Pharmaceutical Processing
When your process is validated, your seal materials need to be too.
Pharmaceutical and biotech manufacturing demands more from seals than any other industry. Every elastomeric component in direct or indirect product contact must be validated for extractables and leachables, tested to USP Class VI, and documented for regulatory audit. The wrong material — even a technically functional one — can invalidate a batch or trigger an FDA warning letter. PTFE, FFKM, ultra-pure silicone, and ePTFE are the workhorses here; the choice between them comes down to chemistry, cleaning cycle, and what your validation package requires.
Our Products
ELASFOR Product Line — Pharmaceutical Applications
| ELASFOR Product | Pharmaceutical Application |
|---|---|
70×70
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Spring-loaded PTFE U-cups and lip seals for reactor agitator shafts, transfer pumps, and valve stems — inert, non-extractable, CIP/SIP compatible to 260°C |
70×70
O-rings — FFKM, Silicone, FKM, PTFE-encapsulated
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Reactor vessel ports, valve bodies, instrument connections — FFKM for aggressive solvents and wide-range CIP/SIP; platinum-cure silicone for ultra-pure aseptic lines; encapsulated for steam sterilization cycles |
| ePTFE gaskets and joint sealant for reactor flanges, lyophilizer doors, and autoclave connections — near-zero extractables, bi-directional sealing, compatible with all CIP chemistries | |
70×70
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Tri-clamp sanitary gaskets (EPDM, silicone, PTFE, FKM) cut to any size; manhole and inspection port gaskets; sterile filter housing gaskets — 3-A / EHEDG compliant profiles available |
70×70
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Reactor agitator and mixer shaft seals — double mechanical seals with sterile water or nitrogen barrier for aseptic vessels; SiC/SiC face pairs for SIP steam service |
70×70
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Autoclave door seals, lyophilizer chamber door seals, isolator glove box port seals — silicone or EPDM profiles; USP Class VI compliant grades available |
70×70
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Diaphragm seals for sterile sampling valves, actuator membranes for aseptic filling machines, custom-profiled seals for proprietary bioreactor designs |
70×70
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PTFE braided packing for utility pump glands and non-aseptic process valve stems — FDA 21 CFR 177.1550 compliant PTFE grades |
Regulatory documentation is a procurement gate in pharmaceutical — every product-contact seal requires a USP Class VI certification, extractables/leachables data, and a statement of compliance with FDA 21 CFR 177.2600 or 177.1550. We provide full compliance documentation with all pharma-grade seal orders.
Applications
Common Sealing Applications
Reactor & Vessel Agitator Shaft Seals
Stainless steel pharmaceutical reactors, bioreactors, and mixing vessels operating under CIP (NaOH 1–2%, HNO₃ 0.5–1%) and SIP (steam 121–134°C). Agitator shafts require seals that are simultaneously inert to product, compliant with regulatory requirements, and capable of surviving hundreds of thermal CIP/SIP cycles without dimensional change or extractable release.
Spring-loaded PTFE lip seals maintain consistent contact force as the PTFE lip wears — critical on long-interval pharma maintenance schedules. Double mechanical seals with sterile water or nitrogen barrier for aseptic bioreactor vessels. Encapsulated O-rings (PTFE jacket over FKM or silicone core) for static connections on vessel ports where full PTFE stiffness would prevent groove seating.
USP Class VI · FDA 21 CFR 177.1550 · ASME BPE · 3-A Sanitary Standards · EU GMP Annex 1
Tri-Clamp Sanitary Connections
The standard connection throughout pharmaceutical and biotech piping — reactors, heat exchangers, pumps, valves, filter housings, sampling ports. Gasket material selection drives compliance: EPDM for aqueous and alkaline CIP; silicone for steam and aroma-sensitive products; PTFE for solvent lines and maximum chemical inertness; FKM where cleaning agents include oxidizers or aromatic solvents.
Platinum-cure silicone is mandatory over peroxide-cure where extractables matter — peroxide-cure silicone releases volatile by-products detectable in headspace analysis. PTFE gaskets for solvent lines but require higher clamp torque and are prone to cold-flow relaxation — check bolt load after first thermal cycle. All tri-clamp gaskets must be crevice-free per 3-A and EHEDG — inner diameter must be flush with pipe bore.
USP Class VI · FDA 21 CFR 177.2600 · 3-A Sanitary Standards · EHEDG · ASME BPE SF1
Aseptic Filling Lines & Sterile Transfer
Vial filling, syringe filling, lyophilized product lines, and sterile liquid transfer in ISO Class 5 environments. Seals must pass particulate testing (USP <788>), generate zero extractables above validated thresholds, and survive repeated H₂O₂ VHP sterilisation cycles used in isolators and RABS systems. FFKM and ultra-pure platinum-cure silicone are the only elastomers that reliably satisfy all three requirements simultaneously.
FFKM (perfluoroelastomer) provides the broadest chemical resistance of any elastomer — compatible with H₂O₂ VHP, IPA, acetone, MEK, concentrated NaOH, and steam SIP simultaneously. Platinum-cure silicone for ultra-pure applications where FFKM cost is not justified — confirm extractables profile against your specific cleaning agents. Encapsulated O-rings (PTFE jacket over FKM or silicone core) where groove geometry is fixed and full solid PTFE hardness would prevent seating.
USP Class VI · USP <87> · USP <88> · ISO 10993 · EU GMP Annex 1 · FDA 21 CFR Part 211
Solvent & Aggressive Chemical Processing
API synthesis reactors, solvent recovery systems, chromatography skids, and extraction columns handling concentrated organic solvents, strong acids (HCl, H₂SO₄), strong bases (NaOH 30–50%), and oxidising agents (H₂O₂, peracetic acid). At this chemical intensity, only FFKM and ePTFE provide the combination of chemical inertness, temperature resistance, and compliance documentation that a validated pharma process requires.
FFKM (Kalrez Grade 4079, Chemraz 505/510) for broad solvent and chemical resistance — compatible with virtually all pharmaceutical solvents and cleaning agents; temperature range −15°C to +275°C. ePTFE gaskets for flange connections — near-zero extractables, bi-directional sealing, and no cold-flow relaxation compared to solid PTFE sheet. Spring-energized PTFE lip seals on pump and agitator shafts where dynamic sealing is required and no elastomeric compound is acceptable.
USP Class VI · FDA 21 CFR 177.1550 · ISO 10993-1 · ASME BPE
Lyophilizers, Autoclaves & Isolators
Freeze dryers (lyophilizers), steam autoclaves, hydrogen peroxide VHP isolators, and RABS (Restricted Access Barrier Systems). These are the most demanding static sealing applications in pharmaceutical manufacturing — extreme temperature range, vacuum-to-pressure cycling, and frequent chemical sterilisation with H₂O₂ concentrations up to 1,000 ppm. ePTFE and FFKM are the only materials that reliably cover the full operating envelope.
ePTFE gaskets for lyophilizer and autoclave door flanges — flexible at −50°C, inert to H₂O₂ VHP, minimal compression load, and no cold-flow relaxation under years of cyclic loading. Platinum-cure silicone extruded profiles for autoclave door perimeter seals — remains flexible from −60°C to +230°C. FFKM O-rings for vacuum system connections where outgassing and extractables must be minimised for chamber contamination control. Do not substitute standard FKM in lyophilizer door applications — brittleness at −40°C causes seal cracking and vacuum integrity failure.
USP Class VI · EU GMP Annex 1 (2022) · ISO 14644 · FDA 21 CFR Part 211.65
Compliance
Governing Standards
| Standard | Scope | What It Covers for Seals |
|---|---|---|
| USP Class VI | Plastic materials — biological reactivity | Systemic toxicity, intracutaneous reactivity, and implantation testing; required for all seals in direct or indirect product contact in pharmaceutical manufacturing |
| USP <87> / <88> | Biological reactivity tests — in vitro / in vivo | Cell-based cytotoxicity (<87>) and in-vivo animal testing (<88>) for elastomeric and polymeric materials; <88> Class VI is the highest passing standard for pharmaceutical use |
| FDA 21 CFR 177.1550 | Perfluorocarbon resins (PTFE, FFKM) — food/drug contact | Approved PTFE and FFKM compound formulations; permitted additives and filler limits; extractable thresholds under pharmaceutical processing conditions |
| FDA 21 CFR 177.2600 | Elastomeric articles for repeated food/drug contact | Approved base elastomers (FKM, silicone, EPDM); vulcanization additive restrictions; extractable limits in aqueous, fatty, and alcohol media |
| FDA 21 CFR Part 211 | cGMP for finished pharmaceuticals | Equipment must be cleanable, non-reactive, non-additive, non-absorptive; requires documented material qualification for all product-contact seals |
| ASME BPE | Bioprocessing Equipment standard | Surface finish (SF1–SF6), tri-clamp gasket dimensions, crevice-free design criteria, and material requirements for pharmaceutical and biotech process equipment |
| 3-A Sanitary Standards | Dairy/food/pharma equipment design | Crevice-free geometry, self-draining surfaces, and cleanability requirements; tri-clamp gasket geometry and material compliance |
| EU GMP Annex 1 (2022) | Manufacture of sterile medicinal products | Contamination control strategy (CCS) requirements; seal materials in aseptic areas must be qualified for extractables/leachables; VHP and SIP compatibility mandatory |
| ISO 10993 | Biological evaluation of medical devices | Cytotoxicity, sensitisation, and systemic toxicity testing; referenced when pharmaceutical seals are used in drug delivery device components |
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