13 MM Butyle Rubber Stopper

Technical Description of Butyl Rubber Stopper

Butyl Rubber Stoppers are high-quality elastomeric closures made from butyl rubber (IIR Isobutylene Isoprene Rubber), widely used in the pharmaceutical, chemical, food, and laboratory industries due to their excellent sealing performance, chemical stability, and low permeability.

1. Material Composition

• Made from halobutyl or bromobutyl rubber, providing superior gas and moisture barrier properties.

• Formulated with stabilizers, curing agents, lubricants, and fillers to enhance durability and elasticity.

• Free from heavy metals and compliant with international pharmaceutical standards (USP, EP, ISO).

2. Key Technical Properties

• High Chemical Resistance: Non-reactive with most pharmaceutical formulations, chemicals, and solvents.

• Low Gas Permeability: Excellent barrier against oxygen, moisture, and gases, ensuring product stability.

• High Elastomeric Recovery: Maintains tight, secure sealing even after multiple punctures.

• Heat Resistance: Suitable for sterilization processes such as

  • Autoclaving

  • Gamma irradiation

  • Ethylene oxide sterilization

• Low Extractables & Leachables: Ensures product purity and prevents contamination.

3. Physical Characteristics

• Hardness (Shore A): Typically ranges between 4060, depending on application.

• Tensile Strength: High tensile strength for durability during repeated usage.

• Compression Set: Low compression set ensures long-lasting sealing integrity.

• Surface Finish: Smooth, non-sticky surface to prevent particle shedding and ease of handling.

4. Design Features

• Available in multiple sizes (13mm, 20mm, 28mm, 32mm, etc.).

• Compatible with various vial neck finishes and aluminum seals.

• Options available:

  • Fluoropolymer-coated stoppers

  • Lyo (lyophilization) stoppers

  • Teflon-coated stoppers

  • Two-leg, three-leg, or center-tear designs

5. Applications

• Pharmaceutical vials (injections, vaccines, antibiotics).

• Chemical reagent bottles.

• Diagnostic kits and laboratory containers.

• Serum bottles, infusion bottles, and freeze-drying vials.

• Food and beverage sealing applications requiring airtight closure.

6. Compliance & Standards

• Complies with USP Class VI, ISO 8871, EP 3.2.9, and FDA guidelines.

• Manufactured in cleanroom environments under GMP conditions.