Lyophilization know-how for process cycle development and optimisation
Application testing: From the beginning of the activities in the freeze
drying (lyophilization / lyophilisation) business, GEA Lyophil has run an test
center for own research and development and to provide technical support and
freeze drying know-how to the pharmaceutical industry.
GEA Lyophil has
the expertise to assist you in cycle development and in qualifying and
validating your technical systems. Our expertise and years of experience in
this technological area is your assurance of production reliability.
Different tests, often carried out in close cooperation with the
customer, are used to determine critical process parameters, giving the chance
to shorten the process or to increase the quality of the frozen product.
Why freeze dry?
Freeze dried products retain
their original properties. By adding water or other solvents they can be
reconstituted easily and very quickly to a usable solution. There is no need
for cooling during storage, therefore storage costs decrease and handling is
made easier.
Process expertise
Beside activities related to product
handling and contamination prevention (loading/unloading, cleaning and
sterilisation of the freeze dryer) the freeze drying process consists of three
main steps: freezing, main (primary) drying and secondary drying. Process
parameters determining these phases have to be carefully examined and
determined to achieve an optimum process cycle leading to an optical and
physical perfect pharmaceutical product.
Critical process parameters
Whether for your
existing or for new to develop products, GEA Lyophil is at your side to provide
freeze drying know-how and assistance to determine critical process parameters
and to help you to achieve an economical process cycle and a perfect quality
product.
- Electrical resistance and temperature
measurements:
Provides data to develop the optimum freeze drying
parameters for the process: freezing temperature, freezing speed, drying
pressure and shelf temperature in the main drying step.
- Cryomicroscope:
For documentation of freezing and
melting points .Documented by photos.
- TLC: Thermodynamic Lyophilization Control
- Freeze Drying Tests:
Test with customer product
or placebo to optimize the drying cycle, for example to shorten the process or
to increase the product quality of the freeze dried product.
- Residual moisture measurements
After the freeze drying
process, the product is unloaded and the residual moisture content is measured
by the thermogravimetric scales and the use of the Karl Fischer titrator.
For more information about our application support please us the contact box
to the right.