Production sterile area

Max holding time for storage tank in Formulation
When filling m/c stoped for along time

Please note that based on"Hold time" studies conducted on bulk product stored in storage tank of formulation, you will have to decide. Generally Holdindg period of each formulation (at different stages) is established at the time of process validation.


if hold time of bulk solution expired due to some reason , should we discard the bulk solution?

When hold time of bulk soultion in storage tank exceeds (expires) additional tests reflecting quality characteristices should be carried out to ascertain effect of extended hold time, such as microbial limit tests, stability of solution in bulk (chemical, physical parameters checks) or sterility / endotoxin test depending upon product type (Non-sterile / sterile) . Sometimes, it may be required to re-filter the bulk solution. If the additional tests are satisfactory then the bulk solution can be released for filling / further processing step.

Batch of finished product made from intermediates or bulk product (bulk solution) which are subjected to an extended hold-time (deviation in hold time) should be considered for long-term stability testing to evaluate if data shows adverse trending or shifting patterns during the intermediate time points up to the end of the shelf-life.

Simultaneously, an investigation must be carried out to identify the root cause of deviation in hold time. Is it due to poor production planning or due to unavoidable reasons (such as breakdown of machine or malfunctioning of filling line). Based on this CAPA actions should be identified and implemented.


Thanks for your explanation. In such a case if it’s possible to release the batch to the market or not?

It can be release to the market provided- it complies with the finished product specification, incident is closed, proper CAPA is taken and sample taken for ongoing stability study.