1000 SIP Cycles Testing: Ease of Hygienic Union Breakdown

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 alongside products from four competitors. Each SIP cycle consisted of steam at ca. 135^oC for 60 minutes followed by cooling to less than 20^oC. This testing was carried out by an independent test house, in accordance with ASME BPE non-mandatory Appendix K.

Several comparative performance criteria were recorded with one of the most important, from a maintenance viewpoint, being how easily the hygienic union could be disassembled (i.e. how easy it is to separate the ferrules after clamp removal). This is important to ensure a quick and easy changeout of gaskets, minimising maintenance time and costs. Additionally, from a health and safety perspective, difficult to separate ferrules can pose a safety risk, particularly in maintenance scenarios at height or in areas with restricted access.

Measurement of the ease of disassembly is subjective, so the following definition was applied (Table 1).

The measurements, carried out by the independent test house, gave the following results (Table 2)

The data shows Elast-O-Pure EP75B and Competitor B gave easy ferrule separation with minimal force. Conversely, Competitors C and D could prove problematic. Competitor A lies in between these two extremes.

Analysis of Variance was then used to compare the different data sets (Figure 1).

This analysis clearly shows Elast-O-Pure EP75B and Competitor B to be easily separated allowing easy, fast and safe gasket changeout.

The excessive force needed to free gaskets from Competitors C and D, not only makes gasket changeout difficult and time consuming, but poses considerable health and safety risks, particularly in maintenance scenarios at height or in areas with restricted access. Such conditions increase the likelihood of accidents, or other injuries caused by the strenuous removal process.

This study shows that even after 1000 SIP cycles Elast-O-Pure EP75B allows easy disassembly of the hygienic union, helping to keep maintenance costs to a minimum.

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.