| Base Elastomer | Nitrile butadiene rubber, commonly identified as NBR or nitrile rubber. | Use a clearly identified NBR compound with a defined acrylonitrile content, hardness grade, cure system, and batch traceability. | Material specification, compound identification, technical data sheet, and batch or lot record. | Compound identity and production traceability must be documented before approval. |
| Oil and Fuel Resistance | NBR is generally selected for resistance to mineral oils, greases, and many petroleum-based fluids. | Confirm compatibility with the actual fluid, concentration, pressure, temperature, and exposure duration. Do not use generic NBR resistance claims as the sole qualification. | Fluid-compatibility chart plus application-specific immersion or seal-performance test data where required. | Acceptance should be based on measured volume change, hardness change, leakage, and dimensional stability. |
| Temperature Capability | Typical NBR service limits depend on compound formulation, hardness, geometry, and operating conditions. | A commonly used general design range is approximately -30 °C to +100 °C; some formulations may provide different limits. | Compound-specific temperature rating, aging test results, and application validation. | Use the supplier’s compound-specific limits rather than applying one temperature range to every NBR seal. |
| REACH | Regulation (EC) No 1907/2006. Requirements may include substance restrictions and communication of Substances of Very High Concern (SVHCs). | Finished seals and kit components should be reviewed for restricted substances and SVHC communication obligations applicable to the supplied articles. | REACH declaration, current SVHC screening or analytical statement, and supply-chain substance information when applicable. | Supplier declaration required |
| RoHS | Directive 2011/65/EU and applicable amendments restrict specified substances in electrical and electronic equipment. | RoHS status is relevant when the seal kit is supplied as part of, or for use in, covered electrical or electronic equipment. It is not automatically applicable to every standalone seal. | RoHS declaration and, where requested, material composition or test evidence for restricted substances. | Confirm product scope |
| FDA 21 CFR 177.2600 | U.S. regulation for rubber articles intended for repeated use, including extractives limits under specified test conditions. | Use only a formulation specifically developed and documented for the intended food-contact application. General industrial NBR must not be represented as FDA-compliant without evidence. | Food-contact compliance declaration, formulation or raw-material control statement, and applicable extraction test report. | Application-specific evidence |
| EU 1935/2004 | Framework Regulation (EC) No 1935/2004 for materials and articles intended to come into contact with food. | Food-contact suitability must be assessed for the intended food type, contact conditions, temperature, duration, and migration risk. | Declaration of compliance where applicable, migration or overall-migration assessment, traceability information, and conditions of use. | Food-contact assessment required |
| EU Food-Contact GMP | Regulation (EC) No 2023/2006 requires good manufacturing practice for materials and articles intended for food contact. | Production should be controlled to prevent contamination, mix-ups, and loss of traceability during compounding, molding, trimming, cleaning, and packing. | Quality-management records, manufacturing controls, hygiene procedures, and batch traceability documents. | Verify manufacturing controls for food-contact orders. |
| Dimensional Accuracy | Seal dimensions must match the applicable drawing, groove design, and tolerance requirements. | Specify inside diameter, outside diameter, cross-section, profile, tolerance, flash limits, and allowable deformation. | Approved drawing, dimensional inspection report, sampling plan, and calibrated measurement records. | Critical dimensions must be verified by lot or according to the agreed inspection plan. |
| Hardness | Elastomer hardness is commonly reported as Shore A in accordance with an applicable hardness-testing method. | Define the target hardness and tolerance, for example 70 Shore A ± 5 Shore A, only when suitable for the seal design. | Hardness test report, test method, sample conditioning, and lot identification. | Hardness must be confirmed on representative production samples. |
| Compression Set | Compression set indicates the material’s tendency to retain deformation after compression and thermal exposure. | Select a compound and design that provide acceptable sealing force retention at the actual temperature and service duration. | Compression-set test report using the agreed standard, temperature, duration, specimen type, and acceptance limit. | Lower compression set is generally preferred for long-term static sealing, but the limit must be application-defined. |
| Peroxide or Sulfur Cure | Cure chemistry affects heat resistance, compression set, chemical compatibility, and extractables. | Specify the cure system when it influences food-contact status, temperature performance, or compatibility with the operating medium. | Controlled formulation record, change-control declaration, and relevant physical or extractables testing. | Any formulation change should require prior notification and requalification when relevant. |
| Surface and Visual Quality | Sealing surfaces should be free from defects that could create leakage or contamination. | Control flash, mold marks, cuts, cracks, blisters, inclusions, porosity, sticking, and particulate contamination. | Visual inspection standard, defect limit samples, inspection records, and cleanliness procedure. | Define visual acceptance criteria before mass production. |
| Kit Configuration | A seal kit may contain multiple seal profiles, backup rings, washers, or installation accessories. | Each component should have a part number, material designation, quantity, revision level, and installation position. | Bill of materials, packing list, component identification, assembly drawing, and revision-controlled instructions. | Mixed-component kits should include clear identification to prevent installation errors. |
| Packaging and Storage | Elastomer storage conditions influence aging, ozone exposure, deformation, and contamination risk. | Package seals to protect them from direct sunlight, ozone-generating equipment, heat, moisture, and mechanical deformation. | Storage instruction, packaging specification, production date or lot code, and shelf-life statement based on the compound and packaging method. | Use first-in, first-out inventory control and inspect aged stock before installation. |
| Traceability | Traceability supports regulatory communication, product recalls, nonconformance investigation, and change control. | Every kit should be traceable to the material batch, molding batch, inspection record, packing date, and applicable specification revision. | Lot code, certificate of conformity, inspection report, and retained production records. | Full lot traceability is recommended for global distribution. |
| Change Management | Changes to formulation, raw materials, tooling, manufacturing site, or critical process parameters can affect compliance and performance. | Require advance notification for changes that may alter dimensions, extractables, chemical resistance, hardness, or regulatory status. | Change-notification procedure, revised declarations, requalification plan, and updated technical documents. | No unapproved material or process substitution. |