PTFE Membrane Cartridge, 1.0 Micron Rating, PTM1-0, Pharmaceutical Grade

PTM sterilizing grade cartridge filters are manufactured for the specific needs of the pharmaceutical industry. Manufactured with inherently hydrophobic PTFE membrane, these cartridges are designed for use in the filtration of aggressive solvents, and as compressed gas and vent filters. Each cartridge module is individually bubble point tested using 60/40 IP and water before it is released from manufacture. The cartridge surface area, filter core design, pleat configuration and pleat packing density have been optimized to provide increased cartridge life resulting in lower filtration operating costs. Rugged construction ensures repeatable steaming and testing. PTM grade cartridges are 100% integrity tested.

Maximum Operating Parameters

• Micron Rating: 1.0 Micron
• Forward Differential Pressure: 50 psi (3.4 bar) at 20°C
• Reverse Differential Pressure: 40 psi (2.7 bar) at 20°C

Dimensions (Cylindrical)

• Length: 5 to 40" (12.7 101.6 cm) nominal
• Outside Diameter: 2.75" (7.0 cm) nominal
• Surface Area: 8.2 ft² (0.65 m²) Per 10" length

Applications
Final Filtration of:

• Compressed Air                      • Pressurized Gases
• Fermentation Air                     • Tank Ventilation
• Solvents                              


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.

Validation
PTM 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) 

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.