SP Scientific: Combining Nucleation Technology and Aseptic Processing

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.

SP Scientific's program of free educational webinars delivered by industry experts are devoted to freeze-drying topics, and follow a 45-minute format for the presentations with a Q&A session immediately afterwards.  To register for the April 24th 2012 webinar please visit the SP Scientific website* or contact the company on +1-845-255-5000 (+44-1473-240000 in Europe).

SP Scientific is a leading manufacturer of laboratory to production scale freeze dryers / lyophilizers, centrifugal evaporators and concentrators, thermal control system and glassware washers. The company sells its products under well-known brands including FTS Systems, VirTis, Hull, Genevac, and National-Hotpack. SP Scientific has ISO 9001:2008 registered production facilities in the USA and Europe.

* Link for webinar registration:  http://www.spscientific.com/LyoTech-Center/LyoLearn-Webinars.aspx

Worldwide Headquarters

SP Scientific Inc.
3538 Main Street
Stone Ridge
NY 12484
USA

Tel: +1.845.255.5000

e: shireen.scott@SPscientific.com
www.spscientific.com

 

Europe / Asia

Genevac Ltd.
Farthing Road
Ipswich IP1 5AP
UK

tel. +44-1473-240000
email salesinfo@genevac.co.uk