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- sales@biopharmafilters.com
Capsule Filters (Single-Use)
Capsule (Single-Use) Filters
- Description:Pre-sterilized, disposable filters for single-use setups.
- Applications: Final fill, media prep, buffer filtration.
- Formats: Gamma-irradiated capsules with sanitary connections.
- Materials:PES, Nylon, PTFE, PP.
- Pore Sizes: 0.2, 0.45, 1.0 µm.
- Compliance: USP Class VI, ISO 11137.
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SOP (Summary):
1. Gamma irradiate at 25–40 kGy.
2. Seal in sterile barrier.
3. Ensure shelf life ≤ 24 months. -
Client Customizations:
1. Custom inlet/outlet sizes. -
Process Notes:
1. No cleaning validation needed. -
Features:
1. Pre-sterilized, gamma-irradiated options
2. Membrane or depth media options
Description:
Capsule filters are self-contained, pre-sterilized filtration units optimized for single-use bioprocessing. Available in a wide range of membranes (PES, PTFE, PVDF, Nylon), they come in various lengths and fitting types to match your process scale. Capsule filters eliminate cleaning validation, reduce cross-contamination risks, and ensure process integrity in biologics and injectables. These filters are gamma-irradiated and ready-to-use under GMP manufacturing. Applications include buffer filtration, media sterilization, and final product filtration. With low extractables and integrity testing compatibility, they meet global pharmacopeia standards, making them a robust, scalable choice for modern cleanroom-based production environments.