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.