ZTEC P Cartridges

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ZTEC P Sterilizing Grade membrane cartridges are HIMA validated for complete bacterial retention to yield product sterility in biopharmaceutical final filtration applications. The naturally hydrophilic and low protein binding characteristics of Polyethersulfone membrane ensure maximum transmission of active ingredients making it ideal for a wide range of pharmaceutical and biological liquid applications, inculding the filtration of therapeutics, vaccines, antibiotics, bulk pharmaceutical and other critical biotechnology products. The double-layer PES 0.2 micron membrane filters are manufactured in a cleanroom environment, and integrity tested before shipment to assume consistent performance and quality.

 

Features:

• Manufactured in ISO Class 7 Cleanroom Environment
• 100% flushed with ultrapure DI water
• Meets ASTM Standards for Sterility
• Repeatably Steamable/Sanitizable
• 100% Integrity tested prior to release
• Pore size, lot and serial number are stamped on each filter element for identification and traceability

 

Performance Specifications:

Hot DI Water
Filter Cartridge will withstand temperatures of 185°F (85°C) for up to 30 consecutive minutes.

Cleaning/Sanitization
Compatible with most common chemical cleaning, sanitizing and sterilizing agents and witht he pH range from 1-14. Consult factor for specific compatibility information.

Steam/Autoclave

Cartridges may be steamed or autoclaved for at least 50 thirty minute cycles at 275°F (135°C)

Typical Bacterial Retention Performance

Cartridges have been validated for teh complete retention of Brevundimonas diminuta at a challenge level of 10­^7 organisms/cm² as prescribed in ASTM 838-05.

Integrity Test Specifications
Minimum Bublle Point values and maximum Diffusive Air Flow (per 10 inch cartridge) values for ZTeC-P filters wet with water:


Applications:

• Diagnostics
• Ophthalmic Solutions
• Culture Media
• Reagent Chemicals
• LVPs
• Buffers
• Vaccines

 

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