Campaign Cleaning Validation

[veensent25]

My company has a liquid dosage product that we are doing a campaign manufacturing and we need to do Cleaning Validation. Usually, we will do a batch to batch manufacturing within the week. For Cleaning Validation, we are taking about 2 weeks for the Manufacturing and Equipment Hold Time. For Dirty Equipment Hold Time, we intend to flush and drain out the liquid and hold the equipment for 3 days as the ingredients we dealing with can cause the equipment to be sticky and impossible to clean if we hold it for too long. Is there any concern about this? Those who have experience with Campaign Manufacturing with Cleaning Validation, please feel free to let me know about your experience in these areas. Thanks!

 

[v9991]

Usually, we will do a batch to batch manufacturing within the week. For Cleaning Validation, we are taking about 2 weeks for the Manufacturing and Equipment Hold Time. For Dirty Equipment Hold Time, we intend to flush and drain out the liquid and hold the equipment for 3 days as the ingredients we dealing with can cause the equipment to be sticky and impossible to clean if we hold it for too long. Is there any concern about this? Those who have experience with Campaign Manufacturing with Cleaning Validation, please feel free to let me know about your experience in these areas. Thanks!

as long as the the process of "flush & drain" is defined and implemented as standard process of batch manufacturing, that is not going to be concern;
and the confidence and reliability is through addressing those attributes through the risk assessment., consider following points in the context of hold time...

Ensure you have data to demonstrate that the following variables do not impact cleaning effectiveness:

1. The length of time between the completion of manufacturing and start of cleaning (dirty hold time).
2. The maximum allowable number of batches of the same product manufactured prior to full cleaning, specifying maximum campaign lengths in days and/or number of batches.
   
   Ensure that microbiological assessments are considered, as per risk management principles, when assessing maximum campaign lengths
   
   
   

3. 1. Cleaning validation guide (GUI-0028) - Canada.ca

another useful reference.,

Cleaning Validation: The Definitive Guide in 2023 - Pharma GxP

This article explains the overall cleaning validation program and the factors that play around it. Also, you'll see regulatory requirements for cleaning validation.

pharmagxp.com