Hi!
Is it normal to validate how long we can store a cleaned tank before it needs to be cleaned again?
How is this done?
Cheers
Loke
[quote=KY Loke]Hi!
Is it normal to validate how long we can store a cleaned tank before it needs to be cleaned again?
How is this done?
Cheers
Loke[/quote]
Dear KY Loke,
yes it is normal practice to validate the holding time for a clean tank.
This can be based mostly on bioburden control. You can set a period of time (say tests every 24 hours after having the tank cleaned). Therefore, you will end up with a period of time such as say 72 hours. This information must be also stated (after the conduction of the relevant validation) to the corresponding SOP for cleaning the specific tank.
Hope this helps.
Best regards,
Thanks for the info.
[quote=KY Loke]Hi!
Is it normal to validate how long we can store a cleaned tank before it needs to be cleaned again?
How is this done?
Cheers
Loke[/quote]
I want to add up somthing here actually clean equipment Hold time is the time elapsed from the end of the cleaning process until the beginning of the use of the cleaned equipment for manufacture of the next product and the dirty equipment hold time is the time start from the end of manufacturing to the begining of the cleaning process. Now a days auditor may ask u abt the status of cleaning (Ready to use) and its holding time and does the cleaning SOP describes how long the cleaned equipment can be stored prior to re-cleaning?. History of cleaning log books is also checked to assure the proper hold time before and after cleaning. so all in all it should be established during Cleaning validation and not to be overlooked.
Good info. Thanks
Is it also makes important what type of cleaning agents do you use? and waht are your storage conditions after cleaning ??
vishwesh
[quote=vishwesh2007]Is it also makes important what type of cleaning agents do you use? and waht are your storage conditions after cleaning ??
vishwesh[/quote]
Type of cleaning agents:
It all depends how you approach Post Clean Hold Times (PCHT) or as some people call it Clean Equipment Hold Times (CEHT). If you are applying a matrix or bracketing approach it possible that you might have to speak about the cleaning agents or better yet the cleaning process. The reason being is that organic product residues may not be completely absent from the cleaned equipment, even though it have been proven from previous cleaning validations to be reduced to acceptable levels (i.e. < 10ppm). The trace amounts of product residue may serve as organic nutrients for microbes, and thus promote microbial growth. So an evaluation of carryover values from previously performed validations may need to be complied and evaluated where you might contribute a particular cleaning process to a worst case scenario.
If you are challenging a single piece of equipment I would say no.
Storage Conditions:
Absolutely, equipment storage conditions and room qualifications are very important. Since most equipment after cleaning is not absolutely dry, there is potential for recontamination of equipment during its clean hold time from dust particles or airborne microbes that can contribute to microbial proliferation when combined with the moist surfaces of the equipment.
Again these are only my opinions
PVAL