filters are SPS cartridges encapsulated in a polypropylene shell to minimize exposure to process fluids. A popular choice for single-use applications and can be disposed of easily. Sizes range from 2-30 inches in length. SPS Capsules are available pre-sterilized.
SPS Mini-Capsule
Mini-capsules are designed for lab scale testing, process development and small batch production with a filtration area of 500 cm2. SPS Mini-Capsules are available pre-sterilized.
View Data Sheet for further product information:
- Integrity test specifications
- Flow rates for all pore sizes
- Materials of construction
- Operating parameters
- Sanitization and sterilization
- Regulation & compliance