Prefilled syringe production requires regular batch testing to ensure consistency of the product within each syringe. Astech have developed an automated solution to carry out unattended high throughput batch testing of prefilled syringes. The system incorporates automation modules for preparation, testing and analysis depending on the product being tested, and the methods to be incorporated.
Examples of the type of equipment included within the system are as follows:
- Device Loading Tray Area
- Syringe Carousel
- Syringe Sheath Removal Station
- Syringe Deposit Station
- Solvent Dispense Station
- Liquid Handling System (includes HPLC injection valve)
- Automated needle/tip wash
- HPLC interface
The system is fully enclosed with the option of including environmental control or extraction.
The system is controlled by a modular software solution based around Astech’s proven architecture. This software solution is designed to run test methods specific to your requirements, and can include compliance to 21 CFR Part 11 if required. The main components of the software system are as follows:
- Control Server
- Graphical User Interface (GUI)
- Database Schema
Operators simply load the system with a batch of prefilled syringes from the production line and select the required test protocol for each syringe via the GUI. The system automatically performs testing and report analysis results back to the database.
Mixing Tube Flow – Basic flow only – does not include multiple additions or diluations.