Multi-Function Ampoule Filling Machine for Diverse Applications 16000BPH-40000BPH Output Capacity

This versatile multi-function ampoule filling machine isdesigned to meet the diverse needs of pharmaceutical and biochemical industries. Key features include:

1. Comprehensive Sterilization and Compliance

• Maintains a sterile environment adhering to Class 100 cleanroom standards with an effective three-stage air filtration system.
• Ensures thorough cleaning and sanitization through a combination of ultrasonic cleaning and 300℃ dry heat sterilization, meeting the guidelines set by EMA and FDA for injectable products.

2. High-Speed and Precise Filling

• Capable of filling at speeds ranging from 16,000 to 34,000 bottles per hour, depending on the product volume, with a tight filling accuracy of ±0.5%.
• Easily adaptable for filling various formulations, including injectable drugs, vaccines, serums, and high-purity chemical solutions.

3. Regulatory and International Standards Compliance

• Proudly certified with GMP, ISO 13485, and FDA compliance, providing assurance for quality and safety throughout production.
• Supports electronic batch records, facilitating easier compliance with audit requirements.

4. Innovative Traceability Features

• Integrates a comprehensive tracking system utilizing PLC technology and QR codes, ensuring full traceability of raw materials throughout the entire production process.
• Offers remote maintenance and diagnostics capabilities to enhance operational reliability and minimize downtime.

1. 1. 5. Sustainability and Cost Optimization
      • Smart design promotes energy efficiency, reducing nitrogen consumption by up to 40% compared to traditional systems and optimizing sterilization energy consumption by 30%.