FTS LYOSTAR 3, Руководство оператора

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FTS Systems LyoStar™ 3 Praxair’s ControLyo™ Nucleation On-Demand
Technology
Rev 006, 01/14 53
© SP Scientific 2014
The ControLyo™ technology has been designed for SP Scientific’s LyoStar™ 3
lyophilizers to provide robust nucleation control capabilities. It is anticipated that the
ControLyo™ technology should be able to achieve the following in a LyoStar™ 3
lyophilizer:
Nucleate any lyophilization container greater than or equal to 2 mL in nominal
•
volume having a fill volume less than or equal to 75% of the nominal container
volume using argon gas at a temperature within 3
°
C of the formulation’s
thermodynamic freezing point.
Nucleate any lyophilization container greater than or equal to 5 mL in nominal
•
volume having a fill volume less than or equal to 75% of the nominal container
volume using nitrogen gas at a temperature within 3
°
C of the formulation’s
thermodynamic freezing point.
It is necessary to confirm experimentally the nucleation control capabilities for a given
combination of freeze-dryer and ControLyo™ system. As such, it will be necessary to
confirm experimentally the expectations provided above for the implementation of the
ControLyo™ technology.