Sterile Ampoule Filling Machine

The machine is available in four models with varying outputs:

• AFS-1 (Single Head): Up to 25 ampoules/min (1,500/hour)
• AFS-2 (Two Heads): Up to 50 ampoules/min (3,000/hour)
• AFS-4 (Four Heads): Up to 100 ampoules/min (6,000/hour)
• AFS-8 (Eight Heads): Up to 200 ampoules/min (12,000/hour)

It supports ampoule sizes from 1 ml to 30 ml (model dependent) with a filling accuracy of ±1% using volumetric piston pumps. Nitrogen flushing is provided before, during, and after filling for enhanced sterility.

Key sterility and performance features include:

• Nitrogen gas flushing with ampoule neck centering to prevent oxidation
• “No Ampoule – No Filling” and “No Ampoule – No Seal” safety systems
• Pre-warming station for perfect, uniform flame sealing (LPG + Oxygen)
• All product contact parts made of SS 316L and non-contact parts of SS 304
• Flow meters for precise flame regulation and variable speed control
• Compact cGMP design with easy accessibility for cleaning and maintenance

These features ensure high sterility, low wastage, and compliance with international regulatory standards.

Washed and sterilized ampoules are loaded into the infeed hopper. They are automatically transferred via a starwheel to a moving rack in an inclined (slant) position. As the ampoules move forward, the machine sequentially performs:

1. Pre-gassing with nitrogen
2. Precise volumetric liquid filling
3. Post-gassing with nitrogen
4. Neck pre-heating
5. High-speed rotation and flame sealing

Filled and sealed ampoules are collected upright in a delivery tray. The slant design minimizes glass breakage and contamination risks while maintaining a sterile environment throughout the process.

This machine is widely used in the pharmaceutical, biotechnology, veterinary, cosmetic, and chemical industries for sterile injectable production.

Main benefits include:

• Superior sterility assurance through nitrogen flushing and immediate sealing
• High production output (up to 12,000 ampoules/hour) with consistent ±1% accuracy
• Minimal product wastage and reduced human intervention
• Quick changeover with minimum parts for different ampoule sizes
• Easy cleaning, low maintenance, and compact footprint suitable for cleanrooms
• Full cGMP compliance with robust SS 316L construction

It is perfect for both medium and large-scale sterile manufacturing while ensuring product integrity and regulatory compliance.

Yes — Adinath International Sterile Ampoule Filling Machine complies to cGMP, MHRA, FDA and WHO-GMP standards, with optional CE marked equipments and 21 CFR Part 11 software compliance for the HMI/PLC. Machine contact parts having Stainless Steel 316L grade materials with validation documents having IQ, OQ, DQ validation protocols as optional. Organization is ISO 9001:2015 certified.

Manufacturing lead time is generally 7 to 14 weeks from order confirmation. Further it takes 2 to 8 weeks for international shipping depending upon destination. Order can be expediate sooner or later as per specific buying requirements. Destination specific certifications like US FDA, EU, ANVISA, SFDA. CE can add 3 to 6 weeks additionally.

Yes, Adinath International Sterile Ampoule Filling Machine export this machine to more than 48 countries of this world including America, Europe, Asia, Middle East, Africa, CIS and Australia sub continents. Please visit our clientele page for complete list of our customers worldwide. Located at Ahmedabad, India having world class infrastructure.

Service of skilled engineers and technicians provided for technical support of supplied equipments. Installations, commissioning, training and IQ, OQ, DQ validations performed by qualified engineers. Remote support through video call, phone, email and other modes provided for international installations. Spare parts of Sterile Ampoule Filling Machine stocked at our premises in Ahmedabad and shipped immediately after ordering. Standard 12 months manufacturing warranty included with supplied equipment.