What certifications does the Saunders HC4 diaphragm valve hold for pharmaceutical applications?

The Saunders HC4 is fully compliant with FDA CFR 177.1550 (PTFE) and 177.2600 (Elastomer), USP Class VI, 3A certification, and ASME BPE standards. Material traceability is provided to EN 10204 3.1.

What surface finish options are available, and which is recommended for WFI systems?

Surface finishes range from Ra 30 µin (0.8 µm) to Ra 10 µin (0.25 µm), in mechanical polish or mechanical plus electropolish. For WFI and high-purity water systems, electropolished finishes (SF4 or SF5 per ASME BPE) are recommended for optimal corrosion resistance and cleanability.

What is the maximum size available in forged body construction?

Forged bodies are available from DN15 to DN80 (1/2" to 3"). For larger sizes (DN100 to DN150 / 4" to 6"), machined-from-block construction is used, providing equivalent surface integrity and metallurgical quality.

Are the diaphragms Animal Derived Component Free (ADCF)?

Yes, Saunders offers ADCF diaphragm options suitable for biotech and pharmaceutical processes where animal-derived component-free materials are mandatory.

Can the valve be installed in both horizontal and vertical orientations?

Yes, the Saunders HC4 is designed for self-draining in both vertical and horizontal orientations. Drainability depends on valve size, surface finish, pipe angle (2–3 degrees recommended), and media viscosity. Over 100 P&ID orientations are supported.

CRANE CHEMPHARMA & ENERGY · DIAPHRAGM VALVES

Saunders HC4 Aseptic Diaphragm Valves – Crane ChemPharma – Hygienic Process Valves

Name: Saunders HC4 Aseptic Diaphragm Valves – Crane ChemPharma – Hygienic Process Valves
Brand: Crane ChemPharma & Energy

Saunders HC4 aseptic diaphragm valves by Crane for biotech, pharma & food processing. FDA, ASME BPE compliant. Available at PC Engineering India.

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Overview

The Saunders HC4 Aseptic Diaphragm Valve from Crane ChemPharma is engineered for critical hygienic and sterile process applications in pharmaceutical, biotech, and food & beverage industries. The weir-type diaphragm design provides cavity-free, self-draining flow paths essential for maintaining sterility and facilitating CIP/SIP processes.

Saunders invented the diaphragm valve concept and continues to lead innovation in aseptic valve technology. The HC4 series features forged 316L stainless steel bodies with controlled sulfur content per ASME BPE standards, ensuring optimal surface integrity for high-purity applications. These valves are designed for full compliance with global regulatory standards including FDA, USP Class VI, 3A, and ASME BPE.

The modular actuator system and compact pneumatic design allow for flexible installation configurations, making the Saunders HC4 suitable for standard 2-way, tandem, and custom block valve assemblies across various process orientations.

Key Features

Forged 316L/1.4435 stainless steel bodies with controlled sulfur (0.005–0.017%) per ASME BPE
Cavity-free, self-draining weir-type design for aseptic applications
Low ferrite content (<0.5% max) to reduce oxide migration in high-purity water systems
Full traceability to EN 10204 3.1 with serialized body marking per ASME BPE DT 11-1
Available with weld ends and hygienic tri-clamp connections
PTFE and elastomer diaphragms compliant with FDA CFR 177.1550 and 177.2600
Compact modular pneumatic actuators (S360 series)
Multiple surface finish options including electropolished ASME BPE compliant finishes

Specifications

Parameter	Value
Body Material	316L Stainless Steel (ASTM A-182 / DIN 1.4435)
Size Range (Forged)	DN8 – DN80 (1/4" – 3")
Size Range (Machined)	DN100 – DN150 (4" – 6")
Size Range (Cast)	DN8 – DN100 (1/4" – 4")
End Connections	Butt Weld, Tri-Clamp, OD Tube, DIN, ISO, SMS, Schedule Pipe
Surface Finish (Ra)	10–30 µin (0.25–0.8 µm), Mechanical or Electropolished
ASME BPE Surface Codes	SF1 to SF6
Compliance	FDA, USP Class VI, 3A, ASME BPE, ISO 9001, CE/PED 97/23/EC
Diaphragm Materials	PTFE, Modified PTFE, Elastomers (ADCF available)
Ferrite Content	<0.5% max

Applications

Saunders HC4 aseptic diaphragm valves are specified for critical process applications requiring sterility, cleanability, and regulatory compliance:

- Pharmaceutical & Biotech: API manufacturing, sterile filling lines, buffer preparation, WFI systems - Food & Beverage: Dairy processing, brewing, beverage production, fermentation - Personal Care & Cosmetics: Cream and lotion manufacturing, emulsion processes - Specialty Chemicals: High-purity chemical processing, biofuels, silicon manufacturing

These valves are ideal for CIP/SIP systems, sampling ports, drain valves, and any application where zero dead-leg and complete drainability are required.

Product Images

Forged Stainless Steel Valve Body with Tri-Clamp and Weld Ends

Frequently Asked Questions

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