Combining Nucleation Technology and Aseptic Processing

Combining Nucleation Technology and Aseptic Processing

Release Date: April 13, 2012

SP Scientific has announced a new LyoLearn webinar entitled "Combining Nucleation Technology and Aseptic Processing: The Impact on the Viability and Performance of Process Simulation Media Fills".

Presented by Dr. Karen A. Bossert from Lyophilization Technology Inc. - the 24th April 2012 webinar examines the impact of ControLyo™ Nucleation On-Demand technology on the viability of organisms potentially present in a lyophilizer. As well, the methodology and considerations for assessment of aseptic processing while utilizing the technology are discussed.

Lyophilized drug products are sterile solid dosage forms manufactured aseptically through a series of unit operations.  During lyophilization, to improve batch uniformity and ensure reproducibility batch to batch, recent advances in control of nucleation during freezing have been developed.  One new technology, ControLyo™ Nucleation On-Demand, pressurizes and depressurizes the freeze-dryer product chamber to induce controlled (simultaneous) nucleation during freezing for materials contained within the product chamber. To accurately assess the use of the technology during aseptic processing, the ControLyo™ technology must be incorporated into the processing of media-filled containers within the lyophilizer during a media fill.  However, this requires an understanding of the viability of various types of organisms in the environment during pressurization/depressurization, as well as development of a method for conducting the media fill which depicts an accurate use of the technology, while not interfering with the possible outcome of the media test.

 

This webinar is designed to provide participants with an understanding of this new technology for controlling nucleation of ice during manufacture of lyophilized drug products.  Further it will demonstrate the role of the new technology in the design of media fills and also illustrate the impact of ControLyo™ on the viability of microorganisms typically found in an aseptic manufacturing environment.

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Control Nucleation - On Demand

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