Stoppering Machine

This advanced capping system is engineered to meet the rigorous demands of pharmaceutical and biotech industries by ensuring high precision, sterility assurance, and full traceability. It achieves a 99.99% pass rate, with rubber stopper placement accuracy ≤±0.1 mm, eliminating issues like misalignment, tilting, or floating stoppers. The precise controllable capping pressure (50–500 N) ensures tight seals with a pressure deviation ≤±5 N, resulting in a seal leakage rate ≤0.01%.

The system maintains bottle residual oxygen ≤1% when paired with nitrogen headspace replacement, effectively blocking oxygen and microbial ingress, thereby extending the shelf life of liquid formulations from 2 to 5 years. Post-capping, the rubber stoppers exhibit excellent flatness (deviation ≤±0.2 mm) without deformation or damage, providing a stable foundation for subsequent crimping or screw capping processes.

Capable of handling various types of stoppers including butyl rubber, silicone-coated, and halogenated butyl, it supports different sizes (Φ13-Φ32mm) and ensures compatibility across multiple bottle designs such as crimp neck, threaded, and vial bottles, meeting USP/EP/ChP leak test standards. The capping process is fully enclosed, minimizing the risk of stopper detachment or contamination through vacuum-assisted stopper pickup and mechanical positioning, achieving a stopper delivery breakage rate ≤0.05%.

Sterility is guaranteed with SIP capability at 121°C, reaching an SAL of 10⁻⁶, suitable for aseptic liquid formulations. The system includes tamper-proof electronic batch records (EBR), IQ/OQ/PQ validation packages, and H14 HEPA filters maintaining Class A cleanliness levels. All parts in contact with materials are made from 316L stainless steel and PTFE, certified to USP Class VI, ensuring zero leachables and minimal adsorption.

Designed for flexibility, the system can integrate modules for stopper sterilization, drying, and capping, reducing material transfer steps and boosting efficiency. Quick changeover times (≤15 minutes) allow for rapid switching between container and stopper specifications. Operated via PLC + touchscreen controls, it offers 100+ programmable capping recipes, real-time monitoring, and self-diagnosis features, enabling remote management and quick fault resolution.

Energy-saving technologies and international components ensure low maintenance costs and long service life, making it ideal for global liquid formulation production lines.