Freeze drying is being increasingly used in both formulation development and manufacturing of pharmaceuticals for poorly solubles, biopharmaceutical molecules and, more recently, biosimilars.
Another trend is the growth in the number of siRNA and antibodybased formulations. These compounds regularly…
Read MoreFreeze drying is known to be a time consuming process with primary drying phases ranging from several hours up to weeks, depending on the product. During primary drying the product temperature at the ice sublimation interface (T p ) must…
Read MoreResearchers seek to develop a rapid parallel drying process that achieves high levels of sample dryness while drying every sample every time.
For many years, lyophilization, or freeze drying, has been used to dry samples in the laboratory. The technique…
Read MoreThis study develops the correlation of cycle parameters between a laboratory and a production freeze-dryer. Once the correlation has been established, it will be far easier to convert laboratory dryer cycle parameters to those for production. The study considers the…
Read MoreBy monitoring lyophilization chamber moisture content, the freeze drying process can be monitored in situ. Cold plasma ionization is a technique that depends on the ionization of nitrogen and water molecules using a radiofrequency generator and spectrometric signal connection. This…
Read MoreDirective 21CFR part 211.92 states that containers used for parenteral drugs, shall be
“clean”, “sterile” and “pyrogen free”. This can be accomplished by washing machines
and sterilization/depyrogenation equipment.
The crystal structure formed by ice in a frozen product directly impacts on the way in which the product will freeze-dry, and therefore influence drying time. But the process of nucleation, unless properly controlled, can be variable and even random…
Read MoreMay 2011
While there is no specific GMP requirement for CIP in freeze drying, both EU and FDA regulations recognise there is a need for cleaning of freeze dryers, especially if there is already an identified requirement for sterilization. In…
Read MoreMay 2011
Calibration of gauges used to measure pressure during freeze-drying processes fulfills two functions: quality assurance and equipment performance.
An interesting article by MKS Instruments in Pharmaceutical Technology magazine from 2002.
Read MoreMay 2011
A short but useful guide to the process from freeze drying & laboratory equipment specialists SP Scientific.
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