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Sterilizing-Grade Membrane Filters
Sterilizing-Grade Membrane Filters
- Description: Used for final filtration of sterile drugs and biologicals.
- Applications: Vaccine filtration, media sterilization, WFI filtration, API bulk filling.
- Formats: Cartridge (10”, 20”), capsule, disc.
- Materials: PES, PVDF, PTFE, Nylon 66.
- Pore Sizes: 0.1 μm, 0.2 μm, 0.22 μm.
- Compliance: USP , , FDA 21 CFR, cGMP.
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SOP (Summary):
1. Assemble in ISO Class 7 environment.
2. Integrate pre-flush with WFI.
3. Conduct integrity testing (bubble point or diffusion). -
Client Customizations:
1. Gamma-irradiated capsules.
2. Validation packages. -
Process Notes:
1. Required pre-use flushing.
2. Storage in cleanroom conditions. -
Features:
1. PES, PVDF, Nylon, PTFE (Cartridge, Capsule, Syringe)
2. 0.1 µm, 0.2/0.22 µm, 0.45 µm pore sizes
Description:
Sterilizing-grade membrane filters are designed for critical applications in pharmaceutical, biotech, and injectable drug manufacturing. These filters, typically with 0.22 µm or 0.1 µm pore sizes, ensure absolute retention of bacteria and mycoplasma. Materials like PES, PVDF, and PTFE offer low protein binding and high flow rates, meeting USP Class VI and FDA standards. Ideal for final filtration of APIs, vaccines, and cell culture media, they support GMP-grade sterility assurance. Available in cartridge, capsule, and disc formats, these filters are validated for sterilization processes, integrity-tested, and compatible with SIP/CIP operations.