Polyethersulfone Membrane Cartridge, 0.65 Micron Rating, PPS-60
PPS grade Polyethersulfone cartridges are designed to be used as sterilizing grade cartridges for the pharmaceutical industry. The PPS membrane utilized in these cartridges is optimized for retention and are double layered for extra security. Polyethersulfone cartridges see broad service in sterile fill applications in SVP's and biological products. Polyethersulfone is particularly suited for the filtration of products whose constituents, such as preservatives, can adsorb to the media. The lower binding characteristics of Polyethersulfone make it a good choice for filtration of valuable protein solutions such as vaccines and other biologicals. PPS grade cartridges are 100% integrity tested.
Maximum Operating Parameters
• Micron Rating: 0.65 Micron
• Maximum Operating Temperature*: 180°F (82°C) at 10 psid in water
• Forward Differential Pressure: 50 psi (3.4 bar) at 20°C
• Reverse Differential Pressure: 40 psi (2.7 bar) at 20°C
• Recommended Changeout Pressure: 35 psid (2.4 psid)
Construction Materials
• Filtration Media: Dual Layered Polyethersulfone
• Filtration Media Support: Polypropylene
• End Caps: Polypropylene
• Center Core: Polypropylene
• Outer Support Cage: Polypropylene
• Filtration Media: Dual Layered Polyethersulfone
• Filtration Media Support: Polypropylene
• End Caps: Polypropylene
• Center Core: Polypropylene
• Outer Support Cage: Polypropylene
• Sealing Method: Thermal Bonding
Dimensions (Cylindrical)
• Length: 5 to 40" (12.7 101.6 cm) nominal
• Outside Diameter: 2.75" (7.0 cm) nominal
• Surface Area: 7.0 ft2 (0.65 m2) Per 10" length
Applications
Final Filtration of:
• Diagnostics • Vaccines
• LVp's & SVP's • Biologicals
• WFI Water • Medications
Flow Rate
The following table represents typical water flow at a one psi (69 mbar) pressure differential across a single 10 inch pleated cartridge element. The test fluid is water at ambient temperature. Extrapolation for housings with multiple elements and higher pressure drops is acceptable, but as flows increase the pressure drop of the housing becomes more apparent.
| Pore Size | 0.03 um | 0.10 um | 0.22 um | 0.45 um | 0.65 um |
| GPM | 1.1 | 1.8 | 3.2 | 5.0 | 6.0 |
| LPM | 4.16 | 6.81 | 12.11 | 18.92 | 22.71 |
USP Biosafety
The materials used to construct Pharmaceutical Grade filters are non-toxic and meet the requirements for the MEM Elution Cytotoxicity Test and USP24 Plastic Class VI 121°C Test.
FDA Compliance
The materials used to construct Pharmaceutical Grade filters meet the requirements listed by the FDA as appropriate for use in articles intended for repeated food contact as specified in Title 21 CFR sections 174.5, 177.1500, 177.1520, 177.1630, 177.2440 and 177.2600 as appropriate. PPS filters comply with Title 21 CFR sections 210.3 (b)(6) and 211.72 for non-fiber releasing filters.
The materials used to construct Pharmaceutical Grade filters meet the requirements listed by the FDA as appropriate for use in articles intended for repeated food contact as specified in Title 21 CFR sections 174.5, 177.1500, 177.1520, 177.1630, 177.2440 and 177.2600 as appropriate. PPS filters comply with Title 21 CFR sections 210.3 (b)(6) and 211.72 for non-fiber releasing filters.
Validation
PPS grade cartridges are validated using modified HIMA protocols at a challenge level of 107 organisms per cm2 of filter media. (0.22 um challenged with Brevundimonas diminutal) (0.45 um challenged with Serratia marscecens) (0.65 um challenged with Saccharomyces cerevisiae). Validation guide is available for 0.22 micron to meet regulatory requirements.
PPS grade cartridges are validated using modified HIMA protocols at a challenge level of 107 organisms per cm2 of filter media. (0.22 um challenged with Brevundimonas diminutal) (0.45 um challenged with Serratia marscecens) (0.65 um challenged with Saccharomyces cerevisiae). Validation guide is available for 0.22 micron to meet regulatory requirements.
Extractables
The levels of bacterial endotoxins in aqueous extracts from Pharmaceutical Grade Filters are below the USP24 limits defined in Water for Injection (<0.5 EU/ml). Pharmaceutical Grade filters typically exhibit low levels of non-volatile residues.
The levels of bacterial endotoxins in aqueous extracts from Pharmaceutical Grade Filters are below the USP24 limits defined in Water for Injection (<0.5 EU/ml). Pharmaceutical Grade filters typically exhibit low levels of non-volatile residues.
