Change
over cleaning activity shall be separate in three different level based on
their criticality. This approach is outlined in the below.
Level 2 is indicating that cleaning validation is essential and must be performed for product changeover from API A (Previous Product / Product to be cleaned) to API B (Product to be taken / Next Product).
Level 1 is indicating that cleaning verification shall be performed for intermediates changeover.
Level 0 is indicating that gross cleaning shall be performed for sequential intermediates changeover of API.
|
Level
|
Thoroughness
cleaning
|
Cleaning
Validation
|
Example
|
|
2
|
Carryover
of previous product is critical.
|
Essential
/ Must
|
API
A àAPI B
|
|
1
|
Carryover
of the previous product is less critical
|
Necessary
|
Crude
API A à Intermediate of API B
|
|
0
|
Carryover
of the previous product is sequential earlier stage of API
|
Not
required, only gross cleaning shall be done
|
Crude
API à API A
|
Level 2 is indicating that cleaning validation is essential and must be performed for product changeover from API A (Previous Product / Product to be cleaned) to API B (Product to be taken / Next Product).
Level 1 is indicating that cleaning verification shall be performed for intermediates changeover.
Level 0 is indicating that gross cleaning shall be performed for sequential intermediates changeover of API.
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