Ampoule Filling and Sealing Machine Suitable for 1-10ml Glass Ampoules with Nitrogen-Purging Capability

Ampoule Filling and Sealing Machine Suitable for 1-10ml Glass Ampoules with Nitrogen-Purging Capability

The ampoule filling and sealing machine is designed for 1-10ml glass ampoules and supports nitrogen-purging during the filling process. Its main features include:

1. Pharmaceutical-Grade Sterility Assurance
   • Class 100 cleanroom standards: Triple air filtration system with microbial load control achieving SAL≤10⁻⁶ (viral inactivation level).
   • Comprehensive contamination control: Ultrasonic deep cleaning + 300℃ dry heat sterilization + nitrogen protection capping, compliant with EMA/FDA sterility requirements.
   • International Value: Directly suitable for production standards of regenerative medicine products in Europe and the USA.
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2. High-Precision Filling with Flexible Production
   • ±0.5% dosing error control: Servo-driven piston pump with real-time dosage adjustment via touchscreen, ensuring consistency for high-value products like collagen/peptide solutions.
   • Modular quick-change capabilities: Universal production line for 1-10ml ampoules, enabling 30-minute switches for varying formulations like hyaluronic acid gels/freeze-dried collagen powders.
   • International Value: Meets the custom demand of small batch production in the aesthetic medical industry (e.g., regional formulation adjustments).
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3. Global Compliance Certification Coverage
   • Triple certification backing: Compliant with GMP, ISO 13485, and FDA 21 CFR Part 11, supporting electronic batch records (aligned with European audit trail requirements).
   • EMA virus inactivation verification: Documentation supporting SAL≤10⁻⁶ validation reports accelerates the overseas registration of biological products.
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1. Intelligent and Traceability System
   • End-to-end traceability system: PLC-controlled QR code tracking from raw materials to packaging, ensuring full traceability.
   • Remote operational support: Multi-language interface (English/German/Spanish) and IoT fault diagnostics, reducing downtime risks for international clients.
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2. Lifecycle Cost Advantages
   • Energy-efficient design: Nitrogen consumption reduced by 40% compared to traditional nitrogen equipment; dry heat sterilization energy usage optimized by 30%.