Controlling Nucleation on Production Freeze Dryers

ControLyo??? Nucleation On-Demand Technology Now Can Be Retrofitted

Production Freeze Dryer
Production Freeze Dryer

Stone Ridge NY, USA — SP Scientific has announced that ControLyo??? Nucleation On-Demand Technology can now be retrofitted to a wide range of previously installed production freeze dryers.

The ControLyo??? technology, patented by Praxair Inc., was licensed exclusively by SP Scientific in 2010 for use on development freeze dryers with shelf surface areas < 1.0 m2.

The technology was incorporated into the SP Scientific Lyostar 3 freeze dryer, the first commercial dryer to offer controlled nucleation capability.

Since that time, considerable research has been done at the development scale with controlled nucleation.

ControLyo??? technology offers many benefits to freeze drying in the biotech and pharmaceutical industries including improved vial-to-vial uniformity, reduced cycle times, easier process scale-up, reduced protein aggregation.

It also enables better conformance to the Food & Drug Administration’s Process Analytical technology (PAT), and Quality by Design (QBD) Initiatives.

In order for the benefits demonstrated in development work to offer economic benefits to companies, the technology has to be scalable to production freeze dryers.

SP Scientific and Praxair have demonstrated that many commercial production dryers can be relatively quickly and easily retrofitted to benefit from the advantages offered by ControLyo??? technology.

It has also been demonstrated on production freeze dryers as large as 300 ft2. (27 m2), that controlled nucleation was achieved in nearly 9000 vials, ranging in size from 20 ml to 100 ml with fill volumes of ?? and ??.

Economical retrofits and scalability of the technology open opportunities to significantly improve production cycles of lyophilized products, with concomitant reduction in costs.

For further information, and to check that your existing production freeze dryer can be retrofitted, please contact SP Scientific on +1-845-255-5000 (+44-1473-240000 in Europe) or email shireen.scott@spscientific.com.

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.

Worldwide Headquarters

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

Tel: +1.845.255.5000
Email: shireen.scott@SPscientific.com
Website: www.spscientific.com

Europe / Asia

Genevac Ltd.
Farthing Road
Ipswich IP1 5AP
UK

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