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Purcise SLE Sterilizing-Grade Bricap L Series Capsule Filters

In stock
Part No. L02SSSLENA1QP
$180.00 USD
Capsule Format
Pore Size
Inlet/Outlet
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*Not for medical use

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
Filtration Area L02-0.12m²
L03-0.16m²
L05-0.28m²
L10-0.55m²
L20-1.1m²
L30-1.65m²
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.
What is the difference between nominal-rated membranes and absolute-rated membranes?

Nominal-rated membranes and absolute-rated membranes differ in manufacturing processes and materials. PP and GF membranes are nominal-rated and are typically used for clarification to remove visible particles, but they cannot be subjected to integrity testing. PES, PVDF, PTFE, and nylon are mostly absolute-rated membranes. They are generally used for bioburden reduction or sterile filtration of liquid and gas, with established standards for integrity testing.

How to define sterilizing-grade filters?

Sterilizing-grade filters are required to produce a sterile filtrate in a standard microbial challenge test (1 × 10⁷ CFU/cm² of Brevundimonas diminuta) and to establish a clear correlation with a practicable non-destructive physical integrity test. Such filters are commonly described as having a nominal pore size of 0.2/0.22 µm.

Can a 0.45 µm filter achieve complete sterilization?

A 0.45 µm absolute-rated filter can remove larger bacteria and microorganisms, with a removal efficiency of greater than 90%, and therefore can only be classified as a bioburden-reducing (or bacteria-reducing) filter. To achieve complete bacterial removal, a 0.22 µm absolute-rated filter is recommended.

What materials and filter formats are available for Cobetter sterilizing-grade filters?

Cobetter offers sterilizing-grade filters made from PES, PVDF, PTFE, and other membranes. The available formats include syringe filters, capsule filters in various sizes, and cartridge filters.

What are the advantages and benefits of Cobetter sterilizing-grade filters?

1. Gradient pore structure design, which enhances filtration flux and dirt-holding capacity.
2. Low extractables and leachables, with low protein binding.
3. Available in single-layer or composite membrane configurations.
4. Comprehensive product range and multiple connection options, suitable for a wide variety of application scenarios.