Product

1. Product Introduction

High-hermetic screw cap is the core sealing component of the vial packaging system. It usually consists of an overcap (plastic or metal), a pharmaceutical rubber stopper, and a tamper-evident structure. Its core design replaces the crimping process of traditional aluminum-plastic combination caps with threaded screwing connection, enabling repeated opening and resealing.

Unlike traditional aluminum caps that require destructive opening, the screw cap adopts a threaded structure: the inner side of the overcap is equipped with threads matching the vial neck, and the embedded rubber stopper forms an elastic abutment seal with the vial finish. This structure not only ensures high hermeticity during transportation and storage, but also enables convenient operation in clinical use—simply unscrew the cap for liquid extraction or compounding, and re-screw it after use to maintain sealing.

Specification Compatibility: Suitable for standard vial finishes 2R–100RSterilization: Autoclavable at 121 °C / 30 min

2. Core Advantages

2.1 High Hermeticity and Integrity Assurance

· Elastic Sealing: Elastic abutment between the rubber stopper and vial finish, combined with precise torque control, forms an airtight seal.

· High Barrier Property: Multi-layer structure with barrier layer design achieves efficient barrier against oxygen and water vapor.

· Anti-Blow-Out Ring Design: Optimized connecting ring structure avoids blow-out failure caused by internal pressure during high-temperature sterilization.

2.2 Operational Convenience and Safety

· Non-destructive Opening: No need to pry open aluminum caps violently; twist to open, eliminating scratch risks.

· Re-sealable: Can be re-screwed to maintain good sealing, unlike aluminum caps that are discarded once opened.

· One-Hand Operation: Thread structure with non-slip texture facilitates one-hand opening in clinical use.

· No Metal Particulate Contamination: No aluminum debris from aluminum cap crimping, avoiding contamination of production environment and drug solution.

2.3 Process Compatibility

· High-Temperature Sterilization Resistant: Withstands 121 °C / 30 min autoclaving without deformation or leakage.

· Precise Torque Control: Automatic capping equipment enables accurate torque control to ensure sealing consistency.

· Compatible with Existing Production Lines: Matches with standard vial filling and capping equipment.

2.4 Innovative Structural Design

· One-Piece Structure: Some high-end products adopt integrated injection molding, no assembly required, reducing cost and improving sealing performance.

· Anti-Displacement Design: Thread section closely fits the rubber stopper top to prevent stopper displacement from affecting sealing.

· Multiple Puncture/Opening Modes Available: Can integrate tear-off membrane, pull ring, puncture section and other opening structures.

3. Comparison with Traditional Aluminum-Plastic Combination Caps

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4. Typical Application Scenarios

· Biological Products: Monoclonal antibodies, vaccines and other products requiring high sealing integrity.

· Lyophilized Powder for Injection: Products requiring long-term low moisture and high vacuum storage environment.

· Clinical Compounding Drugs: Vial packaging requiring multiple withdrawals or fractional administration.

· Cell and Gene Therapy Drugs: High-value drugs with minimum contamination risk requirements.

· Veterinary Medicine: Convenient for drug preparation and repeated use, reducing operation difficulty.

5. Key Points of Quality Control

· Torque Control: Capping torque must be precisely controlled within the specified range; over-tightening may deform the stopper, and under-tightening affects sealing.

· Stopper Compatibility: Chemical compatibility between stopper material and drug solution must be verified to ensure low extractables and leachables.

· High-Temperature Validation: For terminal sterilization products, verify the sealing integrity of the capping system under high-temperature conditions.