TECHNOLOGY TRANSFER OF STERILE PROPDUCTS - IIR
TECHNOLOGY TRANSFER OF STERILE PROPDUCTS - IIR
TECHNOLOGY TRANSFER OF STERILE PROPDUCTS - IIR
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Technology Transfer for Lyo Product Manufacturing<br />
(Scale up Issues, Phase III and Commercial)<br />
Lyophilization (Equipment Related):<br />
IQ, OQ, PQ<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
Temperature & pressure tolerance < cycle parameter tolerance<br />
Evaluate surface mapping:<br />
‣ intra and inter shelf temperature range vs. lyo cycle shelf<br />
temperature set point, load vs. unload, fluid path in shelf<br />
sublimation rate and condenser capacity<br />
cooling rate, coldest condenser temperature<br />
leak test<br />
redundant compressors, vacuum pumps, heat exchangers<br />
CIP, SIP<br />
Computer and Software Validation<br />
<br />
Data acquisition, back up, retrieval strategy<br />
‣ Numeric or graphical data as official cycle data, alarms<br />
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