A general outlay of Hold time protocols were described here.
In these both protocols worst case was not described.
You can use this document for your protocols and worst case Hold time studies too.
Hold time-1.doc (128.0 KB)
Hold time-2.doc (121.5 KB)
Dear Sir,
Can we set the acceptence criteria for equipment hold time as:
Microbiol count : 25 cfu/25 cm2
Yeast & moulds : 5 cfu / 50 cm2
E.Coli : absence / 25 cm2.
This hold time study for non sterile products manufacturing equipments and located in Grade D clean area.
I am not sure about Yeast and moulds acceptence criteria.
We are looking our experts valuable feedback in this view. Kindly correct me if it is wrong.
Thanks in advance.
Pulla Reddy Karnati.
You can change based on your necessity, suitability and regulatory acceptance.
There are no definitive rules that one to stick to the above enclosed protocol.
I totally understand your question.
There is a bigger question regarding yeast and moulds.
In the Hold time study guidance recently that was drafted by WHO for inspectors says a Microbial Test to be performed.
I posted this document in QA section.
Now the bigger question is that about “D” area.
What are normal limits of Microbial and Fungal detection limits you have “D” class area is a subject of interest to regulatory agencies.
The problem comes when you delete testing criterion on these in Hold Time studies and still keep testing for environmental monitoring purposes and document them based on your flexibility.
As you pointed out on this, I would suggest that one should look both criterion rather than just deleting in Hold time studies.
If it is applicable to area it is also applicable to product exposed and manufactured in that particular area.
You need to take a call as per procedure you follow and also keep regulatory compliance in place.
See hold time protocol here
Dear Sir,
Thanks a lot the protocol is very helpful
Regards
Swapnil thorat