Pre-filled Syringe Testing
Pre-filled syringe testing is a vital part when developing and bringing safe injectables to market. These days more drugs are being placed in pre-filled syringes because they are efficient, easy to use and provide a more reliable and safer solution for patients as they contain the exact dose.
To meet sterile drug products’ regulatory, quality, and safety expectations different Container Closure Integrity Test methods can be used. FDA is encouraging sterile drug manufacturers to use validated and deterministic methods to confirm CCI during development, qualification and stability testing.
- The Sepha Multi-Q offers a vacuum decay test down to 5µm to perform a non-destructive liquid leakage test for pre-filled syringes. The system utilizes ASTM F2338-09 standard test method to perform the test and provides deterministic results in line with USP 1207 guidelines.
- The Sepha Multi-Q HD offers extra sensitivity and can identify leaks as small as 1µm.