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 to provide our clients with the flexibility to develop a robust filling process on our engineering fill line and then to seamlessly transfer the product to our large scale filler for cGMP manufacturing for cGMP clinical or commercial finish drug product. The approach provides our clients with economical, attentive, flexible service to clients in pre-clinical to commercial scale development. Each of our fill lines use the same platform to transition knowledge discerned from engineering to solid cGMP processing of your valuable product.
For oxygen-sensitive products we can provide inert gas back filling of syringe headspace. Oxygen and shear sensitive products, such as proteins, are best suited for our patented BUBBLE-FREE FILLING® and stoppering method.
Filling specifications include:
About BUBBLE-FREE FILLING®
Our BUBBLE-FREE FILLING® technology offers an advantage to oxygen sensitive compounds. Online vacuum filling and stoppering technology minimizes operator interaction with the filled syringes relative to the older generation of off-line vacuum stoppering systems.