Sterile Product Development by Parag Kolhe Mrinal Shah & Nitin Rathore

Sterile Product Development by Parag Kolhe Mrinal Shah & Nitin Rathore

Author:Parag Kolhe, Mrinal Shah & Nitin Rathore
Language: eng
Format: epub
Publisher: Springer New York, New York, NY


Qualification test

Test parameters

Shelf cooling

Maximum

Controlled

Shelf heating

Maximum

Controlled

Shelf control

Low temp

Intermediate

High

Condenser refrigeration

Maximum cooling rate

Ultimate low temperature

Vacuum system

Maximum evacuation rate

Ultimate low pressure

Leak rate

Threshold capabilities

Pressure control

Low

Intermediate

High

Condenser capacity

Threshold capabilities

Sublimation / Condensation Rate

Maintain CPPs

Maximum rates at predefined conditions



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