Lyophilization Know-How for Process Cycle Development and Optimisation
From the beginning of the activities in the freeze drying 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 freeze drying process parameters, giving the chance to shorten the process or to increase the quality of the frozen 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.