Nylon Membrane Cartridge, 0.65 Micron Rating, PNM-60
PNM grade Nylon cartridges are designed to be used as sterilizing grade cartridges for the pharmaceutical industry. The higher the quality nylon membrane utilized in these cartridges is optimized for retention so that it need not be double layered for extra security. Nylon cartridges see broad service in sterile fill applications in SVPs and as bio burden management filters in LVPs. Media and service liquid filtration are other common applications for this cartridge. Nylon is particularly suited for the filtration of solvents because of it's broad compatibility and low level of extractables.
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 Nylon
• Filtration Media Support: Polyester
• End Caps: Polypropylene
• Center Core: Polypropylene
• Outer Support Cage: Polypropylene
• Filtration Media: Dual Layered Nylon
• Filtration Media Support: Polyester
• End Caps: Polypropylene
• Center Core: Polypropylene
• Outer Support Cage: Polypropylene
• Sealing Method: Thermal Bonding
Dimensions
• Length: 5 to 40" (12.7 to 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
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
PNM 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.
PNM 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.
