The invoice that landed in the wrong place
In most pharmaceutical manufacturing facilities, the calibration and instrumentation team operates downstream of the process. They maintain, verify, and replace the instruments that measure and control what’s happening in the process. They respond to failures. They issue corrective actions. They keep the data trail clean.
What they don’t always get to see is where those failures actually originate.
Here’s a pattern that repeats itself more often than it should.
The sequence of events
An EPDM gasket is installed on a tri-clover connection on a lyophiliser, or a vessel, or a process line. It’s a standard gasket. It meets all the required approvals. It’s the same type that’s been used for years.
Over time, through repeated SIP cycles, through thermal cycling, through the slow degradation of its polymer matrix, the gasket begins to revert. The plasticisers migrate out. The material softens and flows into the surface texture of the ferrule faces. The cross-links that hold it in its cured, elastic state break down.
There’s no alarm for this. No leak. No visible failure. Just a gasket that, on the next scheduled changeout, doesn’t come away cleanly.
So the technician does what technicians do. They use whatever’s available to get the job done. A screwdriver between the flanges. A lever. Some force.
And the pressure transducer diaphragm, located at that connection, measuring that process, gets scored.
Where the cost goes
The instrument now reads incorrectly, or not at all. The calibration team is called. The instrument is removed, replaced, re-calibrated, and re-verified. A corrective action is raised. The documentation takes time. The downtime takes time.
Three teams are now involved in resolving a problem that originated with a component that costs less than a cup of coffee.
And unless someone in that corrective action chain asks the right question, why was the flange forced apart, the root cause never gets identified. The next gasket goes in. The cycle begins again.
The instrument didn’t fail. The connection failed. But the invoice landed with the wrong team.
Why this keeps happening
Material Selection
- EPDM is a broad category, a gasket that meets USP and FDA requirements is not necessarily a gasket that performs well under repeated SIP exposure
- Formulations containing plasticisers and low carbon black levels degrade faster, bond more aggressively to metal faces, and create exactly the removal problem described above
- The specification decision, usually made once by someone who may no longer be on site, has consequences that play out over years
No Replacement Intervals
- Most sites change gaskets reactively, when they cause a problem, when they’re visibly damaged, or when a shutdown happens to coincide
- A gasket that has been in service through 200 SIP cycles looks fine from the outside, it isn’t
- The absence of a planned replacement programme means the degradation curve always wins
The fix is not complicated
Identify every connection in a SIP-exposed application. Review the gasket material specification against the actual service conditions, not just the regulatory requirements. For high-frequency SIP applications, silicone tri-clover gaskets are a proven, direct replacement for EPDM that eliminates the bonding problem entirely.
Then define a replacement interval. Not based on visible condition. Based on service history, cycle count, and material specification. Build it into the planned maintenance programme.
The gasket costs £2. The replacement interval conversation costs an afternoon. The corrective action it prevents costs significantly more than both.
The interesting question for any engineering or quality team is this: how many of your current corrective actions would trace back upstream to a connection, a gasket, or a clamp, if someone followed the chain all the way to the beginning?
Want to talk process reliability?
Pure Transfer Ltd works with pharma and biotech facilities on high-purity process reliability, from gasket selection and clamp standards to ASME BPE-aligned installation practices and connection integrity monitoring.
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