Intelligent Vial Washing, Sterilizing, and Liquid Filling Line (2ml - 30ml)

Intelligent Vial Washing, Sterilizing, and Liquid Filling Line (2ml - 30ml)

Engineered for the continuous, high-speed production of liquid medicines, including insulin and other critical sterile injectables, this advanced integrated production line consolidates ultrasonic vial washing, hot air sterilization, liquid filling, and stoppering into a single, seamless operation. The system leverages sophisticated electronic control technology to automate the entire production cycle, ensuring stringent quality control and high volumetric throughput for vials ranging from 2ml to 30ml.

Core Processing Modules

This comprehensive line consists of three synchronized processing stations to ensure complete product integrity from raw vial to sealed dosage:

• Ultrasonic Vial Washing Station: Utilizes high-frequency ultrasonic cavitation combined with purified water and compressed air to effectively remove particulates, ensuring vials meet strict clarity standards (>99%) before entering the sterilization phase.

• HACO Hot Air Circulation Oven (Depyrogenation): Following the washing cycle, vials are seamlessly transferred into the HACO oven. This module utilizes an advanced hot air circulation system to guarantee uniform heat distribution for complete drying, sterilization, and effective heat source (endotoxin/pyrogen) removal.

• XKFG Series Filling & Stoppering Machine: Designed specifically for high-precision dosing of insulin. This unit manages the liquid filling, post-fill air/nitrogen flushing, and automatic rubber stoppering, maintaining a strict filling tolerance of 1.5% and a stoppering success rate exceeding 99%.

Advanced Control & Automation Architecture

The entire production line is governed by a centralized, intelligent electronic control system designed to optimize line efficiency and minimize manual intervention:

• Real-Time Monitoring & Precision Control: Integrated sensor networks and actuators continuously monitor filling speeds, volumetric accuracy, and sealing pressure, allowing the system to self-adjust and maintain consistent product quality.

• SCADA / MES Integration: The control architecture is fully compatible with higher-level facility management systems (such as SCADA or MES), streamlining production workflows and inventory management.

• Process Data Analytics: The system automatically captures and analyzes critical production data, enabling operators to identify operational bottlenecks, optimize line speed, and reduce material waste.

Technical Specifications

Standard Line Performance Metrics

Regulatory Compliance & Validation Support

Our equipment is engineered to meet strict international regulatory standards, ensuring seamless integration into your facility's quality management systems.

• Complete Validation Documentation (DQ/IQ/OQ/PQ): We provide comprehensive validation protocols to support your regulatory submissions, including Design, Installation, Operational, and Performance Qualifications, alongside complete material traceability certificates for all product-contact components.

• GMP-Compliant Sanitary Design: Built strictly to Good Manufacturing Practice (GMP) principles. The equipment features crevice-free stainless steel construction and is fully compatible with CIP/SIP (Clean-in-Place / Sterilize-in-Place) procedures to eliminate contamination risks.

• Data Integrity & Traceability: Designed to support FDA 21 CFR Part 11 requirements. Our intelligent PLC systems feature secure multi-level user access, automated electronic audit trails, and real-time batch data recording that can be easily exported or integrated into your SCADA/MES systems.