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Purcise SLE Sterilizing-Grade Bricap T Series Capsule Filters

In stock
Part No. T10SSSSLENA1QP
Capsule Format
Pore Size
Inlet/Outlet

Polyethersulfone (PES) material, optimal filter for final filtration.

Specifications

Materials Membrane Hydrophilic Polyethersulfone(PES)
Support Polypropylene(PP)
Core/Cage/End Cap Polypropylene(PP)
Capsule Housing Polypropylene(PP)
Capsule Vent O-rings Silicone
Gauge Port Type 38 mm (1 1/2") Sanitary Flange;
19 mm (3/4") Sanitary Flange;
Without Gauge Port
Filtration Area T10-0.55m²
T20-1.1m²
T30-1.65m²
Operating Conditions Max. Operating Temperature 80°C
Max. Differential Pressure (Forward) 0.55 MPa @25°C
0.10 MPa @80°C
Max. Differential Pressure (Reverse) 0.21 MPa @25°C
Quality Standards Integrity 100% Integrity testing
Traceability Each filter with a unique serial number
QMS ISO 9001:2015
Sterility Delivery Condition Non-sterile
Sterilization Method Can be autoclaved 25 cycles for 30 minutes at 130°C (Can not be steam sterilized in-line)
Package Pack Size 1/pk
Packaging Double PE bag

*Note: Cobetter also provides filters with different sterilization methods:

1. Gamma compatible filters: can be sterilized by gamma irradiation at 25-45 kGy or can be autoclaved 5 cycles for 60 minutes at 126 °C. (Can not be steamed in-line);
2. Pre-sterilized filters by gamma irradiation at 25-45 kGy (Gamma-sterilized products cannot be re-sterilized with gamma irradiation or steam sterilization);
3. Pre-sterilized filters by autoclaved for 30 minutes at 121°C (Packed in sterile breathable bags).

Features

  • Low adsorption and low leachables
  • Unwetted filter can be steam sterilized directly

Applications

  • Sterile filtration of terminal products
  • Sterile filtration of biological products
  • Blood and serum products
  • Sterile filtration of vaccine products
  • Pre-column/ultra-filtration protection
  • Filtration of intermediate products/stock solutions

Regulatory Compliance

  • Effluent meets the USP<788> requirement of particulate matter in large volume injection.
  • Component materials meet the criteria for a “Non-fiber-releasing filter”as defined in 21 CFR 210.3(b)(6).
  • Retention of 10⁷ cfu/cm² Brevundimonas diminuta(ATCC 19146) according to ASTM F838.
  • Aqueous extraction from a cartridge contains less than 0.25EU/ml as determined by Limulus Amebocyte Lysate (LAL), meeting requirements of USP<85>.
  • Components meet the requirement of USP <87> In Vitro Biological Reactivity Test.
  • Components meet the criteria of the USP <88> Biological Reactivity Test for Class V-121 °C plastics.
  • Components meet the FDA indirect Food Additive requirements cited in 21 CFR177-182.
  • Based on the current information from our suppliers, all components used in the manufacture of this product are animal-free.


*Contact us for more specification details.