A rubber stopper is a pharmaceutical-grade sealing component designed to create an airtight, sterile barrier for vials containing injectable medications.
| Parameter | Typical range | Notes & selection driver |
|---|---|---|
| Diameter | 13-32 mm (standard vial sizes) | |
| Durometer | 40-50 Shore A | |
| Thickness | 2.5-4.0 mm | |
| Extractables | < 5 μg/mL per USP <1663> | |
| Sterilization | Gamma 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.
This component is used in the following industrial products
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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.
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.
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