Hi my name is Michele Volpe and I am an avid reader of ghisa forum. I have a question about the “holding time”. If I have, for example, three tanks, which are identical, which have the same CIP recipe (PQ validated by three runs for each tank), with the same storage conditions before and after Cleaning activities and within which I use the same product (blood product) can I performance a Holding Time study (CEHT and DEHT) on one only tank and extend the results on the other two tanks? Thanks in advance for your kind reply.
You can do that provided both tanks are used for similar purpose with similar design,Operation, Connectivity, Handling, cleaning procedures and cleaning systems.
Any deviation in any of the elements above said would cause a disaster if its not validated for hold time. In such a deviation you ought to perform studies independently.
Regards
hi,
kdly provide inf that during DEHT study swab samples collected before cleaning or after cleaning. because we have procedure for use dirty equipment upto three days for same product.
and during DEHT study swab samples for only microbial analysis is sufficient for study.
Regards
ANIL SAXENA