Pls clarify me ,
For tablet mfging facility----
Amount of solvent ( water ) used for cleaning a equipment … is it needs to be validated in preparing the SOP for cleaning of particular equipment .
Suppose we are giving the first wash of potable water then purified water .
Is it neccessary to justify the amount of water used?
Is it neccesary mention it in Cleaning validation protocol or SOP?
Flow rate is required to be specified?
As it will vary from equipment to equipment , operator to operator,
material to material, manual to CIP cleaning as applicable.
Also the time may vary … so is it to require to specify?
Is there any experience that auditors have asked about it?
Expecting quick replys,