Testing is an important step in the manufacturing process for prefilled syringes to ensure product quality and stability. Patient safety, drug stability, and ease of filling are being addressed with new designs and coatings and materials. Astech’s Syringe Pro system is designed to provide safe, high throughput, testing of prefilled syringe products for the highly regulated parenteral drug market.

The system is fully enclosed with the option of including environmental control or extraction. Syringe Pro® systems can be controlled by a modular software solution based around Astech’s proven architecture. This software solution is designed to run syringe test methods specific to your requirements, and can include compliance to 21 CFR Part 11 if required. 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. The main components of the software system are as follows: