CRANE CHEMPHARMA & ENERGY · DIAPHRAGM VALVES
Saunders Aseptic Diaphragm Valves – FDA Conforming Biopharmaceutical Valves
Saunders aseptic diaphragm valves by Crane for biopharm applications. FDA conforming, 316L SS, cavity-free design. DN8-DN150 sizes available.

Overview
Saunders aseptic diaphragm valves are precision-engineered flow control components designed specifically for biopharmaceutical, pharmaceutical, and high-purity process applications. As the original inventor of the diaphragm valve, Saunders (a Crane brand) has pioneered aseptic valve technology with cavity-free, self-draining body designs that eliminate entrapment areas and maintain sterility throughout the process cycle.
These valves feature a top-entry design that permits in-line maintenance without removing the valve from welded systems—a critical advantage for validated pharmaceutical installations. The isolating diaphragm provides bubble-tight closure against both pressure and vacuum conditions while offering bi-directional flow capability. All wetted surfaces are manufactured from 316L/1.4435 stainless steel with maximum ferrite content of 0.5%, reducing oxide migration potential in high-purity water systems.
Saunders diaphragm valves are fully FDA conforming and meet ASME BPE (Bioprocessing Equipment) standards as well as cGMP (current Good Manufacturing Practice) principles. The diaphragms are USP Class VI tested and manufactured in-house from raw polymer with complete traceability back to the rubber blend characteristics.
Key Features
- Cavity-free body design – Eliminates entrapment areas, enhances cleanability and diaphragm life
- Top-entry maintenance – Service valve without removal from welded piping systems
- 316L/1.4435 stainless steel construction – Maximum 0.5% ferrite content for high-purity applications
- FDA conforming components – Bonnet shell and internal parts fully FDA compliant
- USP Class VI tested diaphragms – Full material traceability from raw polymer to finished component
- Self-draining profile – Optimised for CIP/SIP processes and aseptic system requirements
- Bubble-tight bi-directional closure – Seals against both pressure and vacuum
- PES bonnet assembly – Polyethersulphone construction suitable for autoclaving up to 160°C
Specifications
| Parameter | Value |
|---|---|
| Body Material | 316L/1.4435 Stainless Steel |
| Maximum Ferrite Content | 0.5% |
| Size Range (Forged) | DN8 – DN80 |
| Size Range (Solid Block) | DN100 – DN150 |
| Size Range (Cast) | DN8 – DN100 |
| Bonnet Material | Polyethersulphone (PES) |
| Maximum Autoclave Temperature | 160°C |
| Diaphragm Certification | USP Class VI |
| End Connections | Butt Weld, Tri-Clamp, DIN/ISO, O.D. Tubing |
| Standards Compliance | ASME BPE, FDA, cGMP |
| Flow Direction | Bi-directional |
Applications
Saunders aseptic diaphragm valves are standard components in industries requiring stringent sterility and cleanability:
- Biopharmaceutical manufacturing – Fermentation, purification, chromatography systems - Pharmaceutical production – API processing, WFI distribution, clean utilities - Biotechnology – Cell culture, vaccine production, blood plasma processing - Food and beverage – Dairy processing, brewing, aseptic filling lines - High-purity water systems – PW, WFI, and clean steam distribution
Available configurations include standard 2-way valves, zero dead-leg (ZDT) designs, close-coupled branch valves (CCB), tank bottom valves, tandem valves, and custom Bio-Block machined manifolds for complex process requirements.
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