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:
- 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.
-
- 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).
-
- 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.
-
Specifications | |
Weight | 1500KG |
Dimensions | 5000mm L x 2000mm W x 1950mm H |
Total Power | 35KW |
Voltage/Frequency | 380V/50Hz |
Filling Method | Stainless Steel Pump or Peristaltic Pump (customizable) |


- 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.
-
- Lifecycle Cost Advantages
- Energy-efficient design: Nitrogen consumption reduced by 40% compared to traditional nitrogen equipment; dry heat sterilization energy usage optimized by 30%.