The Ampoule Linkage Production Line is a fully automatic integrated production system, specially designed for the continuous and sterile production of ampoule preparations. It integrates multiple processes into a seamless linkage, including ampoule feeding, cleaning, drying, sterilization, filling, nitrogen flushing, sealing, leak testing, labeling and coding. Complying with GMP, FDA and CE standards, it is widely applied in pharmaceutical and biopharmaceutical industries for the production of injections, vaccines, biological agents and other sterile products.
1. Core Structure & Working Principle
The line adopts a modular linkage design, with each functional unit (feeding module, cleaning module, sterilization module, filling-sealing module, inspection module, labeling module) connected seamlessly. Controlled by a PLC touch screen system, it realizes synchronous operation of all modules, ensuring continuous and efficient production without manual intervention. The core working principle is to complete the entire production process in a closed sterile environment, minimizing product contamination and ensuring product safety and consistency.
2. Key Functions
Automatic Feeding & Orientation: Stable feeding of empty ampules, automatic sorting with upward openings, adjustable speed to match production capacity.
Cleaning & Sterilization: Two-stage cleaning (high-pressure purified water flushing + air blow-drying), tunnel high-temperature sterilization (180-250℃) with HEPA filtration.
Precision Filling & Nitrogen Flushing: Precision piston/peristaltic pump filling, double nitrogen flushing (purity ≥99.999%) to prevent oxidation of active ingredients.
Sealing & Inspection: Infrared/flame sealing with quality detection; vacuum/pressure leak testing to reject unqualified products.
Labeling & Coding: Automatic labeling, laser/inkjet coding for production date, batch number and expiration date, realizing full traceability.
3. Core Advantages
Seamless Linkage: Modular design ensures smooth connection of all processes, improving production efficiency and reducing ampule breakage.
Strict Sterility: Closed sterile environment, HEPA filtration and pharmaceutical-grade contact materials, avoiding cross-contamination.
Full Automation: PLC control, no manual intervention, reducing human error and ensuring stable production.
Strong Versatility: Compatible with multiple ampule specs, customizable to meet different production needs.
Full Traceability: Real-time parameter recording and coding, meeting pharmaceutical regulatory requirements.
4. Application Scope
It is mainly used for the sterile production of ampoule preparations in pharmaceutical, biopharmaceutical industries, including injections, vaccines, biological agents, blood products, etc. It is the core equipment for enterprises to realize standardized, efficient and sterile production.
