The Challenge
The distributor’s diaphragms swelled after repeated 135°C clean-steam sterilization, losing seal force and shedding particles into hygienic lines — a critical issue for pharma customers audited under GMP. Requirements: diaphragms for DN25-DN100 sanitary valves, 200+ SIP cycles at 135°C without cracking or swelling beyond 5%, FDA 21 CFR 177.2600 and EU 1935/2004 compliance, and full traceability documentation with each batch.
Our Solution
We formulated a high-temperature platinum LSR with low extractables, validated 200+ SIP cycles at 135°C with seal-force retention and particle-shed testing, manufactured across DN25-DN100 sizes with smooth crevice-free surfaces for CIP cleanability, and issued lot-traceable FDA/EU compliance documentation with every shipment.
Results
- ✅ 200+ SIP cycles at 135°C passed with swelling below 5%
- ✅ Seal-force retention verified after full cycle program
- ✅ FDA 21 CFR 177.2600 + EU 1935/2004 documentation per lot
- ✅ Approved by pharma GMP auditors; became the distributor’s primary source
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