Clamp SS316L Hygienic Diaphragm Valve — High Purity

Cematic's clamp hygienic diaphragm valve is the standard solution for high-purity processes where cross-contamination is unacceptable. It is manufactured from 316L stainless steel with an interior mirror-polished finish of Ra ≤ 0.2 µm.

This ensures zero external leaks and maximum cleanliness in each cycle. Therefore, it is the preferred choice in the pharmaceutical, food, and biotechnology industries.

Unlike conventional valves, the diaphragm acts as a hermetic seal between the fluid and the mechanism. This eliminates dynamic packing and, likewise, reduces the risk of product contamination.

The 3A clamp connection also allows for quick disassembly for maintenance or inspection without special tools.

Why choose Cematic's hygienic diaphragm valve

Firstly, its mirror-polished finish of Ra ≤ 0.2 µm prevents residue accumulation. Consequently, CIP and SIP processes are more efficient than with valves with an Ra ≤ 0.8 µm finish.

On the other hand, 316L stainless steel offers greater resistance to chlorides and corrosive agents than SS304. It is also the preferred material in demanding CIP protocols. Therefore, it is the preferred material in environments with demanding cleaning protocols.

Its manual operation also offers direct, precise, and reliable flow control. However, it is also available with a pneumatic actuator for integration into automated systems. In any case, the assembly is delivered tested and ready for installation.

Operating principle — Hygienic Diaphragm Valve

The diaphragm is a flexible EPDM + PTFE membrane that separates the fluid zone from the sealing mechanism zone. When opened, the diaphragm lifts, allowing bidirectional fluid flow.

When closed, on the other hand, the diaphragm compresses against the body seat and blocks the flow. In this way, the fluid never comes into contact with dynamic packing, lubricants, or moving metal parts.

This total separation also eliminates dead zones where product could accumulate between cycles. Therefore, the hygienic diaphragm valve is the correct component when aseptic fluid integrity is a non-negotiable process requirement.

Construction materials

The body is made of 316L stainless steel, which is the standard material in high-purity applications. Its molybdenum content also offers greater resistance to chlorides and CIP agents than SS304. The diaphragm is made of EPDM + PTFE, which is the correct combination for aseptic processes.

EPDM provides the necessary elasticity for hermetic sealing. PTFE also coats the face in contact with the fluid, ensuring total chemical inertness. Finally, the interior finish of Ra ≤ 0.2 µm is the most demanding in the family, which eliminates any roughness where microorganisms or residues could accumulate.

Technical specifications

Fluid compatibility

This hygienic diaphragm valve with an EPDM + PTFE diaphragm is compatible with the most demanding fluids in the sanitary industry. The main groups are described below:

• Purified water and water for injection (WFI) — SS316L does not contribute metal ions; therefore, it is the standard material in high-purity pharmaceutical water distribution systems.
• Culture media, vaccines, and biological products — total fluid-mechanism separation is the fundamental requirement in biotechnology; likewise, PTFE on the diaphragm's face does not cause chemical contamination of the product.
• Viscous food fluids — yogurt, creams, syrups, purees — the diaphragm handles viscous fluids without retention in cavities; additionally, the smooth and bidirectional opening prevents phase separation in emulsified products.
• CIP agents — caustic soda, nitric acid, peracetic acid up to 110 °C — PTFE is inert to most common CIP agents; however, verify concentration and temperature with the Cematic technical team for extreme conditions.
• High-purity and corrosive chemical fluids — PTFE resists a wide range of acids, bases, and solvents; for extremely aggressive fluids or above 110 °C, consult with the Cematic technical team.

Applications of the hygienic diaphragm valve

Pharmaceutical and Biotechnology Industry

The hygienic diaphragm valve is the standard component in production lines for vaccines, serums, and culture media. The total separation between the fluid and the mechanism also ensures process sterility in each cycle.

Therefore, it is the required valve in aseptic piping systems where the product must remain sterile from production to packaging.

Food and Beverage Industry

In the processing of dairy products, beer, juices, and carbonated beverages, this valve ensures that the fluid does not touch lubricants. Likewise, it also does not come into contact with moving parts.

It is also the correct option for dosing additives and viscous syrups, as the diaphragm prevents product retention in internal cavities. Consequently, batch changes are cleaner and faster.

CIP/SIP Cleaning and Sterilization Systems

In cleaning and sterilization circuits, this valve also acts as a critical flow control component. Its Ra ≤ 0.2 µm finish also ensures that cleaning agents reach all surfaces without shadow zones.

Therefore, CIP cycles are more efficient. SIP cycles also completely sterilize the fluid zone up to 110 °C without disassembling the valve.

Cosmetics and Personal Care Industry

In production lines for creams, lotions, and shampoos, the total separation between fluid and mechanism also prevents contamination with lubricants.

Therefore, it is the correct component in lines where viscous fluids or sensitive active ingredients are handled. Likewise, the 3A clamp disassembly facilitates quick diaphragm changes between formulations without special tools.

Fine Chemical Industries

In the handling of corrosive chemicals, this valve prevents cross-contamination. The diaphragm's hermetic seal also prevents leaks at all times. Additionally, PTFE on the fluid contact face resists most corrosive agents within the working temperature range.

Consequently, it is the correct option in fine chemical plants where fluid purity is as important as installation safety.

For the complete range of hygienic valves, see hygienic valves collection →

Technical Data Sheet