Medical & Pharmaceutical Gaskets & Seals
Start with the regulated object, then match the grade, joint, process and evidence.
Reusable or hybrid bioprocess equipment, single-use assemblies, medical-device components and facility seals follow different evidence paths. Select the exact grade and fabricated form from the contact route, joint, fluids, pressure and temperature cycle, sterilisation method and required reports. Supplier evidence supports the regulated owner's risk assessment, qualification and validation; it does not replace them.
Choose the Application Boundary First
The same material report can mean different things in reusable process equipment, a single-use assembly, a finished medical device or a cleanroom system. Define the object and compliance owner before comparing compounds.
Reusable or Hybrid Process Equipment
CIP and SIP Interfaces
A hygienic connection exposed to repeated cleaning or sterilisation-in-place belongs to the reusable or hybrid boundary. Record the exact joint, process fluid, full CIP/SIP profile, pressure, compression and maintenance strategy. Compare exact grades using supplier or OEM data; cure chemistry and a compression-set curve do not establish a universal cycle life.
Single-Use Assemblies
Pre-Sterilised Disposable Path
A typical single-use product-contact assembly is qualified for its specified radiation or ethylene oxide process and used once. Steam-capable probes, connectors or adjacent reusable hardware may form a hybrid interface, but they are not the disposable flowpath. Confirm the exact component, assembly bill of materials, sterilisation modality, dose or cycle envelope, packaging, ageing and functional evidence.
Medical-Device Components
Finished-Device Risk Assessment
Material-level USP <88> or ISO 10993 endpoint data may support a device assessment, but the device manufacturer must address the finished device, contact type and duration, processing, residues, sterilisation and all relevant biological endpoints. Food-contact declarations are supplementary only when an actual food-contact use is also in scope.
Facility and Cleanroom Seals
Doors, Panels, Housings and Ducts
ISO 14644-1:2015 classifies the cleanroom or zone by airborne particle concentration; it does not approve a gasket or set a generic VOC limit. If a seal is implicated, investigate the complete airflow and containment system. Specify leakage, compression recovery, cleanability, shedding, chemical emissions, adhesive, disinfectant and fire criteria, then requalify the affected system.
Evidence Inputs for Regulated Selection
Reusable CIP and SIP Inputs
Record the exact joint and OEM basis, process fluid, cleaner formulation, time, temperature, pressure, steam quality, cooling, compression and cycling. Platinum-cured silicone, other silicone grades, EPDM, PTFE-based constructions and FFKM may enter a shortlist, but cure system or polymer family does not establish product contact or service life.
Extractables vs. Leachables
Extractables are substances released under defined laboratory conditions; leachables migrate under actual or simulated use. The protocol must identify the exact specimen and processing state, solvents, time, temperature, methods, thresholds and traceability. USP <661>/<661.1>/<661.2> and <1663>/<1664> primarily concern packaging and delivery contexts. USP <665>/<1665> may be more relevant to plastic manufacturing components and systems, subject to project applicability.
Sterilisation Evidence
State the modality, exact item or assembly, dose or cycle envelope, maximum exposures, packaging, ageing or shelf life and functional result. ISO 11137-1:2025 concerns radiation sterilisation process validation and control; ISO 10993-7:2026 addresses EO and ECH residual limits for relevant EO-sterilised devices or components; ISO 17665:2024 concerns moist-heat sterilisation processes. None is a generic silicone approval or universal SIP-life test.
Documentation Boundary
Documentation varies by manufacturer, grade, fabricated form and order. Before specification, define the required lot-linked Certificate of Compliance, material declaration, test reports, E&L study, sterilisation information and sample-to-supplied-item traceability. Put any change-notification obligation and notice period in the quotation or quality agreement; do not assume blanket application.
Screening Candidates by Exact Grade and Form
A family name or the label ‘pharmaceutical grade’ is not a specification. Confirm the exact manufacturer, compound or resin, fabricated form, contact route, joint, process envelope, sterilisation state and evidence required by the regulated owner.
Selected platinum-cured or other silicone compounds may suit product-contact, device or thermal-cycling duties. Check formulation, post-cure, E&L data, steam performance, sterilisation state and the report's traceability to the finished seal.
Qualified EPDM compounds may suit hot water, steam or alkaline cleaning. Confirm the exact formulation, all cleaners and concentrations, temperature, duration, pressure, joint and evidence. USP <88> or food-contact reports apply only to the tested article and stated scope.
PTFE-based constructions may suit broad chemical or WFI duties. Check the exact resin and fillers, fabrication, seam or envelope construction, creep and load retention, joint design, process-specific E&L package and qualification requirements.
An FEP or PFA jacket surrounds an elastomer core. Check the jacket, core, seam or construction, compression, permeation, temperature, pressure, motion and recovery limits. Do not describe the assembly as PTFE-encapsulated when the jacket is FEP or PFA.
FFKM is a family of specialised compounds, not one chemical or temperature rating. Select an exact grade and part form from the complete fluid, cleaner, temperature, pressure, joint, cycling and evidence envelope.
Closed-cell EPDM, silicone and other foams may suit doors, panels, housings or ducts. Select an exact product using leakage, compression recovery, cleanability, shedding, chemical emissions, adhesive, disinfectant and fire-performance criteria.
Specify the exact component and finished assembly against the supplier's sterilisation modality, dose or cycle range, maximum exposure, packaging, ageing, shelf life and functional evidence. ISO 11137 process evidence or ISO 10993-7 residual data applies only where its actual scope is met.
Follow the equipment OEM and validated seal specification for profile, material, vacuum or leak criterion, cleaning and sterilisation. Shelf or condenser setpoints are not automatically the door-seal temperature, and no polymer family establishes a universal cycle life.
What Each Framework Applies To
These frameworks apply to different test articles, devices, equipment systems, organisations and regulated manufacturers. Confirm applicability, the governing edition and the evidence for the exact proposed item; the regulated owner remains responsible for supplier qualification and validation.
USP <88> and Legacy Class VI Reports
USP <88> provides in-vivo biological-reactivity testing for a defined test article in stated pharmaceutical packaging or combination-product contexts. A legacy Class VI report can be useful evidence, but check the edition, specimen, extraction conditions, endpoints and traceability. It is not complete pharmaceutical-process or medical-device approval.
ISO 10993-1:2025
ISO 10993-1:2025 governs biological safety evaluation of a medical device within risk management, normally centred on the finished device, contact type and exposure. Material endpoint data may support that work but cannot replace it. USP <88> and ISO 10993 evidence are complementary, not interchangeable.
USP Water and E&L Chapters
USP <1231> is informational pharmaceutical-water-system guidance, not a gasket extractables standard. USP <661>/<1663> primarily concern packaging and delivery contexts. USP <665>/<1665> may be more relevant to plastic manufacturing components and systems, but applicability and the project E&L protocol still control.
Food-Contact Provisions
21 CFR 177.2600, 21 CFR 177.1550 and Regulation (EU) 10/2011 address defined food-contact articles or materials. They may be supplementary evidence for an actual dual-use food-contact component, but they do not establish pharmaceutical-process, medical-device or TGA approval.
ASME BPE Project Requirements
ASME lists BPE-2026 as current. State the project-specified edition and verify the applicable wording in the licensed edition. Keep metallic product-contact surface finish, seal geometry, polymer documentation and E&L as separate submittals; metallic SF grades do not become elastomer-gasket finish grades. Certification or marking requires the exact certificate-holder scope.
AS ISO 13485:2017
AS ISO 13485:2017 adopts ISO 13485:2016 for medical-device quality management systems. Supplier CoCs, lot records, test reports and change information can support controls defined in the device manufacturer's QMS. The standard does not certify a gasket material.
TGA, PIC/S and Medical Devices
For in-scope Australian manufacture of medicines, active pharmaceutical ingredients and sunscreens, TGA applies PIC/S PE009-17 from 1 September 2025 unless exempt. Medical devices follow conformity-assessment and Essential Principles pathways. In both cases the regulated organisation owns supplier qualification, validation and change control; TGA does not confer a generic material status on a gasket.
EU GMP Annex 1
EU GMP Annex 1 governs sterile medicinal-product manufacture and its contamination-control strategy. Equipment, vendor approval, maintenance, single-use sterilisation evidence and change assessment may place requirements on a seal, but Annex 1 does not certify the material.
ISO 14644-1:2015
ISO 14644-1:2015 classifies a cleanroom or clean zone by airborne particle concentration. It does not classify a gasket, set a generic VOC limit or establish failure cause. Leakage, shedding, chemical emissions and material suitability need separate product data, project criteria and system qualification.
21 CFR 211.65
For in-scope drug manufacturing, 21 CFR 211.65 requires product-contact equipment surfaces not to be reactive, additive or absorptive so as to alter drug safety, identity, strength, quality or purity. It prescribes no gasket family or certificate; the manufacturer must qualify the actual equipment surface and use.
For an actual food-contact use, keep its declarations and site controls separate from pharmaceutical or device qualification. See our Food & Beverage industry page.
Products for Pharmaceutical & Medical Applications
These links are broad catalogue categories, grouped by application boundary. A category link does not establish regulated-use evidence for its listed variants; confirm the exact grade, form, contact route and report set for the quoted item.
Engineering Guides for Pharmaceutical Sealing
Reference tools and guides to support gasket screening, inspection and measurement for pharmaceutical and medical-device manufacturing.
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Define the Regulated Object Before Quotation
Send the process fluid, contact route, joint drawing, temperature and pressure cycle, cleaning or sterilisation conditions and evidence list. We will record what must be confirmed for engineering and quality review.
- Exact grade and fabricated form identified
- Reports checked for specimen, conditions, edition and traceability
- Qualification and validation remain with the regulated owner
Disclaimer
This page is provided for general engineering reference only and does not constitute professional advice, specification, or guarantee of performance. Actual results depend on specific application conditions. Universal Gaskets Pty Ltd accepts no responsibility or liability for decisions made based on this information. For full terms, see our Terms & Conditions.
Temperature ranges, chemical resistance ratings, and mechanical properties cited on this page are typical values for standard grades. Actual performance varies with compound formulation, filler package, and service conditions — contact us to confirm suitability for your specific application.