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Intrusion can result in reduced flow and difficulty in cleaning in place, leading to potential cross‑contamination.
August 14, 2025Since the Covid pandemic, the Biopharmaceutical Industry has a renewed focus to manufacture high quality, effective and safe drugs more efficiently 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 are linked to high levels of performance, over extended periods of time. 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 SIP cycles.
James Walker commissioned independent testing of Elast-O-Pure EP75B hygienic seals (Triclamp® type) to 1000 steam-in-place (SIP) cycles alongside products from four competitors. 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.
Several performance parameters were assessed, a key one being intrusion: how much the seal has protruded into the process flow. Intrusion, though not visible during processing, can be a ‘silent killer’ as excess intrusion results in reduced flow and difficulty in cleaning in place, leading to potential cross-contamination, Additionally, there is always the possibility of the intruding portion of the seal breaking off and entering the process stream.
ASME BPE defines seal intrusion as: “Hygienic seals shall meet and be designated within one of the following intrusion categories when tested:
(a) Intrusion Category I. Seals having a maximum intrusion/recess of 0.025 in. (0.6 mm).
(b) Intrusion Category II. Seals having a maximum intrusion/recess of 0.008 in. (0.2 mm).”
Comparison of intrusion data from the 1000 SIP cycle testing, using analysis of variance (ANOVA) techniques, demonstrated the following;
The chart clearly shows that Elast-O-Pure EP75B gaskets demonstrated the best performance with 90% of the gaskets sampled still meeting ASME BPE 2024 Category 1 requirements even after 1000 cycles.
In contrast, all of the other tested gaskets (100%) failed to meet the ASME BPE 2024 standard.
Excessive intrusion poses significant risks, including reduced cleanability and an increased likelihood of bioburden retention, which may lead to contamination issues. As a result, these gaskets are ultimately not GMP compliant according to the ASME BPE 2024 standards. An example of the intrusion encountered is shown below.
To determine the potential effect on process flow, the reduction in cross sectional area due to intrusion was determined for 3 gasket sizes, 1”, 1 ½” and 2”. The results are shown in the table below.
The results are surprising with, in some cases, up to 36% reduction in cross sectional area, and hence, potentially flow.
In summary, Elast-O-Pure EP75B has minimal intrusion, even after 1000 SIP cycles, still conforms to ASME BPE requirements and consequently has a minor effect on flow compared with the four competitor products.
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 by following this link.
