Syringe-Pro

In the area of prefilled syringe production there is a need to carry out routine quality control batch testing to ensure regulatory compliance and consistency of the product. ASTECH have developed a noval automated platform to carry out unattended high throughput batch testing for such prefilled syringes. The system incorporates flexible automation modules for sample preparation and analysis which can be configured to suit individual customer requirements. Examples of the type of equipment included within the system are as follows:

• Syringe/Tube handling arm
• Configurable storage area for new and used syringes, tubes, vials, etc.
• Safety sheath removal station
• Syringe carousel and dispense station with gravimetric feedback
• Solvent dispense station with gravimetric feedback
• Mixing station
• Analysis instrument injection valve
• Remote database server
• Sharps container for safe disposal of tested syringes

The system is fully enclosed and interlocked with an interface for local vapour 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, the required test protocol for each syringe is then selected via the GUI. Once the system is started it will carry out the predefined tests on each of the syringes and report analysis results back to the database.