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Multiple aspectsEssential TopicsD & F0 CalculationsA long list of topicsNarlin B. Beaty, Ph.D.
Be Sanitary
Outsource Your Aseptic Fill and Finish
Building sterile fill is an insignificant part of the manufacturing process. Unless you have multiple products that fit together into a filling facility and you are planning blockbuster sales for the overall mix, it probably doesn't make sense to build sterile fill. An argument that is usually put forth is that by building it ourselves, we can control the production and assure a supply. Running a sterile plant, and especially an aseptic fill unit is much harder than manufacturing active ingredient, non-sterile under cGMP. The regulatory bar is significantly raised and FDA scrutiny is intense.

Sublimation Science does not do Sterile Fill, but we can help you get it done. We can make phone calls and visit sterile fill facilities as may be needed, on your behalf. Dr. Beaty worked from 1983 through 2004 in the contract sterile fill business at Chesapeake Biological Laboratories in Baltimore, MD and knows the sterile fill business.
 
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© 2005 Narlin Bennet Beaty, Ph.D.