My query is regarding presence of endotoxin in grade Ci.e,component preparation.if it so how can we mitigate it's risk bcz we can't use grter than 300 in that area?

GOOD VALIDATION PRACTICE (cGVP) CLEANING VALIDATION
1

Endotoxin mitigation in grade c

2

If the endotoxin in grade C component preparation area is from an environmental sample, follow the water. Endotoxins are produced by Gram Negative bacterium and Gram Negative bacterium main source is water. Evaluate the area to identify if there is water accumulated on the floor or leaks in the walls/ceiling. In addition, please verify the quality of the water used to prepare the disinfectants since this water can be one vector for endotoxin introduction.

If the endotoxin in grade C component preparation area is from the equipment processed in the glasswasher, the equipment drying process (washer drying cycle and equipment drainability) should be evaluated. Again, follow the water to mitigate risk.

Hope this can provide you some help.

3

Yes and No. In short you have to prove your contention (verification!) and make it relevant to your drug product. Everything is related to your finished drug product and the final limit of 0.25 Endotoxin Units per USP (as I recall).

4

Plz ignore abve msg it’s itnqs 125 instead of 300?