What is an Ampoule Bottle Linkage Production Line? Applications and Value in Aseptic Production for Pharmaceutical Companies

An ampoule bottle linkage production line is a core system in pharmaceutical aseptic liquid manufacturing. It integrates washing, sterilization, drying, filling, and sealing into a continuous process, significantly improving production efficiency and medicine safety.

An ampoule bottle linkage production line is a highly automated system designed for the production of 1–20ml ampoulesused in water injections, injections, and biopharmaceuticals. Compared with traditional separate operations, it provides the following advantages and value:

1. Integrated Workflow: Combines washing, sterilization, drying, filling, and sealing in one line, reducing manual handling and cross-contamination.

2. Efficient Washing & Sterilization: Uses ultrasonic cleaning, multi-stage water-air rinsing, and hot-air tunnel sterilization to achieve ≥99% clarity and reliable aseptic control.

3. Accurate Filling: Ceramic piston pumps or servo-driven filling systems ensure consistent dosage with ±0.5–2% accuracy.

4. Reliable Sealing: Automatic flame-sealing with bottle rotation delivers neat, strong seals while minimizing breakage rates (≤0.1%).

5. Smart Compliance: Equipped with online monitoring, automatic rejection, and data traceability to comply with updated GMP and international quality standards.

Applications: Widely used in pharmaceutical factories for aseptic production of injections, water injections, vaccines, and antibody-based biopharmaceuticals. It enables companies to achieve mass production, regulatory compliance, and labor cost reduction simultaneously.

Q1: Can the ampoule bottle linkage production line quickly switch between different ampoule sizes?
A1: Yes. The machine supports 1–20ml ampoule sizes, with modular changeover design for fast and easy switching, ideal for multi-size flexible production.

Q2: How is filling accuracy guaranteed?
A2: The line uses high-precision ceramic piston pumps or servo-driven systems, combined with online monitoring and automatic compensation, keeping dosage errors within ±0.5–2%, fully compliant with GMP standards.

Q3: Is the equipment easy to maintain?
A3: With modular construction, key parts are easy to disassemble and replace. Automatic lubrication and self-diagnostic features simplify daily maintenance and reduce downtime.

Q4: What compliance standards does the line meet?
A4: It fully complies with GMP, CE, and ISO standards, with data traceability and batch record functions to meet pharmaceutical companies’ quality and regulatory requirements.