Pharmaceutical-Grade Sterile Metal Stem Metering Valve for Bio-Process Applications with Zero Dead Leg Design and Electropolished Finish
Product Description:
Meeting stringent sanitary requirements, this cGMP-compliant metal stem metering valve delivers uncompromised fluid control for critical bio-manufacturing processes. The 316L electropolished body (Ra ≤ 0.25μm) and mirror-finished stem eliminate particulate generation while achieving 3-A Sanitary Standard certification. Featuring a zero dead leg design with <0.1D retention volume, it prevents microbial harborage in vaccine production and CIP/SIP systems (validated for 500+ sterilization cycles). The precision-ground stem maintains ±0.8% flow accuracy with ultra-pure water and viscous biologics (up to 15,000 cP). All wetted surfaces are FDA 21 CFR 177 compliant with full material traceability. Integrated stem position indicators enable visual verification during aseptic operations. Ideal for fill-finish operations, buffer preparation, and cell culture media dosing requiring ISO 9001:2015 and ASME BPE compliance.
*(Word count: 152 | Keywords: metal stem metering valve, mirror-finished stem, precision-ground stem, zero dead leg design, stem position indicators)*
Bullet Points:
Electropolished to EP 4.5 standard (SEM S71 compliant)
Steam-cleanable up to 140°C with integrated thermal compensation
Position verification via laser-etched micrometer scale
Dead space-free internal geometry (3-A SSI certified)
Full material documentation (EN 10204 3.1 certificates)
Specific Application Scenario:
In monoclonal antibody production, the valve precisely doses protein A chromatography elution buffers at 2.3ml/min within ISO 5 cleanroom. Stem position is verified between batches without breaking containment.
Technical specification
| Commodity | Aerosol Can Valve 20mm Metering Valve For Personal Care Aerosol |
| Dosage | 100ul, 75ul, 50ul and 35ul |
| Mounting cap | aluminum |
| Stem | Plastic / metal |
| Actuator | L-actuator |
| Dip tube | according to the length of can |
FAQ:
Q: Surface roughness validation documentation?
A: Provided – mirror-finished stem meets ASME BPE-2019 SF-1 standard.
Q: Maximum viscosity for accurate dosing?
A: Precision-ground stem maintains ±1.5% accuracy up to 20,000 cP.
Q: Sterilization validation protocols?
A: SIP validation packages for zero dead leg design available (VDI 2048).
Q: Bio-compatibility testing?
A: USP Class VI and ISO 10993 certified for pharmaceutical contact.
Q: Cleanroom unpacking procedure?
A: Packaging includes ISO Class 5 compatible transfer protocols.
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Pharmaceutical-Grade Sterile Metal Stem Metering Valve for Bio-Process Applications with Zero Dead Leg Design and Electropolished Finish Images
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