PharmaDoer™ PES-PH Series Sterilizing Grade Sequentially-Layered PES Pleated Filter Cartridges

PharmaDoer™ PES-PH Series Sterilizing Grade Sequentially-Layered PES Pleated Filter Cartridges

PharmaDoer™ PES-PH Series polyethersulfone (PES) pleated filter cartridges provide highly efficient micronic and submicronic retention of particulates and can deliver fully retentive sterilizing performance for microbial bio-bu...

PharmaDoer™ PES-PH Series polyethersulfone (PES) pleated filter cartridges provide highly efficient micronic and submicronic retention of particulates and can deliver fully retentive sterilizing performance for microbial bio-burden in the production of pharmaceutical and biotechnology fluids. The sequentially-layered highly asymmetric PES membrane offers fine permeability and contaminant capacity. The 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 by forward flow diffusion to assure optimized retention performance.

Features

  • Durable sequentially-layered PES and polypropylene components
  • Validation Guide is available for 0020S fully retentive grade
  • Extreme porosity highly asymmetric membrane
  • Excellent fluid compatibility
  • UPW rinse assures low extractables

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

RatingMicrobial Retention
0.2μmBrevundimonas diminuta(ATCC 19746), fully retentive
0.45μmSerratia marcescens (ATCC 14756), >7 LRV
0.65μmSaccharomyces cerevisiae, >7 LRV
See Product Performance & Operating Guide for additional information, including integrity test parameters & methodology recommendations

Materials of Construction

Media:Polyethersulfone
Support Layers:Polypropylene
Cage/Core/End Caps:Polypropylene
Adapter Reinforcement:Polysulfone or Stainless Steel
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)
Change-Out dP:2.6 bar (38 psi) @ 20°C (68°F)
Sterilization Recommendations
Autoclave125°C (257°F), 30 minutes, 30 cycles
Steam-in-Place (SIP):125°C (257°F), 30 minutes, 30 cycles
Extractables, typical
Per 10” element:﹤25mg non-dissolved solids

Clean Pressure Drop

Effluent Quality

  • Non-fiber releasing
  • 0.45/0.20μm grade delivers sterile effluent in
  • accordance with the requirements of ASTM838-20.
  • High LRV or full sterility performance for effluent with 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

Ordering Information