Reg Dirty Cleaning of the equipment i need to develop dirty hold time study what is the process please help i need to prepare a protocol and report and how long can i monitor if the equipment is idle
You can considered 48 Hours.
During dirty equipment hold time study u have to consider following,
- You have to mention the rationale for selection of products which is more prone to growth of microorganisms.
- Selection of equipment which is critical and having more processing time.
- selection of micro sampling location after every interval e.g 0 , 12, 24, 36, 48 and 72 hrs
- after last hours sample send then clean as per product change over cleaning and after cleaning also send swab sample for API and microorganisms residue.
- summary if you have selected critical equipment during study same study can be extrapolate to other equipment.
According to my understanding, all the equipment used during the manufacturing of a product should be considered for the “Unclean (dirty) hold time” of equipment. There is no need to select the critical equipment. This is because Dirty hold time may be different for different equipment.