Lyostat5 - Biopharma · Every freeze-drying formulation has a critical temperature, below which it...
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Every freeze-drying formulation has a critical temperature, below which it should be maintained during primary drying in order to prevent processing defects. The Lyostat freeze drying microscope allows observation of the sample structure during drying and heating so that the exact point of collapse can be determined. Innovative lighting and image capture systems (with articulated head for easy sample loading) provide sharp visualisation for easy, accurate identification of structural changes. Once analysis has been carried out formulations and cycles can be developed that are safe, robust, and cost efficient. Every 1°C higher a formulation can be freeze dried at, results in an efficiency saving of 13%*. *Comparative Study by SP Scientific, Warminster, PA Lyostat5 Freeze Drying Microscope Biopharma Technology [email protected] | +44 (0)1962 841092 www.intelligentfreezedrying.com
Transcript of Lyostat5 - Biopharma · Every freeze-drying formulation has a critical temperature, below which it...
Every freeze-drying formulation has a critical temperature, below which it should be
maintained during primary drying in order to prevent processing defects. The Lyostat
freeze drying microscope allows observation of the sample structure during drying and
heating so that the exact point of collapse can be determined. Innovative lighting and
image capture systems (with articulated head for easy sample loading) provide sharp
visualisation for easy, accurate identification of structural changes.
Once analysis has been carried out formulations and cycles can be developed that
are safe, robust, and cost efficient. Every 1°C higher a formulation can be freeze dried
at, results in an efficiency saving of 13%*.
*Comparative Study by SP Scientific, Warminster, PA
Lyostat5 Freeze Drying Microscope
Biopharma Technology [email protected] | +44 (0)1962 841092
www.intelligentfreezedrying.com
Product Highlights
Real-time image, sample temperature and chamber pressure displayed on screen
Data archiving and profile plotting capability
Uses just 1to 2µl sample
LED light source for 60,000 hours of illumination
“Image Gallery” enabling comparisons of stored image sequences
High resolution camera provides sharp, clear visualization
Motorized vacuum control option, to enable specification of exact pressure
Pre-delivery testing includes validation of complete working system against a
published series of standard solutions
On-site installation includes practical training on operation and interpretation of results
IQ / OQ, service, maintenance and requalification packages
Case Study: Using Lyostat to improve
a freeze drying cycle
Background
A product was being freeze-dried using a generic cycle which was also applied to a number of other products. It was failing to meet the required moisture threshold (no more than 5%) and each batch was therefore rejected.
Lyostat analysis was carried out on a sample to establish the critical temperatures and an empirical review of the existing cycle was carried out.
Results
FDM analysis revealed “collapse zone” behavior, where the structure of the dried material is gradually lost over a temperature range. The collapse (Tc) onset was –26.1°C.
With Tc established, it was observed from the cycle trace that during primary drying the product was reaching a temperature that was very close to Tc. It was likely that the product was beginning to lose structure, resulting in the high moisture content.
Recommendations
The temperature used in primary drying was reduced to 5°C below Tc. This immediately led to a reduced moisture content and thus no more batch failures.
Lyostat5 Freeze Drying Microscope
Biopharma Technology [email protected] | +44 (0)1962 841092
www.intelligentfreezedrying.com
