Cleaning Validation Protocol of Freeze Dryer

TITLE Cleaning Validation Protocol of Freeze Dryer 

The purpose is to validate the cleaning procedure and ensure that residues of previous product are removed in accordance with the maximum allowable carryover limit calculated, as well as other tests, i.e., visual inspection, pH, conductivity, and TOC. 

Quality assurance inspector/machine operator and QC analyst are responsible to follow the procedure. The quality assurance (QA) manager is responsible for SOP compliance. 

The cleaning validation protocols are applicable to the freeze dryer chamber, including  

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