Contract Freeze Drying
Outsourcing your product begins with determining the suitability of its present form to the lyophilization (freeze drying) process. American Lyophilizer has the resources to take you through the entire program including:
- Pilot Testing and Lyophilization
- Moisture Analysis
- Preparing Optimal Drying Protocol that can be transferred to Production Freeze Dryers in minimal time
- Determination of Suitable Packaging for non-vialed products
Providing a Proposal
A detailed discussion of your project goals is essential and is usually accompanied by conference calls or on site visits. We gladly welcome tours of our facility. With a thorough understanding of your needs and the specifics of your project, we can submit a detailed proposal and cost estimate.
As part of your due diligence, we fully expect that a formal QA audit may be necessary. We will work with your QA to provide a date for the audit and an agenda to maximize your audit time.
For non cGMP products, American Lyophilizer offers low cost experimental runs, (limited to 2kg or 5 liters) on a quick turnaround time (24 to 48 hrs), to provide the suitability of your product to the process.
For details on all services, call Bill Rariden at: (610) 999-4151
One fine body…