Documentation-rich PTFE parts for validated suites
Tubing, diaphragms, and filling change parts ship double-bagged with certificates aligned to cGMP expectations.
TOC level
<200 ppb
Response
24 hrs
Key applications
Validated PTFE components deployed across this industry.
- Single-use skid tubing and manifolds
- Stopper bowl linings and star wheels
- Isolator gloves and transfer seals
- Analytical instrument components
Suggested PTFE formats for this industry
Pair high-availability stock with custom-fabricated components to cover new programs and sustaining demand.
Regulatory & quality documentation
Every shipment lands with the compliance evidence your auditors expect.
USP Class VI & FDA 21 CFR
Biocompatibility and food contact statements issued per lot.
Gamma & EtO compatibility
Material validation for common sterilization paths.
Success story
Vaccine facility accelerated FAT approvals
Pre-flared PTFE tubing assemblies landed with IQ/OQ packets, letting the builder close qualification two weeks earlier.
FAT timeline
-14 days
Deviations
0
Assemblies/week
150
Need PTFE expertise for your industry?
Partner with JV Fluoro Industries for engineered fluoropolymer solutions backed by compliance-ready documentation and rapid response teams.