GMP News No. 187
08 April 2002
FDA-compliant Seal Materials in the Endurance Test
Production and bottling machines in the pharmaceutical industry, but also plants for producing different kinds of food are more and more frequently flushed through with aggressive cleaning agents. These cleaning and sterilisation procedures, which can be carried out without the work-intensive dismantling of the machines, are called cleaning in place (CIP) and sterilisation in place (SIP).
Unfortunately, by far not all of the elastomer seal materials withstand the CIP and SIP media, which can sometimes have a destructive effect. When in contact with these cleaning agents, some seal materials swell up and then extrude into the gap; others are in fact destroyed.
In search of a universal material that remains uninfluenced by most of the very aggressive CIP and SIP media, large series of tests have been carried out, the results of which may even surprise experts. Especially as certain seal materials are expressly recommended for the use in CIP processes by relevant guidelines, e.g. DIN standards, however in the test they proved to be unsuitable.
Another group of materials withstand excellently a specific class of CIP media, but when exposed to other cleaning agents their robustness turns out to be very poor. There was a single material from the group of perfluor elastomers that showed itself to be outstandingly resistant to all current CIP media.
A second material, EPDM 2, also got very good marks and showed only deficiencies in the presence of an injection medium on the basis of hydrogen peroxid/tensids of 0.5% to 1%. You can see in the following table which seal materials were tested and what the results were.
"FDA-compliant seal materials" is one of the topics with which we will deal at our 4-day GMP Education Course "Pharmaceutical Engineering" in Copenhagen, Denmark, from 9-12 December 2002.
Source: Dr Burkhard Ledig, Busak+Shamban