INDUSTRY COMPONENT

Rubber Stopper

A rubber stopper is a pharmaceutical-grade sealing component designed to create an airtight, sterile barrier for vials containing injectable medications.

Component Specifications

Definition
A rubber stopper is a critical elastomeric closure component used in pharmaceutical vials to maintain sterility, prevent contamination, and ensure product integrity during storage and transportation. It forms a hermetic seal when compressed between the vial neck and aluminum crimp cap, protecting sensitive liquid or lyophilized drugs from environmental factors while allowing sterile needle penetration for administration.
Working Principle
The rubber stopper functions through elastic deformation and compression sealing. When inserted into the vial neck and secured with an aluminum crimp, it creates a tight barrier that prevents microbial ingress, maintains vacuum or inert gas headspace, and allows multiple punctures while resealing automatically due to its elastic memory properties.
Materials
Pharmaceutical-grade elastomers: Bromobutyl rubber (most common for chemical resistance), Chlorobutyl rubber (enhanced moisture barrier), Synthetic polyisoprene (high purity), Silicone rubber (for lyophilized products). All materials must meet USP Class VI and EP 3.1.9 standards for biocompatibility.
Technical Parameters
ParameterTypical rangeNotes & selection driver
Diameter13-32 mm (standard vial sizes)
Durometer40-50 Shore A
Thickness2.5-4.0 mm
Extractables< 5 μg/mL per USP <1663>
SterilizationGamma irradiation (25-40 kGy) or autoclaving
Coring Resistance≤ Category 2 per ISO 8871
Self Sealing Capability≥ 20 punctures with 16G needle

Ranges are indicative industry figures for RFQ preparation, not a supplier commitment. Confirm every value and standard with the legal manufacturer before ordering.

Standards
ISO 8871, ISO 8362, USP <381>, EP 3.2.9, FDA 21 CFR 211

Parent Products

This component is used in the following industrial products

Engineering Analysis

Risks & Mitigation
  • Extractable/leachable contamination
  • Coring during needle insertion
  • Incomplete seal leading to sterility breach
  • Material-drug incompatibility
  • Particulate generation
FMEA Triads
Trigger: Inadequate compression during crimping
Failure: Leakage and loss of sterility
Mitigation: Implement torque-controlled crimping machines with regular calibration and visual inspection systems
Trigger: Material degradation from drug interaction
Failure: Extractable contamination and product recall
Mitigation: Conduct comprehensive compatibility studies per USP <1664> and maintain material certificates

Industrial Ecosystem

Compatible With

Typical Suppliers & Equivalents

Compliance & Inspection

Tolerance
±0.2 mm diameter, ±0.1 mm thickness per ISO 8362
Test Method
USP <381> elastomeric closures, ISO 8871 extractables, ASTM D3577 compression set

Procurement Evaluation Criteria

A practical evidence checklist for RFQ preparation and supplier evaluation.

Technical documentation
Request current drawings, revision history, and a signed specification sheet.
Manufacturing capability
Verify equipment lists, process limits, capacity, and representative production evidence.
Inspection readiness
Confirm test methods, calibrated equipment, sampling plans, and traceable reports.
Supplier transparency
Check the legal entity, factory address, ownership, certifications, and direct contacts.

CNFX does not score or rank suppliers. Buyers must verify all claims and documents with the legal manufacturer before ordering.

Manufacturers of Rubber Stopper

9 companies list this product among what they make. Company figures are quoted from each company's own website; every card states where the relationship came from.

Guangdong Zhongxiang New Materials Co., Ltd. (ZYX Rubber)
Guangzhou, Guangdong, CN
ISO 9001:2015 IATF 16949
Listed on the company's own website · profile compiled by CNFX from public sources
Listed there as: “Rubber Stopper”
View source page ↗ zyxrubber.com · checked 2026-08-26
Hangzhou Bright Rubber Plastic Product Co., Ltd.
Hangzhou, Zhejiang, CN
ISO 9001:2015 IATF 16949
Listed on the company's own website · profile compiled by CNFX from public sources
Listed there as: “Rubber Stopper”
View source page ↗ rubberplasticparts.com · checked 2026-08-26
CHANGZHOU WQS PHARMACEUTICAL PACKAGING CO., LTD
Jiangsu, CN
Also makes: Pharmaceutical Vials
Listed on the company's own website · profile compiled by CNFX from public sources
Listed there as: “Caps Rubber Stoppers Series”
View source page ↗ wqsglass.com · checked 2026-09-01
Lindas
Fujian, CN
Listed on the company's own website · profile compiled by CNFX from public sources
Listed there as: “Rubber Stopper”
View source page ↗ lindasrubber.com · checked 2026-08-30
Qingdao Huaren Medical Product Co., Ltd.
Qingdao, Shandong, CN
Listed on the company's own website · profile compiled by CNFX from public sources
Listed there as: “Rubber Stopper for Injection”
View source page ↗ sinohrpp.com · checked 2026-09-03
Qingdao Todo Rubber Co.,LTD
Qingdao, Shandong, CN
Listed on the company's own website · profile compiled by CNFX from public sources
Listed there as: “Rubber stoppers”
View source page ↗ todorubber.com · checked 2026-09-11
Shijiazhuang Beike Sealing Technology Co.,Ltd.
Shijiazhuang, Hebei, CN
Listed on the company's own website · profile compiled by CNFX from public sources
Listed there as: “Custom Rubber Stopper”
View source page ↗ beikesealing.com · checked 2026-09-04
Taian Youlyy Industrial Co., Ltd.
Shandong, CN
Also makes: Pharmaceutical Vials
Listed on the company's own website · profile compiled by CNFX from public sources
Listed there as: “Rubber Stopper”
View source page ↗ youlyy.com · checked 2026-09-01
Xiamen Better Silicone Rubber Co., Ltd.
Xiamen, Fujian, CN
Listed on the company's own website · profile compiled by CNFX from public sources
Listed there as: “Rubber Stoppers”
View source page ↗ better-silicone.com · checked 2026-09-05

Manufacturer listings support early research and capability understanding. They are not certification, ranking, or transaction guarantees.

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Frequently Asked Questions

What is the difference between bromobutyl and chlorobutyl rubber stoppers?

Bromobutyl offers superior chemical resistance against aggressive drug formulations, while chlorobutyl provides better moisture barrier properties for hygroscopic products. Selection depends on drug compatibility testing.

How many times can a rubber stopper be punctured before leaking?

High-quality stoppers withstand 20+ punctures with 16G needles while maintaining seal integrity, though single-use is recommended for sterility. ISO 8871 defines coring resistance categories.

Data Basis

Editorial classification, named public sources where available, and source-reviewed manufacturer records. See the editorial policy.

Preliminary Technical Classification
This page supports structured research, RFQ preparation, and supplier evaluation. It does not replace buyer-led supplier qualification, standards review, or technical approval.

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