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Testing to improve biopharmaceutical manufacturing efficiency

Comparative performance testing of top five hygienic clamp gaskets over 1000 SIP cycles

The most common question our customers ask is how long do your seals last? Our answer is not given in weeks, months or years, but in Steam-in-Place (SIP) cleaning cycles.

Previous testing to 500 SIP cycles has shown James Walker’s Elast-O-Pure EP75B to easily meet these requirements. In an effort to better define the true performance capability of Elast-O-Pure EP75B, it was decided to significantly increase the number of cycles and carry out comparative testing against four top competitors in the market.

Download the full 1000 SIP cycle technical paper now

Since the Covid pandemic, the Biopharmaceutical Industry has a renewed focus to manufacture high quality, effective and safe drugs more efficiently in order to meet global patient demand. Industry 4.0, AI, Single Use Technology are all helping meet this goal.

Within the world of the high purity elastomer, the role these parts play in manufacturing efficiency is linked to high levels of performance over extended periods of time. 

James Walker commissioned independent testing of Elast-O-Pure EP75B hygienic seals (Triclamp® type) to 1000 steam-in-place (SIP) cycles against four other market-leading material options. Each SIP cycle consisted of steam at ca. 135oC for 60 minutes followed by cooling to less than 20oC. This testing was carried out by an independent test house, in accordance with ASME BPE non-mandatory Appendix K.

The ASME BPE standard only defines intrusion as a measured performance characteristic. However, in this study other performance characteristics, important in maintenance schedules, were also measured including adhesion of the seal to the ferrule, ease of hygienic union breakdown and required retorque to return it to the original value. 

Details of the processes carried out, the observations taken plus results and conclusions are all laid out in the full technical paper, available to download on this page.

1000 SIP cycle test
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