Hold time study in cleaning validation

Hold time study for clean and unclean equipments must be carried out during cleaning validation. It’s one of important aspect that many pharma companies forget to do Hold time study for clean and unclean equipments during Cleaning Validation.

What is Clean equipment hold time dirty equipment hold time ?

During validation of cleaning procedures, hold time study of dirty equipment and clean equipment is studied.

Clean equipment hold time is the time period for which the cleaned equipment after cleaning is stored as per the SOP instructions, and it is the best time period by which the cleanness of the cleaned equipment is maintained, both microbiological count and status of cleanness due to storage.

A cleaned equipment is required to be covered with a clean polyethylene bag and sealed, and during its storage for intermittent period cleanness and microbial count over the surface of cleaned equipment is studied.

It is the time by which there is a visual deposition of dirt or the increase in the bacterial and fungal count over the cleaned equipment when done with swab testing goes up, at that period just before that equipment should be taken for re-cleaning, this period for safety can be curtailed to the previous microbial sample which are complying and visual inspection too is complying.

In the pharmaceutical industry a time period of 7 days to 14 days for cleaned equipment depending on the size of the equipment and storage condition is assigned.

Unclean equipment hold time:

In case of unclean equipment, it is observed that by holding the uncleaned equipment for a particular period. 1) The dirt doesn’t firmly fix on the surface after drying and makes it difficult for cleaning 2) It does not contaminate the other product by virtue of its storage which may hamper the movement of the equipment storage space required for other products. Manufacturer has to decide on this as this may result in a source of cross contamination, therefore a dirty equipment hold time normally is decided to 3 days and maximum up to 7 days.

All the problems with dirty equipment on hold should be verified and corrected during the validation of the cleaning process then the entire process becomes practicable and easy to follow.

Reference: https://www.fda.gov/drugs/guidances-drugs/questions-and-answers-current-good-manufacturing-practice-regulations-production-and-process#1