Pharmaceutical Rubber Stopper Manufacturer – Butyl & Bromobutyl

13 mm and 20 mm butyl, bromobutyl and coated stoppers for vials, supplied plain or ready-to-use.

Butyl and bromobutyl rubber stoppers for pharmaceutical vials, including pre-sterilized RTU options. USP/EP compliant, ISO 5 cleanrooms, custom sizes.

PharGlass is a pharmaceutical rubber stopper manufacturer supplying butyl, bromobutyl and coated stoppers for glass vials, cartridges and diagnostic containers. Stoppers are produced from pharmaceutical-grade elastomer compounds, moulded to tight dimensional tolerances and washed under controlled conditions. We supply plain stoppers for in-house sterilization as well as pre-sterilized ready-to-use stoppers for aseptic filling lines.

Butyl or bromobutyl?

Bromobutyl stoppers offer excellent moisture and oxygen barrier properties and are the standard choice for lyophilized products, antibiotics and vaccines. Butyl stoppers provide good chemical resistance at a lower cost and are widely used for oral liquids, diagnostics and general injectables. Chlorobutyl and silicone options are available for specific drug compatibility requirements.

For biologics and sensitive compounds, a film-coated stopper (PE or PTFE) creates a barrier between the drug and the elastomer, reducing extractables and improving compatibility. We can recommend a coating based on your drug formulation and sterilization method.

Stopper sizes and specifications

Neck sizeElastomerCoatingTypical use
13 mmButyl / bromobutylUncoated or PE coated2 ml to 5 ml vials, small-dose injectables
20 mmButyl / bromobutylUncoated, PE or PTFE coated5 ml to 50 ml vials, lyophilization, vaccines
13 mmSiliconeUncoatedDiagnostics, specialty applications
20 mmBromobutylPTFE filmBiologics, monoclonal antibodies

Stoppers are supplied in nested bags or in ready-to-use nests and tubs. Custom dimensions, hardness and colour matching are available for OEM projects.

Container closure compatibility

A stopper only performs correctly when it matches the vial neck and the cap. We supply sterile glass vials and aluminium-plastic flip-off caps alongside stoppers, so the full system can be dimensionally checked and sterilized as a set.

Quality and documentation

USP <381> testingElastomer identity and physicochemical testing according to USP and EP requirements.
Extractables supportMaterial composition and coating information available for your E&L studies.
Cleanroom washingWashed and dried in a controlled environment, with pre-sterilized options available.
Batch traceabilityCompound lot, moulding date and sterilization cycle recorded for each batch.

FAQ

Frequently asked questions

What is the difference between butyl and bromobutyl stoppers?

Bromobutyl has better moisture and oxygen barrier performance and is preferred for lyophilized and oxygen-sensitive drugs. Butyl is a lower-cost option with good chemical resistance for general injectables and diagnostics.

Are your stoppers supplied ready-to-use and sterilized?

Yes. We supply plain stoppers for in-house sterilization and pre-sterilized ready-to-use stoppers in nests and tubs for aseptic filling lines.

Which vial sizes and neck finishes do your stoppers fit?

Standard 13 mm and 20 mm neck finishes for vials from 2 ml to 50 ml. Custom dimensions can be developed for non-standard vials and cartridges.

Can you match cap colours to our label?

Yes. Flip-off caps can be supplied in standard or custom colours with hot-stamped logos, so the cap and label can be matched.

Do you provide extractables and leachables documentation?

We provide material composition, coating details and test reports to support your extractables and leachables assessment. Study protocols should be agreed with your quality team.

Ready to Start Your Project?

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