Dirty & Clean Equipment Hold time Study

[@nikhilverma1560]

Sir please tell me the acceptance criteria of clean equipment hold time study

[@pharmaceuticaltechnicaltal7075]

For CEHT initial day, Chemical swab limit is to be considered same as cleaning validation or may be calculated based on individual equipment wise approach. In future I will create one short video for it.

[@Chikuonline]

CEHT in one batch or three batch

[@pharmaceuticaltechnicaltal7075]

One batch is enough because we have not produced anything. Three batches required only when we produced product to know the consistency. So only one batch is enough..

[@Chikuonline]

What is bioburden limit in CEHT? Is periodic verification required in CEHT? What to do if DEHT exceed during routine manufacturing.

[@Chikuonline]

Granulation, compression, coating all three area we have to perform cleaning validation or only one equipment is sufficient?