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Vials Aseptic Filling & Sealing System: Revolutionizing Sterile Injectable Production for Vaccines and Biologics

2016-07-13

GMP-Certified Solution for High-Speed Vial Processing in Pharmaceutical and Biotech Sectors

1. Precision Engineering for Critical Applications
The LYKGF Series integrates filling, stoppering, and capping into a single automated line, specifically designed for:

Vaccine production: Ensures ≤0.5% dosage deviation for mRNA/DNA-based formulations.
Biologic drugs: Maintains ISO 5 cleanroom standards during monoclonal antibody (mAb) and biosimilar filling.
Lyophilized injectables: Patented anti-vibration design prevents powder spillage during freeze-dried product handling.

2. Key Innovations Driving Industry Demand
✅ Zero-Contact Aseptic Transfer

Utilizes RABS (Restricted Access Barrier System) technology, reducing human intervention risks by 92% in cytotoxic drug production.

✅ Smart Changeover Capability

Accommodates 2-100ml vials with <15-minute mold adjustment, ideal for CDMOs handling multi-product campaigns.

✅ Data Integrity Compliance

Embedded ERP interface generates FDA 21 CFR Part 11-compliant electronic batch records, enabling full traceability for audits.

3. Global Market-Ready Features

Certifications: Compliant with EU GMP Annex 1, WHO-PQ, and PIC/S guidelines.
Material Compatibility: Validated for use with cyclic olefin copolymer (COC) vials and fluoropolymer-coated stoppers.

4. Real-World Impact
A Southeast Asian vaccine manufacturer achieved:

40% throughput increase (up to 24,000 vials/hour)
60% reduction in particulate contamination rates
100% compliance with EMA pre-approval inspections