Aseptic Fill & Finish
AMRI offers a range of sterile lyophilization techniques that allows for pre-clinical to clinical scale lyophilization while utilizing commercial grade redundant components. We offer specialized expertise in developing and optimizing lyophilization processes.
The Lyophilization Unit at AMRI allows for programmable recipe automation for assured repeatability of multiple lots. The machine offers thirty six square feet of shelf area, allowing for the lyophilization of up to 12,000 vials per batch and three removable trays for the lyophilization of vials up to 250 mL.
Whether you have your own developed lyophilization cycle, or would like assistance in developing one, our engineering team will work with you to achieve your production goals in a cGMP-compliant environment.
Filling Specifications include:
- 6 product shelves
- 36 square feet of shelf area
- 2 shelf inter-distant settings
- Lead/Lag circulating pumps
- Redundant systems