1. Project Background

The production of medical vial injections requires extremely strict standards for sterile environments, filling accuracy, process traceability and GMP compliance. Traditional discrete production equipment features poor process connection and frequent manual intervention, easily causing cross-contamination. Meanwhile, it lacks stability for high-speed mass production and cannot meet the large-volume export production demands of high-end pharmaceutical preparations.

This project cooperates with Latina Aenova Pharmaceutical Factory in Italy, a leading manufacturer specializing in the export of vaccines, biological preparations and high-end sterile injections. Its mainstream production covers 5ml, 10ml and 20ml standard vials. The factory’s products are widely exported to the EU and North America, with strict mandatory specifications for production line automation, sterile grade, high-speed stability and product traceability.

The original outdated production line relied heavily on manual operation, resulting in common defects such as bottle contamination, uneven filling, capping failure and coding errors during high-speed operation, which led to low yield rates. In addition, complicated model changeover restricted capacity expansion. The upgraded fully automatic linkage production line realizes unmanned continuous operation including bottle washing, sterilization, filling, stoppering, capping, labeling and coding, fully complying with EU GMP clean production standards and pharmaceutical export quality inspection requirements.

2. Custom Production Line Configuration (Core Sterile Linked Processes)

Customized for the customer’s high-speed production requirements, the full line meets both Chinese and EU GMP standards and is equipped with a closed Class 100 laminar flow protection system. It supports flexible production at 30–150 bottles per minute, integrating full linked processes of bottle washing and sterilization, precision filling, stoppering and capping, labeling and coding. With zero manual transfer and zero cross-contamination risks, the line supports mixed production of 5ml, 10ml and 20ml multi-specification vials, adapting to both small-batch laboratory trial production and large-scale industrial high-speed manufacturing.

2.1 Automatic Ultrasonic Vial Washing Machine

Adopts optimized two-water and one-air precision cleaning technology, matching a maximum production speed of 150 bottles per minute. It thoroughly removes dust, impurities and residual stains inside and outside vials. The fully enclosed dustproof structure effectively prevents secondary pollution and meets EU sterile washing standards. The machine supports rapid mold change for flexible switching of different vial specifications.

2.2 Hot Air Circulation Sterilization & Drying Machine

Continuously connected with the washing process, the equipment adapts to the full-line beat of 30–150 bottles per minute. It completes high-temperature sterilization and hot air circulation cooling to eliminate microorganisms completely and maintain a sterile empty bottle state. Equipped with a constant temperature control system, all operating parameters are automatically stored and fully traceable, satisfying compliance requirements for high-grade sterile pharmaceutical production.

2.3 High-Precision Sterile Filling, Stoppering & Capping Integrated Machine

As the core equipment of the whole line, it is equipped with a customized high-speed servo ceramic pump system. Even running at 30–150 bottles per minute, the filling error is stably controlled within ±0.05ml, solving the common problem of uneven dosage in high-speed filling. The machine supports non-contact sterile filling for medicinal liquids and biological preparations. An optional nitrogen replacement device prevents liquid oxidation and deterioration. Matched high-speed stoppering, capping and servo crimping mechanisms precisely synchronize with the full-line rhythm, eliminating liquid leakage, loose caps and broken edges during high-speed operation. The stable sealing performance meets the long-term storage requirements of exported pharmaceutical products.

2.4 Automatic Vertical Vial Labeling Machine

Optimized with a high-speed servo deviation correction system to adapt to 30–150 bottles per minute high-speed labeling. It supports fixed-point single labeling and full-wrap labeling for vials, delivering bubble-free, wrinkle-free and skew-free labeling results. Compatible with medical traceability labels and anti-counterfeiting export labels, the machine rapidly switches between 5ml to 20ml vial specifications and ensures uniform and standardized product appearance in line with EU pharmaceutical packaging standards.

2.5 Zero-Consumable Laser Coding Machine

Synchronized with the production line beat, the laser coder prints batch numbers, production dates, expiry dates and anti-counterfeiting traceability codes on bottles and labels efficiently at high speed. With zero consumables and no ink pollution, the permanent coding is wear-resistant and clear. It eliminates errors and blurring caused by manual coding, realizing independent single-bottle traceability and fully complying with EU pharmaceutical supervision and cross-border export traceability regulations.

3. Applicable Production Parameters & Specifications

Applicable vials: 5ml, 10ml, 20ml standard medical vials

Applicable materials: sterile injections, biological preparations, pharmaceutical liquids, sterile reagents

Production capacity: 30–150 bottles/min (1800–9000 bottles/hour), supporting stepless speed regulation and flexible speed switching

Model change efficiency: rapid specification switching, suitable for customer’s small-batch trial production and large-volume export production mode

Material configuration: The whole machine adopts high-quality stainless steel. The material contact parts are made of 316 stainless steel and pharmaceutical-grade materials, which are corrosion-resistant, easy to clean, dead-angle-free, and fully adaptable to long-term continuous operation and cyclic disinfection in clean workshops.

4. Standard Sterile Process Flow

Automatic bottle washing & output → High-temperature sterilization, drying & cooling → High-speed sterile filling & sealing (automatic stoppering & crimping) → Synchronous vertical labeling → Online laser traceability coding → Finished product output & stacking

The full line realizes synchronous linkage and stepless speed adjustment with minimal manual intervention, fully adapting to high-standard sterile high-speed export production.

5. Project Implementation

Our engineering team delivered a full turnkey project for the Italian Aenova pharmaceutical plant, covering customized equipment tuning, factory assembly, on-site installation, pipeline connection and full-line linkage commissioning. Targeting the customer’s 30–150 bottles/min high-speed sterile production demands, we optimized the running beat of washing, filling, sealing, labeling and coding units to eliminate jamming, filling deviation and labeling errors.

During implementation, we provided professional operational and maintenance training for on-site staff, together with long-term remote technical support. The whole project was completed on schedule without delays. All indicators including running speed, filling precision, sterile performance and yield fully meet EU GMP standards. After multi-batch trial production verification, the line achieved stable high-speed mass production, successfully supporting the factory’s formal export batch production.

6. Project Summary

The Italian Aenova pharmaceutical team highly recognized the stable performance and GMP compliance of the full-automatic vial production line. The customer affirmed its stable high-speed operation within 30–150 bottles/min, consistent filling accuracy, low failure rate and perfect batch traceability effect. The complete unmanned linkage process effectively reduced contamination risks and labor costs, greatly improving export production efficiency and finished product yield. They commented that the customized solution fully matches European high-end sterile pharmaceutical manufacturing standards.

Tailored for high-end European pharmaceutical export scenarios, this high-speed sterile vial filling line fully meets the core requirements of Aenova Italy for high-speed production, sterile compliance, precision manufacturing and full-process traceability. Integrating automatic bottle washing and sterilization, filling and sealing, labeling and coding processes, the solution solves the industry’s long-standing dilemma of balancing high-speed mass production and high-standard sterile quality control. It enables standardized, efficient and large-scale export production of pharmaceutical injections, serving as a high-quality turnkey solution for automatic upgrading of global sterile pharmaceutical production lines.