FDA-compliant Seal Materials in the Endurance Test

GMP News No. 187

GMP News
08 April 2002

FDA-compliantSeal Materials in the Endurance Test

Production and bottling machines in the pharmaceutical industry, but alsoplants for producing different kinds of food are more and more frequentlyflushed through with aggressive cleaning agents. These cleaning andsterilisation procedures, which can be carried out without thework-intensive dismantling of the machines, are called cleaning in place(CIP) and sterilisation in place (SIP). 

Unfortunately, by far not all of theelastomer seal materials withstand the CIP and SIP media, which can sometimes have adestructive effect. When in contact with these cleaning agents, some seal materials swell up and then extrude into the gap; others are infact destroyed.

In search of a universal material that remains uninfluenced by most ofthe very aggressive CIP and SIP media, large series of tests have been carriedout, the results of which may even surprise experts. Especially as certainseal materials are expressly recommended for the use in CIP processesby relevant guidelines, e.g. DIN standards, however in the test theyproved to be unsuitable.

Another group of materials withstand excellently a specific class ofCIP media, but when exposed to other cleaning agents their robustnessturns out to be very poor. There was a single material from the group ofperfluor elastomers that showed itself to be outstandingly resistant toall current CIP media.

A second material, EPDM 2, also got very good marks and showed onlydeficiencies in the presence of an injection medium on the basis ofhydrogen peroxid/tensids of 0.5% to 1%. You can see in the following tablewhich seal materials were tested and what the results were.

Source: Dr Burkhard Ledig, Busak+Shamban

Harald Martin



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