Hold time studies in cleaning validation

Hello there,

I am performing hold time study for filter bag of fluid bed dryer. In the previous study, my ex-colleagues concluded that the clean hold time is 15 days. I am new to cleaning validation and this makes me confused:

  • What is the strategy for conducting the clean hold time study? I mean which day(s) should be selected to sampling? I see some companies choose days 1st, 3rd, 7th and 15th, but I really don’t know what is the basis of these selection.
  • What if the test results show the presence of microorganism in the day 7th and their absence in the day 15th? If we conclude that the clean hold time is 15 days, then we manufacture drugs in the day 10th, how can we assure that our products will not be contaminated?

Thank you for taking the time to look into my matter.

Best regards,

Tri

In cleaning validation, hold time study of FBD bag, you have studied 15 days, there is no bio load identified, so you have to use the bag in within 10days , so there is no problem for the bio load issue.
Why because we are selecting the worst case locations to find out the bio load. on the stringent basis 10days is allowed to use the FBD bag.

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Case -1
If you scheduled hold time on Initial, 2nd day,7th day, 10th day,14th day, 21th day,28th day and all hold time having satisfactory result we can select 21 day as hold time.
Case -2
If you scheduled hold time on Initial, 2nd day,7th day, 10th day,14th day, 21th day and all hold time having satisfactory result we can select 14 day as hold time.
Case -3
If you scheduled hold time on Initial, 2nd day,7th day, 10th day,14th day and all hold time having satisfactory result we can select 10 day as hold time.

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Hi dushyant3044,

Thank you for your suggestion. Could you please tell me the basis of your selection? For example, in case - 1, why don’t you choose the day 14th instead of 21st?

Could you please show me guidelines for those cases?

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In case 1- if there is no microbial growth after 28 days you can choose hold time 21 days as safer side.As in case of sterilized item if we found satisfactory result for 72 hrs.we can consider 48 hour as hold time of sterized item.

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Hi manojsingh,

If my sampling schedule is ‘Initial, 2nd day,7th day, 10th day,14th day, 21st day,28th’, the test result shows the absence of microorganism in the day 14th but they appear in the day 21st. So which hold-time period should be choose? 7th or 10th?

As Mr. Manoj suggested with safer side. We should always proposed thorugh that manner only.

Hold study evaluation plays a main role for manufacturing the pharam formulations. Based on the hold time study establishment and shelf life product manufacturing plan can be decided. Hold time study results are passing the 60 days time interval then 45 days limit is good for general practice. In the same way you can select quantum too.

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Respected Dushyant Sir,
thanks its a good information.
actually I m belonging from API manufacturing.

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