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Validacija čiste pare in preverjanje končnega izpiranja v postopku čiščenja na mestu (CIP) sta opredeljena s predpisi. Ker se ti predpisi redno spreminjajo, morajo oblikovalci in lastniki sistemov poznati najnovejše zahteve.
Ta bela knjiga ponuja vpogled v trenutne predpise in priporočila za validacijo čiste pare in preverjanje končnega vodnega izpiranja v postopku CIP.
Članek vsebuje pregled zahtev farmakopeje, ki bodo pomagali pri načrtovanju in spremljanju sistemov za proizvodnjo čiste pare in CIP.
The first part of the paper looks at the requirements for Pure Steam. The second part concerns the requirements for validating the final rinse of a clean-in-place process in which Pure Steam, pharmaceutical grade water, or chemical cleaning has been used.
Regardless of the method, all require an aqueous final rinse and verification. Verifying the final rinse confirms that the previous steps in the process have achieved the desired goals and allows equipment to be returned to service.
Continuous monitoring of total organic carbon (TOC) and conductivity provides the necessary information for confirming Pure Steam quality and CIP final rinse verification.
.png/_jcr_content/renditions/cq5dam.web.1280.1280.png "Linijska pH Sonda/ORP (redoks) sonda")
.png/_jcr_content/renditions/cq5dam.web.100.100.webp "Senzor prevodnosti/senzor upornosti")
.png/_jcr_content/renditions/cq5dam.web.100.100.webp "Oddajniki")