Sterile liquid preparation system for pharmaceutical use
In pharmaceutical production, maintaining aseptic conditions during the preparation of infusion solutions, injectable products, and oral liquids is crucial. Traditional methods may not always provide the necessary control and efficiency, leading to possible contamination and quality issues.
Automates production, cleaning, and sterilization processes
The Sterile Preparation Dosage System from Austar is a state-of-the-art aseptic liquid preparation system tailored for various dosage forms, including infusion solutions, injectable products, eye drops, and oral liquids. Utilizing a 3D modular design, the system offers a compact and efficient layout. Key components, such as the tank, pump, heat exchanger, filter, valve, and pipe, are sourced from top-tier international and domestic brands to ensure high quality. The Siemens S7-1500 CPU series and TP1200 Comfort touch screen are used for PLC and HMI, optimizing the program design for stability and traceability in accordance with GAMP5 standards. The system supports automatic control of production, cleaning, and sterilization processes. Validation involves comprehensive activities and tests like risk assessment (RA), design qualification (DQ), installation qualification (IQ), and operation qualification (OQ) to ensure stable, high-quality production under various conditions.
Benefits
- Ensures aseptic conditions for high-quality liquid preparations
- Utilizes reliable components from leading brands
- Optimized program design for stable and traceable performance
- Fully automated control of production, cleaning, and sterilization
- Comprehensive validation for consistent product quality