PHARMACEUTICAL APPLICATION
Configure a single-use fluid path for wetting, testing, rinsing, venting, primary filtration, and redundant filtration to test filter integrity after sterilization and before use.
PROCESS CHALLENGES
SELECTION WORKFLOW
Confirm the operating envelope and compatibility of the complete fluid path.
Confirm single, primary-and-redundant, or redundant filtration, along with each filter membrane, area, and connection.
Define the bubble-point, diffusion-flow, or other integrity test method and the wetting, venting, and rinsing steps.
Configure pressure-rated tubing, pinch clamps, vent filters, connectors, bags, and the pre-sterilized delivery format.
MATCHED PRODUCTS
A starting point for selection. Confirm each specification against the actual process and validation requirements.
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Single-use systemsA customized single-use assembly for post-sterilization, pre-use integrity testing of sterilizing filters, with a complete aseptic flow path for wetting, gas testing, flushing, and primary/redundant filtration workflows.
FiltrationA high-flow capsule filter with a hydrophilic asymmetric PES membrane for filtering buffers, culture media, serum, reagents, and final drug product.
FiltrationA single-use vent filter with a hydrophobic polyethylene membrane for compressed gas, reactor exhaust, and sterile venting of bottles and liquid-storage containers.
FiltrationA 0.2 μm hydrophobic PTFE membrane that combines chemical resistance, thermal stability, and gas flow for critical-process sterile venting.
Single-layer tubingUses 83 Shore A high-hardness platinum-cured silicone for high burst pressure, full vacuum, and low-pulsation transfer in fill-finish, PUPSIT, and high-viscosity fluid applications.
Single-use systemsUses SIB® smooth-bore overmolding technology to form customizable branched manifolds from biopharmaceutical-grade silicone tubing, reducing hold-up zones, leak points, and on-site assembly steps associated with conventional connectors for complete sterile fluid-transfer systems.
Single-layer tubingThermoplastic elastomer tubing for pharmaceutical and biopharmaceutical fluid handling, suitable for peristaltic pumping, aseptic welding, heat sealing, and single-use assemblies.
Single-layer tubingPlasticizer-free, clear, flexible high-purity tubing for sensitive-fluid transfer, aseptic filling, and media transfer under vacuum conditions.
Single-layer tubingUltra-high-purity platinum-cured silicone tubing that withstands repeated steam sterilization for biopharmaceutical fluid transfer and single-use assemblies.
FAQ
No. The configuration changes with filter count, wetting method, integrity test equipment, primary-and-redundant arrangement, and production process, so it should be designed from the process flow diagram.
Integrity testing can introduce gas pressure. Tubing hardness, dimensional stability, connection method, and pinch-clamp locations affect test reliability and safety.
