CONTRACT
FREEZE DRYING
Outsourcing your product
begins with determining the suitability of it's present form
to the lyophilization (freeze drying) process. American Lyophilizer,
Inc has the resources to take you through the entire program:
Pilot
Testing and Lyophilization
Moisture Analysis
Preparing an 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.
QA Audit
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, Inc offers low
cost experimental runs (limited
to 2 kg 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
