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Gaskets for pharmaceutical plants
Pharmaceutical plants run reactors, solvent recovery, purified water and clean steam systems where contamination and leaks are not acceptable. Buyers need consistent materials and paperwork for every batch of gaskets. We supply QGER gaskets with material certificates and batch traceability.
Request a quoteWhere our gaskets are used
| Representative image | Gasket / seal | Pharmaceutical / biopharma use | Typical construction | Pharmaceutical applications | Typical standards / specifications |
|---|---|---|---|---|---|
 | Hygienic Sanitary Clamp Gasket (ASME BPE-type static seal) | Product-contact sealing at sanitary clamp connections requiring drainability, cleanability and repeated CIP/SIP exposure. | Precision-molded EPDM, silicone, FKM, FFKM or PTFE sanitary profile matched to the hygienic ferrule/union. | Bioreactors; formulation and buffer skids; purified-water/WFI loops; CIP/SIP systems; sterile transfer lines; product-contact pumps and valves. | ASME BPE-2026 (or project-specified edition) for hygienic bioprocess equipment/static seals; FDA 21 CFR 211.65 and 211.67 at CGMP system level. USP <665>/<1665> may apply to polymeric manufacturing components; USP <87>/<88> may be specified for biological-reactivity qualification. |
 | Pharmaceutical-Grade EPDM Gasket | Cleanable elastomer sealing for hot water, WFI, aqueous process fluids and many CIP/SIP cycles. | Low-extractables peroxide-cured or otherwise pharma-qualified EPDM, molded or precision-cut depending on geometry. | WFI/PW loops; buffer and media preparation; CIP return; non-solvent product transfer; clean-steam condensate interfaces; hygienic valves and pumps. | ASME BPE-2026; FDA 21 CFR 211.65/211.67; USP <665>/<1665> for applicable polymeric manufacturing components. USP <87>/<88> testing may be required by customer material specifications; extractables/leachables qualification is application-specific. |
| Pharmaceutical Silicone / VMQ Gasket | High-purity flexible sealing for hygienic systems, especially where repeated sterilization and wide temperature capability are required. | Platinum-cured or otherwise pharma-qualified silicone/VMQ molded gasket or seal. | Bioreactors; sterile transfer; filtration skids; WFI/PW systems; filling support equipment; CIP/SIP and clean-steam service. | ASME BPE-2026; USP <383> for cured silicone elastomers used in pharmaceutical packaging and manufacturing components where applicable; FDA CGMP 21 CFR 211.65/211.67; customer-specified USP <87>/<88> biological-reactivity requirements. |
| Pharmaceutical FKM / FPM (Viton-type) Gasket | Chemical- and temperature-resistant sealing for solvents, process chemicals and selected SIP/CIP conditions. | Pharma-qualified FKM/FPM molded or cut gasket, compound selected for solvent and sterilization exposure. | Solvent handling; API/intermediate processing; buffer/media systems with aggressive cleaners; selected sterile and high-temperature utility services. | ASME BPE-2026; FDA 21 CFR 211.65/211.67; USP <665>/<1665> where applicable; customer-specified USP <87>/<88> and extractables/leachables qualification. Equipment/OEM specification governs compound compatibility. |
 | High-Purity FFKM / Kalrez-type Gasket | Premium elastomer sealing for highly aggressive solvents, oxidizers, CIP chemicals and demanding high-temperature service. | Perfluoroelastomer (FFKM) molded gasket or O-ring profile, grade selected for chemical resistance and purity. | API synthesis; aggressive solvent/chemical transfer; high-value sterile equipment; critical valve/pump seals; harsh cleaning and sterilization cycles. | ASME BPE-2026 where used in hygienic systems; FDA 21 CFR 211.65; USP <665>/<1665> and customer-specific biological-reactivity/E&L requirements. OEM and compound-vendor data govern sterilization and chemical compatibility. |
 | Virgin PTFE / ePTFE Flat Gasket | Chemically inert sealing for corrosive process fluids, solvents and clean utilities where PTFE purity and low reactivity are advantageous. | Virgin PTFE, filled PTFE or expanded PTFE flat gasket; grade selected for creep resistance and purity. | API chemical processing; clean-utility skids; glass-lined equipment interfaces; filtration; buffer/solvent transfer; nonstandard equipment flanges. | ASME BPE-2026 where within hygienic equipment scope; FDA 21 CFR 211.65; USP <665>/<1665> for polymeric manufacturing components where applicable; ASME B16.21 for standard industrial flat flanges outside hygienic BPE systems. |
| GYLON Restructured PTFE Gasket | Low-creep PTFE-based sealing for aggressive chemicals and pharma process equipment, especially where conventional PTFE cold flow is a concern. | Garlock GYLON restructured PTFE; some grades use inorganic fillers or engineered microstructure; selected by media and purity requirements. | API and solvent processing; glass-lined reactors; chemical transfer; utility/process flanges; specialty pharmaceutical production equipment. | ASME BPE-2026 where accepted in hygienic equipment; FDA CGMP 21 CFR 211.65; USP <665>/<1665> where applicable; manufacturer grade certification and E&L data control product-contact suitability. |
| PTFE Envelope / Filter Gasket | Broad chemical-resistance sealing with a PTFE wetted surface and compressible core; useful for corrosive pharmaceutical and glass-lined equipment. | PTFE envelope around compressed non-asbestos fibre or flexible graphite core; standard or custom geometry. | Glass-lined reactors; filter housings; centrifuge/filter equipment; acid/caustic processing; product vessels; pharmaceutical piping and specialty process equipment. | ASME BPE-2026 where hygienic design requirements apply; FDA 21 CFR 211.65/211.67; USP <665>/<1665> where applicable; equipment/OEM drawings govern proprietary filter and glass-lined equipment geometry. |
| Precision Pharmaceutical O-Rings / Molded Elastomer Seals | Compact static/dynamic sealing in hygienic valves, pumps, instruments and process skids. | Precision-molded EPDM, silicone, FKM or FFKM O-rings and custom profiles; backup rings where required. | Sanitary valves; instrument ports; dosing pumps; filter housings; CIP/SIP skids; bioreactor auxiliaries; filling and transfer equipment. | ISO 3601 for O-ring dimensions/tolerances/quality; ASME BPE-2026 for hygienic-system integration; USP <665>/<1665> and customer-specified USP <87>/<88> where applicable; FDA 21 CFR 211.65. |
 | Sanitary Diaphragm-Valve Seal / Diaphragm | Aseptic product isolation with minimal dead space in diaphragm valves used throughout sterile and high-purity process systems. | PTFE-faced EPDM, modified PTFE, EPDM or other validated polymer diaphragm bonded/reinforced according to valve OEM design. | WFI/PW distribution; sterile process lines; bioreactors; filtration skids; buffer/media preparation; aseptic transfer; CIP/SIP systems. | ASME BPE-2026 for bioprocess diaphragm valves and hygienic design; valve-OEM specification; USP <665>/<1665> for polymeric manufacturing components; FDA 21 CFR 211.65/211.67. Sterile systems may also be governed by site contamination-control strategy/EU GMP Annex 1. |
 | Pharmaceutical Pump Diaphragm | Flexible barrier sealing in diaphragm pumps used for dosing and transfer while isolating process fluid from drive components. | PTFE/ePTFE wetted face bonded to elastomer backing or other OEM-specific high-purity diaphragm construction. | Buffer and media transfer; CIP chemical dosing; API intermediates; chromatography/feed skids; solvent or corrosive chemical dosing; single-use support systems. | Pump-OEM drawing/material specification; ASME BPE-2026 where product-contact hygienic design applies; USP <665>/<1665> for polymeric manufacturing components; FDA 21 CFR 211.65/211.67. |
 | Hygienic / Aseptic Mechanical Seal | Controls leakage at rotating pump or mixer shafts while supporting CIP/SIP, drainability and contamination control. | Single or double mechanical seal with hygienic face materials, cleanable geometry and pharma-qualified secondary elastomers. | Bioreactor agitators; hygienic transfer pumps; WFI/PW pumps; formulation tanks; sterile mixers; CIP/SIP skids and product transfer. | ASME BPE-2026 for hygienic/bioprocess equipment integration; EHEDG GL 25 as hygienic/aseptic mechanical-seal design guidance where specified; pump/mixer OEM requirements; FDA 21 CFR 211.65/211.67. |
 | Pharmaceutical Plate Heat-Exchanger Gasket | Hygienic separation of process and utility streams in gasketed plate heat exchangers used for heating, cooling and heat recovery. | Precision-molded EPDM, FKM, silicone or specialty elastomer perimeter gasket matched to the plate design. | WFI/PW heating/cooling; buffer/media conditioning; product cooling; CIP return; temperature-control loops; non-sterile and sterile process support. | Heat-exchanger OEM drawing/specification; ASME BPE-2026 where hygienic design applies; USP <665>/<1665> and customer-specified biological-reactivity/E&L qualification for product-contact polymeric gaskets; FDA 21 CFR 211.65. |
| Filter Housing / Cartridge-Filter Gasket | Hygienic sealing of filter housings, cartridges and sterile filtration assemblies without bypass or product contamination. | Molded silicone, EPDM, FKM, FFKM or PTFE profile designed to the filter-housing or cartridge groove. | Sterile gas filtration; product filtration; vent filters; buffer/media filtration; WFI/PW filtration; API and formulation filtration systems. | ASME BPE-2026 where within hygienic equipment scope; filter OEM drawing/specification; USP <665>/<1665> for polymeric manufacturing components; customer-specified USP <87>/<88> testing; FDA CGMP 21 CFR 211.65/211.67. |
 | Pharmaceutical Vessel / Manway Gasket | Static hygienic sealing of process-vessel manways, inspection covers and reactor lids that require cleanability and low contamination risk. | Custom-molded or cut PTFE, silicone, EPDM, FKM or PTFE-envelope profile to vessel/manway geometry. | Bioreactors; formulation vessels; API reactors; buffer/media tanks; CIP tanks; product vessels; glass-lined reactor manways. | ASME BPE-2026 for hygienic equipment design; ASME BPVC Section VIII where pressure-vessel boundaries apply; FDA 21 CFR 211.65/211.67; USP <665>/<1665> where applicable; vessel-OEM drawing governs geometry. |
 | High-Purity ePTFE Gasket Tape / Joint Sealant | Form-in-place sealing of large, irregular or low-load equipment flanges where an inert PTFE sealing strip is advantageous. | 100% expanded PTFE tape/cord compressed around a flange or cover; grade selected for purity and creep resistance. | Large process-vessel covers; glass-lined equipment; nonstandard chemical equipment; utility equipment; selected large low-pressure pharmaceutical process flanges after validation. | Equipment/OEM drawing and validated assembly procedure; ASME BPE-2026 where hygienic use is accepted; USP <665>/<1665> for applicable polymeric manufacturing components; FDA 21 CFR 211.65. Use in sterile/product-contact service requires site-specific qualification. |
 | Spiral Wound Gasket - QSW3 / QSW4 (Utilities) | High-pressure/high-temperature sealing for clean steam generation, plant steam, thermal utilities and non-product-contact process piping. | Profiled metallic winding with graphite, PTFE or mica filler; QSW3 outer ring or QSW4 inner and outer rings. | Clean-steam generator utility side; plant steam; thermal-oil systems; compressed gases; boiler/utility skids; pressure equipment and utility headers. | ASME B16.20; ASME B16.5/B16.47; ASME B31.3 for process utilities; ASME BPVC Section VIII where part of pressure equipment. ASME BPE does not replace the applicable metallic-gasket/flange code for standard utility flanges. |
 | Camprofile / Kammprofile Gasket (Utilities / Equipment) | Recoverable severe-service sealing for heat exchangers, pressure equipment and cyclic thermal duties in pharmaceutical utilities and API plants. | Grooved metallic core with graphite or PTFE facing; optional guide ring. | Heat exchangers; clean-utility equipment; API solvent/chemical processing; pressure-vessel nozzles; thermal systems and large equipment flanges. | ASME B16.20 for grooved metal gaskets with covering layers; ASME B16.5/B16.47; ASME B31.3; TEMA where applicable. Product-contact facing material must be separately qualified if exposed to pharmaceutical product. |
 | Metal-Jacketed / Heat-Exchanger Gasket | Custom sealing of shell-and-tube heat exchangers and large equipment where a metallic jacket protects a resilient filler. | Single/double metallic jacket around graphite or other filler; ribbed constructions for pass partitions. | Utility/process heat exchangers; condensers; reboilers; API production heat transfer; clean-utility generation equipment; non-hygienic exchanger interfaces. | ASME B16.20 where applicable; TEMA; ASME BPVC Section VIII for pressure-vessel exchangers; equipment drawing controls geometry. Direct product-contact use requires qualified wetted materials. |
 | Flexible Graphite Gasket / Graphite Packing Ring (Utilities) | High-temperature sealing for steam, thermal utilities, valve bonnets and non-product-contact process equipment. | Flexible/expanded graphite, with or without reinforcement; preformed graphite rings for valve or cover-seal duties. | Plant steam; thermal-oil systems; utility valves; boilers; non-product-contact heat exchangers; API high-temperature auxiliaries. | ASME B16.21 for nonmetallic flat gaskets where applicable; ASME B31.3 at piping-system level; API 622/ISO 15848-1 where valve packing fugitive-emissions qualification is specified. Avoid direct sterile/product-contact use unless specifically validated. |
 | Expansion Joint / Flexible Coupling (Plant Utilities) | Absorbs thermal movement, vibration, pressure surges and misalignment in utility, HVAC and non-product-contact piping/duct systems. | Engineered elastomeric or fabric non-metallic flexible joint with flanged ends; construction selected for media and movement. | HVAC; cooling water; wastewater; utility piping; exhaust/air systems; pump discharge; non-product-contact plant services. | ASTM F1123 for applicable arch-type non-metallic expansion joints; FSA guidance; ASME B31.3 at piping-system level where applicable; utility/OEM specification. Not normally selected for sterile product-contact process lines unless specifically engineered and validated. |
These are typical starting points. Final selection depends on your service conditions and is confirmed with QGER engineering before manufacture.
Points to watch
- Ask for material certificates with your order. We supply them with batch traceability.
- Name every solvent the gasket will see. Some elastomers swell badly in common solvents.
- For hygienic clamp fittings, send the fitting size and standard so we can quote the matching seal.
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