we have established clean equipment validity 72 hrs. if i am not using clean equipment till 15 days. I have to recleaning equipment every 72 hrs ?? or can i recleaning equipment before use ??
Is the same cleaning procedure effective to clean equipment after 15 days ??u
If clean equipmwnt not used for 15 days then recleaning to be done after every 72 hours followed by collection of rinse water sample.
That’s not required to clean every 72hrs,before use of particular equipment it must has to be cleaned I.e type-B.
It is not necessary to clean after every validity period (i.e., 72 hrs).
It is recommended to clean the cleaned equipment before usage by validated recleaning procedure and sent for rinse water analysis.
It is not necessary to clean after every validity period (i.e., 72 hrs). But if re-cleaning after 15days does not produce result as expected (removing bioburden/microbial particulates, etc.), then it may require to be cleaned every 72 hours or at other frequency depending upon your process requirements. You may adopt double cleaning or triple cleaning in such case.
why 72 hours is established? Is that okay if I cleaned that equipment before use even after 30 days?
72 hours or 30 days - all should be based on cleaning validation data and your process requirements.
why I need to collect rinse water sample?
Under cleaning validation or in routine test (if included in/required by SOP), rinse water samples or swab samples (from the surface) are taken from at the last stage of the cleaning to find out whether API/product residues, cleaning agent (detergent) residues, etc. on the surface after cleaning are within specified acceptable limit. You may like to google it for more details.
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1.it’s not necessary to clean the equipment after cleaning validty expires,the equipment goes to to be cleaned status after clening validity.
2.It is recommended to clean the cleaned equipment before usage of equipment as per cleaning sop.
You should establish dirty hold time (DHT) hold time. You cant put any equipment dirty for 30 days without DHT.
Your cleaning validity should be define lesser than the established time.
If your cleaning validity is defined for 72 hours, it is to use the equipment within the time line (72 Hrs.) if not used within 72 Hrs. not required to clean every 15 days, Equipment to clean before use.
it doesn’t make any sense to clean the equipment every 15 days, if it is not used for the 72 hours.
Yes right i agree with Pragnesh sir.
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Dear Vilesh bhai
Why you assign re cleaning frequencies 72 hours because it is based upon microbial bacterial load generated up to 72 hours .So you need to clean equipment after every 72 hours as a validated cleaning frequencies
No need to clean after 72 hrs or cleaning hold time over.but you need to clean I.e type -B before using that particular equipment.