Do any body is having PQ protocol for pure steam ?
PQ protocol contains same specification test as that of WFI like description , Nitrates, heavt metals, bacterial endotoxin, acidity or alkalinity, calcium . chlorides, sulphates, TOC, conductivity, pH, carbon dioxide, total viable counts , pathogen testing. include these test in protocol and limits will be drawn as per QC- Micro specification at ur site.
This protocol covers the Performance Qualification of the pure steam generator system in room XX
Blank Pure steam PQ 2003.doc (222.5 KB)
Nice drafting with valuable contents.
Thanks for sharing.
This document is very useful for certain aspects of steam quality testing. However there are serious omissions that in effect mean that you have not validated the steam quality attributes that ensure steam is capable of being used as a sterilizing agent.
Many years ago hospitals’ and clinics were damaging patients by not recognising that dry steam did not sterilise to the same efficacy as wet steam and that none condensable gases could create pockets within an load that did not reach and hold the required sterilising conditions.
A thorough investigation revealed that none condensable gases, steam superheat and steam dryness fraction are all capable of affecting steam’s ability to sterilise 100% of a load 100% of the time. Since these attributes could all be affected by design and or deteriorating, pipes, valves, tanks, nozzles and many other aspects of the steam generation and distribution system, it became mandatory that these attributes were validated on completion of all initial installations and were then subjected to annual re-qualification.
Further details are available here
Thank you for your sharing,it’s good!
do you have PQ protocol for lyophilizer? its urgent
Hi everyone, is someone able to explain if you create the PQ protocols for HVAC or compressed air? thanks!