Aseptic Fill & Finish
Aseptic Syringe Filling
AMRI has expertise in filling products into sterile and ready to use syringes. Prefilled syringes are the most preferred method for unit dose medication and the fastest-growing choice for many pharmaceutical organizations.
AMRI operates two syringe fill lines and provides attentive, flexible service to clients in pre-clinical to commercial scale development. In determining which fill line and most appropriate method, we consider project variables such as product characteristics, lot size and fill volume.
Traditional syringe filling and stoppering methods are applicable, yet not exclusive, to products requiring reconstitution at time of administering and a gas overlay.
Oxygen and sheer sensitive products such as proteins are best suited for our patented BUBBLE-FREE FILLING® and stoppering method.
Filling specifications include:
- Two fill lines
- Inova SV-122 syringe filler:
0.5ml to 20ml syringes at 50,000 units/day (or batch) - Inova H3-5V syringe filler:
0.5ml to 5ml syringes at 100,000 units/day (or batch) - Traditional filling
- BUBBLE-FREE Filling®
- Stoppering Options
About BUBBLE-FREE FILLING®
Our BUBBLE-FREE FILLING® technology may offer an advantage to oxygen sensitive compounds such as proteins, epinephrine and others where dissolved oxygen negatively impacts solution stability. In addition to benefits in product stability, BUBBLE-FREE FILLING® creates an unfavorable environment for the growth of micro-organisms and may add additional assurance of sterility in the event of an accidental low level contamination. Online vacuum filling and stoppering technology minimizes operator interaction with the filled syringes relative to the older generation of off-line vacuum stoppering systems.
