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Automatic Ampoule Filling Line: (Ampoule Compact Line)
Injectable Ampoule Filling Line ₹4,500,000.00
Injectable Ampoule Filling Line
Precision and sterility are the cornerstones of injectable manufacturing. Harsiddh Unimach provides high-performance, fully integrated Injectable Ampoule Filling Lines designed specifically for the rigorous demands of the global pharmaceutical and biotech industries. Our lines are engineered to handle the entire process—from washing and sterilization to high-speed filling and hermetic sealing—ensuring zero contamination and maximum output.
Our Integrated Line Components
A complete Harsiddh Unimach Ampoule Line typically consists of:
- Automatic Vertical/Rotary Ultrasonic Ampoule Washing Machine: Utilizing advanced ultrasonic waves and multiple water/air wash cycles for high-level de-pyrogenation.
- Sterilizing & Depyrogenating Tunnel: For continuous sterilization of washed ampoules using hot air laminar flow.
- Automatic Ampoule Filling & Sealing Machine: Available in 2, 4, 6, and 8-head configurations for high-speed volumetric filling and draw-off sealing.
- External Ampoule Washing Machine: To ensure the exterior of the sealed ampoule is free from any chemical or liquid residue.
Salient Features
- Total cGMP Compliance: The entire line is constructed with SS 316L contact parts and an SS 304 frame, featuring smooth, crevice-free surfaces for easy cleaning.
- Synchronized High-Speed Operation: Perfectly balanced speeds across the line, capable of processing up to 12,000 to 18,000 ampoules per hour.
- Precision Filling Technology: Servo-driven or piston-based filling pumps ensure ±1% accuracy, minimizing product loss of expensive injectables.
- In-Process Gas Flushing: Pre and post-filling nitrogen/carbon dioxide flushing to preserve the stability of oxygen-sensitive drugs.
- Advanced Safety Interlocks: Features “No Ampoule – No Fill” and “No Ampoule – No Gas” systems to prevent material waste and maintain safety.
- Centralized PLC Control: Comprehensive HMI interface allows for recipe management, real-time monitoring, and total control over line parameters.
- Laminar Air Flow (LAF) Integration: Optional LAF units can be integrated over the filling and sealing zone to maintain Class 100 sterility.
Frequently Asked Questions
Can the line handle different ampoule sizes?
Yes. Our lines are highly versatile and can be adjusted for ampoules ranging from 1ml to 25ml. Only a few "change parts" (like star wheels and guides) are needed to switch between sizes, which can be done with minimal downtime.
How is the sterility of the product guaranteed?
Sterility is maintained through the integration of a Sterilizing Tunnel (using HEPA filters and high heat) and the option to add Laminar Air Flow (LAF) units over the filling zone, ensuring the environment meets Class 100 standards.
What is the benefit of "Draw-off Sealing" used in your machines?
Draw-off sealing is the industry standard for injectables. It melts the glass and pulls the tip away, creating a smooth, rounded seal that is more secure and aesthetically superior to "tip-sealing," which can leave sharp edges or pinholes.
Is the filling volume adjustable for different liquids?
Absolutely. The volumetric filling pumps can be fine-tuned via the PLC or mechanical stroke adjustment to accommodate different liquid viscosities and ensure exact dosages for every batch.
