20mm Butyl Vial Rubber Stopper
The 20mm Butyl vial rubber stopper is an essential component in the manufacturing and storing of pharmaceuticals. This high-quality stopper is made with industry-leading materials that ensure a secure and safe seal for your products.
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Description
20mm butyl vial rubber stopper · OTR · WVR · extractables
USP <381> · ISO 8362-5 · Quality Assurance
20mm butyl vial rubber stopper · high-purity chlorobutyl rubber stoppers · chemical parameters
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20mm Butyl Vial
Rubber StopperOTR · WVR · Extractables Testing · USP <381> · ISO 8362-5 · Quality Assurance
High-purity chlorobutyl / bromobutyl rubber stopper · full chemical parameter documentation · pharmacopoeial compliant
|
20mm Standard size |
OTR documented O₂ transmission rate |
WVR documented Water vapour rate |
Extractables Tested & reported |
USP <381> Compliant ★ |
ISO 8362-5 Compliant ★ |
CHEMICAL PARAMETERS - BARRIER PROPERTIES
OTR, WVR, and extractables - the three critical chemical parameters
For a pharmaceutical vial rubber stopper, three chemical parameters directly determine whether the stopper protects the product through its shelf life: how much oxygen can pass through, how much moisture can pass through, and what chemical species the stopper releases into the product. All three are tested and documented for this stopper.
OTR
very low
Oxygen Transmission Rate
O₂ barrier · headspace protection
OTR measures how much oxygen passes through the stopper material per unit area and time. A very low OTR protects the product against oxidative degradation - critical for oxygen-sensitive injectable formulations including certain biologics, lipid emulsions, and reduced compounds. Bromobutyl and chlorobutyl rubbers have inherently low OTR compared to other elastomers due to their halogenated isobutylene backbone.
WVR
very low
Water Vapour Transmission Rate
Moisture barrier · lyophilized powder protection
WVR (also called MVTR - moisture vapour transmission rate) measures how much water vapour passes through the stopper. This is the defining parameter for freeze-dried and powder vials where moisture ingress directly threatens product stability - even very small moisture increases in a lyophilized cake can accelerate degradation. Butyl rubber offers the lowest WVR of common pharmaceutical elastomers, making it the standard choice for powder and lyophilized product closures.
EXTRACTABLES
low
Total Organic & Inorganic Extractables
Leachable precursors · patient safety basis
Extractables are chemical entities that can be released from the stopper material into the contacting product - either during storage (leachables) or under accelerated extraction conditions (extractables study). They are identified and quantified using GC-MS, LC-MS, and ICP-MS analytical methods. The extractable profile of this stopper is documented per USP <381> / EP 3.2.9 conditions and provides the basis for formulation-specific leachables risk assessment.
Extractables testing - key parameters reported
The following parameters are reported in the extractables test documentation provided with this stopper.
| Extractable parameter | Test method | Typical result (illustrative) | Pharmacopoeial limit basis |
|---|---|---|---|
| Total organic extractables | GC-MS / LC-MS | Low - within limit | USP <381> / EP 3.2.9 extractables criterion |
| Heavy metals (Pb, Cd, Hg, As) | ICP-MS | Below detection / trace | ICH Q3D elemental impurity limits |
| Zinc (Zn) | ICP / AAS | Low ppm range | USP <381> heavy metals test |
| Antioxidant residues | HPLC / UV | Trace - documented | Formulation-specific risk assessment basis |
| Vulcanisation residues | GC-MS | Trace - documented | Rubber compound-specific characterisation |
| pH of aqueous extract | Potentiometry | Within ±1 of blank | USP <381> pH test |
| Colour of extract | Visual / colorimetry | Passes | USP <381> colour test |
| Reducing substances | Titration | Within limit | USP <381> reducing substances |
Request the full extractables dataset for your specific stopper formulation
The illustrative data above represents typical values for this stopper category. Actual extractables results vary by specific elastomer compound, batch, and test conditions. We supply a compound-specific extractables report - identifying all detected species, quantified against ICH Q3D and pharmacopoeial limits - on request for formulation compatibility assessment and regulatory submission support. Contact us with your product type and intended use for the most relevant dataset.
qUALITY STANDARD - PHARMACEUTICAL COMPLIANCE
USP <381> and ISO 8362-5 - what each standard requires from this stopper
Two pharmacopoeial and international standards govern rubber closures for injectable vials. This stopper is tested and documented against both - allowing it to support regulatory submissions in both the US and international markets referencing the ISO framework.
Elastomeric Closures for Injections
United States Pharmacopeia · general chapter
USP General Chapter <381> covers physicochemical and functional testing of elastomeric closures (rubber stoppers) for injectable products. It defines the test methods and acceptance criteria for the primary quality attributes of the stopper as a primary packaging material in contact with an injectable drug product.
Physicochemical tests (pH, colour, reducing substances, heavy metals, extractable Zn)
Biological reactivity tests (USP Plastics Class VI basis)
Functional tests: self-sealing capacity after needle puncture
Fragmentation test: no rubber fragments after coring
rubber closures for injection vials
International Organization for Standardization
ISO 8362-5 is the companion closure standard to the ISO 8362 glass vial series - specifying requirements for rubber closures intended for use with injection vials manufactured to ISO 8362-1 (moulded) and ISO 8362-2 (tubular). It covers dimensional tolerances, physicochemical tests, and functional performance closely aligned with, though not identical to, USP <381>.
Dimensional tolerances for 20mm vial neck fit (matched to ISO 8362-2)
Physicochemical tests (aqueous extract, pH, absorbance, reducing substances)
Penetrability and fragmentation performance
Aligned to EU and international regulatory expectations
Dual compliance simplifies multi-market regulatory submissions
Products sold in both the US (FDA jurisdiction, USP) and international markets (many of which reference ISO standards) benefit from a stopper that is tested and documented against both frameworks. Rather than qualifying one stopper for the US market and a different specification for other markets, a dual-compliant stopper provides a single qualification dataset applicable across both regulatory environments.
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QUALITY ASSURANCE
Quality Assurance - what we test, document, and deliver per batch
Quality assurance for a pharmaceutical rubber stopper extends beyond the final product test - it covers raw material control, in-process monitoring, finished goods inspection, and documentation delivery. Here is the complete QA framework applied to every production batch of this stopper.
I
Raw material control
Incoming inspection · compound traceability
Every batch of elastomer compound entering production is tested against a defined raw material specification - including compound identification (IR spectroscopy or similar), hardness confirmation, and supplier CoA review - before release to the production floor. Raw material batch traceability is maintained through the finished stopper CoA.
II
In-process controls
Moulding parameters · dimensional checks
Critical moulding parameters (temperature, pressure, cure time) are monitored and logged throughout each production run. In-process dimensional sampling verifies that the stopper's plug head diameter, skirt depth, and overall height remain within specification - identifying process drift before it produces out-of-spec finished product.
III
Finished goods testing
USP <381> / ISO 8362-5 · per-batch test
Each finished production batch is tested against the applicable pharmacopoeial and physical specification before release - physicochemical tests (USP <381> / ISO 8362-5), functional tests (self-sealing, fragmentation), dimensional measurements, and visual inspection. No batch is released without a completed, passed test record.
Documentation delivered with every batch
Certificate of Analysis (CoA) - lot-specific test results
USP <381> physicochemical test results (pH, colour, Zn)
ISO 8362-5 dimensional conformance record
Self-sealing / fragmentation test result
Raw material batch traceability reference
Extractables dataset - compound-level (on request)
OTR / WVR permeability data (compound-level, on request)
Regulatory support letter / DMF reference (on request)
COMPLETE SPECIFICATIONS
20mm butyl vial rubber stopper - full specification reference
Reference specifications for the 20mm high-purity chlorobutyl / bromobutyl rubber stopper, including chemical parameters and quality standard references.
| Parameter | Chemical & performance | Standard / method |
|---|---|---|
| Material | ||
| Elastomer type | Bromobutyl / chlorobutyl ★ | High-purity compounding |
| Hardness | 40–55 Shore A | ISO 48 / ASTM D2240 |
| Size | 20mm | ISO 8362-5 |
| Chemical parameters | ||
| OTR (Oxygen Transmission Rate) | Very low - bromobutyl class ★ | ASTM D3985 / ISO 15105 |
| WVR (Water Vapour Trans. Rate) | Very low - lowest of common pharma elastomers ★ | ASTM E96 / ISO 15106 |
| Extractables - organic | Low - within pharmacopoeial limits | USP <381> / EP 3.2.9 |
| Extractables - heavy metals | Below detection / trace (ICP-MS) | ICH Q3D / USP <381> |
| pH of aqueous extract | Within ±1 of blank water | USP <381> pH test |
| Quality standards compliance | ||
| US standard | USP <381> ★ compliant | United States Pharmacopeia |
| International standard | ISO 8362-5 ★ compliant | ISO international |
| Biocompatibility basis | USP Plastics Class VI | Biological reactivity tests |
| Documentation | ||
| Batch documentation | CoA + test results per lot | QA release |
| Extended data | OTR / WVR / E&L dataset - on request | - |
| Regulatory support | DMF reference / support letter - on request | - |
WHO ORDERS THIS STOPPER
High-purity butyl vial stoppers - across the pharmaceutical supply chain
The 20mm butyl vial rubber stopper with full chemical parameter documentation is specified wherever regulatory submissions or formulation risk assessment requires evidence beyond the basic CoA.
regulatory affairs teams
NDA / MAA dossier support
Regulatory affairs teams building container/closure system sections of drug marketing authorisation applications - needing OTR, WVR, and extractables data to support their packaging justification.
formulation & stability teams
Leachables risk assessment
Formulation scientists conducting extractables/leachables risk assessment for their specific product - using the compound-level extractables dataset to identify and evaluate potential leachable species against ICH Q3D limits.
lyophilized product manufacturers
WVR-critical - powder moisture protection
Manufacturers of freeze-dried and lyophilized powder products for whom WVR (moisture vapour transmission) is the primary closure selection criterion - ensuring multi-year dry powder shelf stability.
biologics & biosimillar producers
OTR-critical · oxidation-sensitive formulations
Biologics producers with oxygen-sensitive formulations - proteins, antibodies, or lipid-based products where oxidative degradation is a stability risk - requiring documented low-OTR closure performance.
CDMOs with multi-market clients
US + international dual compliance
Contract manufacturers supporting clients with products marketed in both US (USP) and international (ISO) markets - where a dual-compliant stopper avoids sourcing two different specifications for the same product.
quality assurance & supplier qualification
Audit-ready documentation
QA and procurement teams conducting supplier qualification audits - needing complete, audit-ready chemical parameter and standards compliance documentation from a single supplier contact.
Low OTR. Low WVR. Low Extractables.
Full chemical data. Dual-standard compliant.
Request a free sample of the 20mm butyl vial rubber stopper with full chemical parameter data - OTR, WVR, and extractables dataset - for your formulation compatibility and regulatory submission needs.
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