Cytiva(思拓凡)生命科学与生物制药

HDC II membrane in Kleenpak™ Nova capsules

Proprietary tapered-pore polypropylene depth media

The HDC II membrane in Kleenpak™ Nova capsules, a Pall Life Sciences product, are constructed with polypropylene for medium to large scaled productions. Capsules are available in T-style or In-line inlet/outlet configurations. Pall seeks to fit seamlessly into any biologics handling and biopharmaceutical production. Capsules accommodate a wide range of high capacity filter media and provide a long service life.

HDC II all-polypropylene filters incorporate proprietary tapered-pore polypropylene depth media. With removal ratings from 0.6 micron to 700 micron, HDC II filters are well-suited to a broad range of prefiltration applications in biological and chemical API manufacturing facilities where purity, economy and reliability are critical.

Kleenpak Nova capsules are designed for use in medium-to-large-scale production environments (100 L to > 1000 L), and are often selected by the end user following scaling studies using smaller, Kleenpak capsule formats. Kleenpak Nova capsules can be offered with ‘In-line’ (NP) or ‘T’ style (NT) inlet/outlet configurations with sanitary flange or hose barb fittings. With the AB-style filter cartridge at their core, Kleenpak Nova filter capsules can be supplied with the most comprehensive range of filter media among all of Pall’s single-use capsules.

Features and Benefits

All-polypropylene construction
High-capacity filter media for long-life
Fixed pore, non-shedding for consistent performance
Low binding for maximum transmission of proteins
Low extractables for premium product quality
Broad chemical compatibilities for use in a wide range of applications
Available in T-style or in-line formats for flexibilty of use
Staubli vent valve allows for simplicity of connection to integrity test devices
Resistant to repeat autoclave cycles
Variable inlet and outlet connection configurations to accept variable tubing dimensions
Quality and Bio-Safety Biological Tests
Meets USP Biological Reactivity Test in vivo for Class VI-121°C Plastics

Effluent Quality Tests*

Meets Cleanliness per USP Particulates in Injectables
Non-Fiber-Releasing Non-Pyrogenic per USP
Bacterial Endotoxins (< 0.25 EU/mL)
Meets Total Organic Carbon and Water Conductivity per USP Purified Water, pH per USP Sterile Purified Water
* Per lot sample soak or rinse-up flush aliquots

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