Cap
Medical-grade halobutyl rubber vial stoppers compliant with global pharmacopeial standards, offering superior seal integrity, low particulate generation, and excellent compatibility with a wide range of injectable formulations and vial sizes.
Designed for high-integrity sterile packaging of injectable pharmaceuticals, our injection vial caps/stoppers deliver unmatched performance in safety, sealing reliability, chemical inertness, and regulatory compliance. The stopper core is manufactured from medical-grade butyl or halobutyl rubber—highly inert, non-leaching, and free from heavy metals or plasticizers—ensuring zero drug contamination. Fully compliant with USP Class VI, EP 3.1, ISO 10993, and GMP requirements, the product demonstrates excellent biocompatibility with no cytotoxicity or sensitization risk.
Featuring a dual-seal design (elastomeric stopper + protective overseal), it provides exceptional barrier protection against moisture and oxygen ingress, significantly extending drug shelf life. The stopper maintains seal integrity under extreme conditions—from -20°C deep freeze to 121°C autoclave sterilization—and withstands lyophilization cycles without deformation or leakage. Rigorous dimensional tolerances ensure perfect fit with standard 1 mL to 50 mL glass vials, while the optimized puncture geometry minimizes coring and particle shedding during needle insertion.
The aluminum or plastic overseal offers crush resistance, microbial protection, and optional features like easy-peel rings, color coding (e.g., blue, gray), and clear batch/expiry printing for traceability. Fully compatible with high-speed automated filling lines, the system supports both liquid and lyophilized injectables. Lightweight and durable, it reduces logistics costs and waste, with recyclable components aligning with sustainable packaging initiatives. Ideal for IV, IM, and SC drug delivery formats across biologics, vaccines, and small-molecule therapeutics.
| Category | Specifications / Features |
|---|---|
| Material | Medical-grade butyl / halobutyl rubber (stopper); Aluminum or plastic (overseal) |
| Compliance | USP <381>, USP Class VI, EP 3.1, ISO 10993, GMP compliant |
| Biological Safety | Non-cytotoxic, non-sensitizing; no heavy metals or plasticizer migration |
| Sterilization Methods | Compatible with steam (121°C), gamma irradiation, and ETO sterilization |
| Temperature Range | Stable from -20°C to +121°C |
| Sealing Performance | Dual-seal system; low moisture/oxygen permeability; leak-proof under inversion & vibration |
| Puncture Characteristics | Low coring, minimal particle generation; optimized puncture force |
| Vial Compatibility | Fits standard 1 mL – 50 mL glass vials with tight dimensional tolerance |
| Overseal Features | Crush-resistant; optional easy-tear ring; color-coded (blue, gray, etc.); printable surface |
| Automation Ready | Fully compatible with high-speed washing, filling, and capping lines |
| Special Applications | Suitable for lyophilized powders, liquid injectables, biologics, and vaccines |
| Sustainability & Cost | Recyclable (aluminum cap); lightweight design; low breakage rate; cost-effective at scale |







