Prefilled Syringe Content Uniformity Testing
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 Syringe Pro® 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:
A growing number of drugs and vaccines are available in prefilled syringes. The manufacture and supply of prefilled syringe products is highly regulated to minimise chemical and physical changes and maintain drug efficacy.
Compared to oral administration, parenteral drug delivery provides rapid drug absorbed and avoids first-pass metabolism, or enzymatic degradation. This leads to better bioavailability, and more predictable pharmaco-dynamic and pharmacokinetic profiles. Compared to traditional parenteral delivery, prefilled syringes are easy to use, eliminate dosing errors and are not wastefully overfilled.
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.
Read more about the SyringPro specification
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 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.