1000 SIP Test Cycles: Gasket – Ferrule Adhesion

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 4 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, one being the adhesion of the gasket to the ferrule after steam exposure. Adhesion of the gasket is undesirable as it can make disassembly of the hygienic joint difficult and time consuming. Additionally, if any rubber is transferred to the ferrule surface this will require cleaning, further increasing maintenance costs, before replacing with a new gasket ensuring no rubber enters and contaminates the system.

The ferrules were closely examined for any particles which may have become detached from the gasket and permanently adhered to the ferrule. The adhesion of the gasket to the metal ferrule was measured using a 4-point scale (Table 1).

Competitor B performed perfectly. James Walker Elast-O-Pure EP75B, Competitors A and C performed well with some stiction, but crucially no rubber deposits on the ferrules.

Competitor D performed worst of all, leaving heavy deposits of rubber on the ferrules, therefore before reuse the ferrules will need cleaning, or replacing, increasing maintenance times and with the added risk of rubber debris from the ferrule entering the process. Failure to clean this debris from the surface could compromise future sealability of the hygienic joint. Figure 2 below shows examples of the ferrules after removal of Competitor D seals.

After 1000 SIP cycles, Elast-O-Pure EP75B showed no signs of adhesion to the ferrules and left no deposit on the ferrule faces when the seal was removed.

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.