Pre-Filled Syringe Design Validation Testing
MET article published in ONDrug Delivery JOURNAL.
MET’s guide to providing comprehensive laboratory support for demonstrating the safety and efficacy of drug delivery systems can be found in the October 2107 edition of ONDrug Delivery- Prefilled Syringes and Injection Devices. The paper follows the theme of the magazine, using pre-filled syringes (PFSs) as an example. The principals involved of course apply to a wide variety to combination devices.
MET’s laboratory testing services are here to support your design validation / verification by applying appropriate standard tests and risk analysis driven studies. We will work with you to develop protocols which ensure that your specific products are comprehensively supported by robust information.
Our testing capabilities encompass most devices, implants, mucose membrane slow release devices, pumps, sprays, transdermal devices, inhalers and more.
The article details the process and many of the tests required for pre-filled injectors. These include data and literature review, risk analysis, sample size development and planning along with the need for validated studies using qualified equipment and technicians. This can be followed by examination of chemical extractables and leachables, actuation forces, strength, fatigue, stability, integrity, dose accuracy at different conditions (atmospheric pressure, temperature, humidity) and much more.