Cleaning validation criteria for colour products

#1

In cleaning validation in pharma industry different criteria used for cleaning validation like, solubility mg/ml,
by sulubility rating worst case product by followed its product carryover.

but for coloured product which criteria and method used for cleaning validation

Regards
Narendra

#2

As far as I know, there is no criteria for colors because APIs are taken in worst cases but no excipient or color.

#3

If API itself is with color like yellow, then what are the criteria to be considered for cleaning validation…

#4

Visual inspection the only criteria.

Visible Residue Limit (VRL)The limit below which a residue is not visible under defined parameters as Distance
Ambient Light Intensity
Viewing
Angle
Residue appearance

  1. Distance The viewing distance is the distance between the equipment surface and the observer’s eyes Defined for consistency ( 1 feet for clinical and 5 -20 feet for commercial )
    2.Ambient Light Intensity Light under which VRLs observedPerpendicular (90°) to surface Defined at set levelDefined as intensity range 100–1400 Lux
    3.Viewing AngleThe viewing angle is the angle between the flat equipment surface and the observer’s eyes (150-900)
1 Visual Inspection:
1 Equipment shall be treated as visibly clean when cleaned equipment shall be free from visible residue, dust, fibers, any stain or discolorations and any abnormal surface anomalies after cleaning.
2 Equipment should be checked for visually cleanliness after completion of cleaning activity followed by drying with naked eye or using flash light, usage of torches, mirror etc.
3 It is necessary to ensure that equipment is visibly clean prior to collection of cleaning validation sample.
.4Visually inspect the final rinse and sample rinse of each part of equipment to ensure that it is clear and colorless.
.5 Operators shall be trained for accessing visual cleaninliness for observing and identifying drug substance at low concentration

Thanks