Pharmaceutical & FDA
Sanitary processing requires non-contaminating, zero-extractable sealing systems that endure aggressive Clean-In-Place (CIP) and Steam-In-Place (SIP) sterilization cycles. Gaskets and flanges must maintain structural integrity under thermal shock without leeching compounds into pure media. Compliance with FDA 21 CFR 177.1550, USP Class VI, ASME BPE, and 3-A Sanitary Standards is mandatory.
Primary Application Areas
Water for Injection (WFI) loops, API synthesis reactors, fermentation vessels, sterile fluid transfer lines, bio-reactors, and high-pressure utility steam lines.
Common Flange Types & Standards
Weld Neck Flanges (ASME B16.5 WN Class 150/300)
Deployed on high-pressure clean steam boilers, WFI thermal loops, and plant utility headers (with internally polished bores).
Slip-On Flanges (ASME B16.5 SO)
Restricted to non-critical utility lines, chilled water loops, and plant HVAC infrastructure.
Engineered Gasket & Sealing Selection
Sanitary Tri-Clamp Gaskets
Precision-molded in Virgin PTFE, USP Class VI EPDM, FKM, or Platinum-Cured Silicone for sanitary quick-disconnect unions.
Virgin & Expanded PTFE (ePTFE) Gaskets
Inert, zero-extractable sheet seals for high-purity process and chemical feed lines.
PTFE Envelope Gaskets
Elastomeric core encased in a seamless virgin PTFE shield for combined compressibility and chemical purity.
Stainless Steel RTJ Gaskets (ASME B16.20 R Octagonal)
Precision 316L SS RTJs deployed in high-pressure plant utility boilers and extreme-pressure clean-steam generation headers.
Flange Isolation Kits (FIK – TX-ISOPRO)
Full-face phenolic or G10 GRE isolation kits installed on utility boundary lines and raw water intake headers to block stray electrical currents.
