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
- 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
- Vortexer
- HPLC interface
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.
