Prepor PES
PREPOR PES is an innovative particulate grade membrane prefilter cartridge designed to work in harmony with final sterilizing filters, to guarantee the highest levels of performance and security. PREPOR PES combines high flow rate characteristics with good microbial reduction and minimum product adsorption by using the latest hydrophilic polyethersulphone membrane technology.
PREPOR PES uses all polypropylene hardware to offer good chemical compatibility and low extractables and is suitable for use in many pharmaceutical applications including:
- Terminal and aseptic filtration
- Ophthalmics
- Biologicals
- Serum
- SVPs (Small Volume Parenterals)
- LVPs (Large Volume Parenterals)
- Other complex liquids
Technical Specifications
Materials of Construction
- Filtration Membrane: Polyethersulphone
- Upstream Support: Polypropylene
- Downstream Support: Polypropylene
- Inner Support Core: Polypropylene
- Outer Protection Cage: Polypropylene
- End Caps: Polypropylene
- End Cap Insert (if applicable): 316L Stainless Steel*
*Not available in B & L endcap variants - Standard o-rings/gaskets: Silicone / EPDM
- Capsule Body: Polypropylene
- Capsule Vent Seals: Silicone
- Filling Bell: Polycarbonate
Food and Biological Safety
Materials conform to the relevant requirements of 21CFR Part 177, EC1935 / 2004 and current USP Plastics Class VI – 121 °C and ISO10993 equivalents.
Recommended Operating Conditions
Up to 70 °C (158 °F) continuous operating temperature and higher short-term temperatures during CIP to the following limits:
Capsules may be operated up to a temperature of 40 °C (104 °F) at line pressures up to 5.0 barg (72.51 psig) for liquids.
Effective Filtration Area (EFA)
10¨ (250 mm) Up to 0.69 m² (7.42 ft²)
Cleaning and Sterilization
PREPOR PES cartridges can be repeatedly steam sterilized in situ or autoclaved at up to 130 °C (266 °F). They can be sanitized with hot water at up to 90 °C (194 °F) and are compatible with a wide range of chemicals. Capsules can be repeatedly autoclaved up to 130 °C (266 °F).
To maximize the life of the cartridge, the differential pressure across the cartridge should not exceed 0.3 barg (4.35 psig) at 130 °C (266 °F).
Retention Characteristics
While the PREPOR PES product is rated for particulate retention, the performance of PREPOR PES products has been assessed to bacterial titre reduction using a challenge methodology based on the ASTM F838-05 methodology applied to sterilizing grade filters. Typical levels are given below:
Features and Benefits
- Micron rating from 0.04 to 0.8 micron
- Versatile particulate grade membrane filter for bioburden reduction and prefiltration duties
- High filtration area with asymmetrical membrane giving long life and high flow rates
- Available in a comprehensive range of end cap configurations for retrofitting existing applications