1000 SIP cycle test: Summary of results

Since 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 against four other market-leading material options. Each SIP cycle consisted of steam at ca. 135^oC for 60 minutes followed by cooling to less than 20^°C. 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. Individually, each of these characteristics have been the basis of previous posts, but are summarised here for clarity, see the table below.

Adhesion: Elast-O-Pure EP75B and Competitors A, B and C all gave good adhesion results, being easily removed and leaving no rubber deposit on the ferrule. Competitor D on the other hand was firmly adhered to the ferrule and left heavy rubber deposits on the ferrule. This will require careful cleaning, or even replacement of the ferrule, resulting in longer, more costly maintenance schedules.

Ease of breakdown: This was a measure of how much force was required to separate the ferrules after the clamp had been removed. Elast-O-Pure EP75B and Competitor B gave easy breakdown requiring minimal force to separate the union. Competitors A, C and D required some force to separate the ferrules; Competitors C and D were particularly bad, requiring great force to separate the ferrules. This leads to longer maintenance times and could present a health and safety hazard in difficult to reach unions or at height.

Retorque: This is essentially a measure of the retained sealing force after exposure to 1000 SIP cycles, with lower values indicating higher retained sealing force. Elast-O-Pure EP75B gave the lowest values and highest retained sealing force. Competitor D gave good results. However, Competitors A, B and C required extensive retorquing suggesting these products will require retorquing on a regular basis during operation, which is costly.

Intrusion: Only Elast-O-Pure EP75B met the ASME BPE intrusion requirements after SIP exposure. All other products showed very high intrusion which can lead to difficulties in cleaning in place and the potential for contamination.

In conclusion, only Elast-O-Pure EP75B performed well in all four tests with no adhesion, easy disassembly, retained most sealing force and met the intrusion requirements of the ASME BPE standard.

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.