Eliminate Risk

Eliminate Risk

2017-09-01

Reliability of weir style valve diaphragms has been a hot topic for well over a decade.  In response, our industry has attempted to quantify expected lifespan of valve diaphragms based on the number of cycles (actuations, exposure to steam and CIP chemicals) in a standard biopharma process.

The reasons for this increased focus is that according to leading industry user groups soft part change-out programs accounts for over 50% of all planned maintenance activity.  Additionally, soft-part issues account for 20% of all equipment deviations and 10% or all corrective maintenance.  Most important, soft part issues represent the number on contamination risk in our industry.

From the user side, the industry describes excessive diaphragm replacement and the unpredictable nature of diaphragm life as major obstacles to production goals.  This is critically important because even a single failure during production can result in millions of dollars in lost production.

Although not part of the discussion of poor diaphragm performance, there is also the process design issue associated with weir style valves and the inability to eliminate dead-legs as well as reduce unnecessary piping.

A key to the well documented performance and reliability issues associated with weir style valves is compression set of the EPDM formulation for the main product facing diaphragms as well as the backing diaphragm for PTFE faced diaphragms. The reliability and type testing is focused on the performance of these EPDM elastomers with hot WFI viewed as the worst case scenario.

The Rattiinox CAD aseptic valve addresses these issues with a best in class precision machined PTFE diaphragm (PTFE USP Class VI-121°) with integral stainless steel pressure contrast armature.  The CAD valve diaphragm mounts to the manual or pneumatic actuator with a unique ball and cup system that allows the diaphragm to adjust to the valve body sealing point. Depending on the application CAD valves can be equipped with short or extended length diaphragms. The solid PTFE diaphragm allows the CAD valves to be used in a much higher temperature range than traditional weir diaphragm valves. The operating design temperature of the CAD valves is -80 to 200 °C (-112 to 392 °F).

  

The CAD valve sealing rings, made on stainless steel as well as all parts of manual and pneumatic actuators, is designed to provide the optimum compression on the diaphragm sealing point.  The valve body seal is not affected by routine valve temperature cycling.

 

CAD valves benefits:

- Optimized CIP-SIP cycles

- No unused portions

- Flush flow design

- Easy process validation

- Wide range of design possibilities to meet unique applications

- Extensive technical documentation for validation

- Design free from asymptotic seals

 

The CAD family valve range is extensive. Our specialists in process design will support you in selecting the appropriate type. We can also help you optimize your solution preparation system in order to achieve a design free of unused portion piping and zero dead legs, with minimal product hold up in a compact design with fast and effective CIP and SIP cycles.

 

Standard preassembled valves: a variety of valve assemblies are available to speed up process construction. Point of use, bottom drain point, and others are available as standard products.

Tailored valves and valves assembly: if required, our specialists are able to quickly design, build and delivery special valves or assemblies.

Support: this guideline will help you with the correct valve selection and suggest alternative solutions according to your needs.

Our goal is to improve general performance in terms of effective cleaning (CIP), sterilizations (SIP) and complete drainability.  For additional information or support feel free to contact us at info@rattiinox.com or call the nearest Official CAD Distributor by looking at our website: http://www.rattiinox.com/en/contact-us

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