BioDoer™ PA Series Bio-Reduction Grade Nylon Pleated Filter Cartridges
BioDoer™ PA Series nylon pleated filter cartridges provide highly efficient micronic and submicronic retention of particulates and microbial bio-burden in the production of pharmaceutical and biotechnology fluids. The nylon mem...
BioDoer™ PA Series nylon pleated filter cartridges provide highly efficient micronic and submicronic retention of particulates and microbial bio-burden in the production of pharmaceutical and biotechnology fluids. The nylon membrane offers durability with fine permeability and contaminant capacity. Excellent microbial retention with proven high LRV performance. The naturally hydrophilic membrane allows for fast and easy wetting in aqueous fluids. Cartridges receive a thorough ultrapure water rinse to assure product cleanliness. Cartridges are 100% integrity tested to assure optimized retention performance.
Features
Durable nylon membrane and polypropylene components
Naturally hydrophilic for fast & easy wetting
Positive Zeta potential surface charge option improves retention of haze, colloids, and endotoxins
Component materials comply with US FDA and EU regulations for safe use with food and potable water
Applications
Large volume parenterals (LVPs)
Small volume parenterals (SVPs)
Active pharmaceutical ingredients (APIs)
Ophthalmic solutions
Biologicals: vaccine & blood products
Buffers & reagents
Product Quality
Individual elements are identified by serial number.
Produced in a clean-room environment for product purity & cleanliness.
Manufactured within an ISO 9001:2015 certified quality management system.
Each element is integrity tested by diffusion flow.
A Certificate of Quality document is provided with each production lot.
Microbial Retention Performance
Rating
Microbial Retention
0.2μm
Brevundimonas diminuta (ATCC 19746), 7-8 LRV
0.45μm
Serratia marcescens (ATCC 14756), 6-7 LRV
0.65μm
Saccharomyces cerevisiae, 5-6 LRV
See Product Performance & Operating Guide for additional information, including integrity test parameters & methodology recommendations
Materials of Construction
Media:
Nylon 66
Support Layers:
Polypropylene
Cage/Core/End Caps:
Polypropylene
Adapter Reinforcement:
Stainless steel or polysulfone
Seal Options:
Silicone, NBR, EPDM, FKM, E-FKM
Dimensions
Diameter:
69mm (2.72")
Lengths:
10”, 20”, 30”, 40”
Operating Conditions
Operating Temperature:
80°C (176°F) max.
Operating dP (max.):
4 bar (58 psi) @ 20°C (68°F) 2 bar (29 psi) @ 80°C (176°F)
Sterilization Recommendations
Autoclave
125°C (257°F), 30 minutes, 30 cycles
Steam-in-Place (SIP):
125°C (257°F), 30 minutes, 30 cycles
Extractables, typical
Per 10” element:
﹤20mg non-dissolved solids
Clean Pressure Drop
Effluent Quality
Non-fiber releasing
High LRV performance provides increased microbial stability to prevent spoilage.
Non-pyrogenic per USP Bacterial Endotoxin Requirements (>0.25EU/mL)
Effluent meets USP Purified Water requirements for TOC, pH, and water conductivity
