SP SCIENTIFIC says that its ControLyo nucleation on-demand technology can now be retrofitted to a wide range of production freeze dryers.
ControLyo technology is now available to retrofit, even on larger production freeze-dry units
The technology was originally developed and patented by Praxair, and licensed by SP for use on development freeze dryers with shelf surface areas less than a square metre.
The technology was incorporated into the SP Scientific Lyostar 3 freeze dryer, the first commercial dryer to offer controlled nucleation capability.
Since then the companies have demonstrated that many commercial production dryers, some as large as 27m2, can be retrofitted to benefit from the advantages offered. In these larger units controlled nucleation was achieved in nearly 9000 vials, quarter- to half-full, from 20ml to 100ml in size.
SP Scientific and Praxair say that such retrofits are economical and present opportunities to improve production cycles and reduce costs of lyophilised products.
Further research into controlled nucleation has advanced the technology. ControLyo improves vial-to-vial uniformity, reduce cycle times, makes process scale-up easier, and reduces protein aggregation.
It also improves conformance to the US Food and Drug Administration’s Process Analytical technology (PAT), and Quality by Design (QBD) Initiatives, says SP.