Butyl Rubber Stopper

20 mm Butyl Rubber Stopper – RFU (Ready For Use)

Sterile | Aseptic | High Barrier Protection

Product Overview:
Our 20 mm Butyl Rubber Stopper – RFU (Ready For Use) is a pre-washed and sterilized closure solution designed for use in aseptic pharmaceutical filling. Made from premium bromobutyl or chlorobutyl rubber, it provides excellent sealing, low extractables, and superior resistance to moisture and gas transmission. The RFU stopper is supplied sterile and double-packed, ready to be used directly in cleanroom operations.

Key Features:

• Size: 20 mm (suitable for ISO standard 20 mm neck glass vials)

• Material: Pharmaceutical-grade Butyl Rubber (Bromobutyl or Chlorobutyl)

• Type: RFU – Ready For Use (Pre-washed, depyrogenated, gamma-sterilized)

• Sterilization: Terminal sterilization via Gamma Irradiation (typically 25–40 kGy)

• Design Options:

  • Injection type – for liquid formulations

  • Lyophilization type – for freeze-dried products

  • Slitted or Non-slitted options available

• Color: Standard grey or custom colors available on request

Applications:

• Aseptic filling of:

  • Vaccines and insulin

  • Antibiotics and oncology products

  • Hormonal, biological, and biotech injectables

• Suitable for both liquid and lyophilized (freeze-dried) drug products

Packaging:

• Double sterile polybag packaging in ISO Class 7 cleanroom

• Suitable for direct introduction into Grade A/B areas

Regulatory & Quality Standards:

• Complies with:

  • USP <381>, <382>

  • EP 3.2.9

  • ISO 8871-5

• Tested for:

  • Extractables & leachables

  • Endotoxins and particulate matter

  • Penetrability and fragmentation

  • Moisture vapor transmission and re-sealability

• Free from: Latex, phthalates, heavy metals, and PVC

Advantages:

• Saves time and cost in sterilization and preparation

• Minimizes contamination risk in aseptic manufacturing

• Ensures compliance with global pharmaceutical standards

• Excellent compatibility with 20 mm flip-off or aluminum seals