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.
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).
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.

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.
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%.

Established in 2013, Suzhou Lingyao Intelligent Equipment Co., Ltd. has a strong reputation for providing innovative and reliable solutions to meet the diverse needs of companies. The company's product range includes a wide variety of equipment such as intelligent filling machines, labeling & packaging machines, also include medical blister packagings and injection madical devices.

With a team of experienced engineers and technicians, Suzhou Lingyao Intelligent Equipment Co., Ltd. provides customized solutions to meet the specific requirements of its customers. The company also offers excellent after-sales service and technical support to ensure customer satisfaction.

Overall, Suzhou Lingyao Intelligent Equipment Co., Ltd. is known for its commitment to quality, innovation, and customer service in the intelligent equipment industry.