Double Diaphragm Seals and Break Monitoring – A Safety–Net for Pharma–Production

Related Vendors

DÜPERTHAL Sicherheitstechnik GmbH & Co. KG

Donadon SDD Srl

Anton Paar GmbH

WIKA Alexander Wiegand SE & Co. KG

Seals for Sensitive Products

However, one risk remains: Unforeseen process disturbances can damage or even destroy the sensitive diaphragm, so that the fill fluid finds its way into the process. As a result, extra care must be taken when specifying the fluid for sanitary applications to ensure it is suitable for contact with the particular medium. This can be documented through conformity with the provisions of the American Food and Drug Administration (FDA).

For compliance with the GMP guidelines, further documents are required, for example a listing in the country-specific pharmacopoeia. These tolerances are, however, not unlimited: In some cases, contamination must be prevented under all circumstances and in any direction.

Thus, no fill fluid must be allowed to soil the product or escape into the environment. This is the case, for example, when producing vaccines with live viruses or of genetically modified organisms — The consequences would be dramatic in each case.

Advantages of Double Diaphragm Seals

For anyone who must exclude all eventualities, a more advanced seal is available from Wika, with a double diaphragm and diaphragm break monitoring. Using this patented system, the space between the two diaphragms is evacuated and the vacuum is monitored. The type of monitoring can be specified individually, depending on the sensitivity of the process: With regular on-site inspection, a pressure gauge with green-red display will be sufficient, in other cases a visual or audible alarm in the control room may be required.

When using media with a high risk potential, the operator can use a pressure switch which will immediately halt the process in the event of any leakage. Should the wetted diaphragm become damaged, the second forms a reliable seal to the process and maintains the pressure monitoring until the damage has been rectified. Since a break within the system is detected immediately, no microbes can get past the diaphragm without notice.

(ID:43333817)