Friends,
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?
the amount of water for cleaning the equiment has to be set during the development of the cleaning procedure, and stated in the cleaning SOP, which is then validated with the cleaning validation (actually, the cleaning validation is a process validation of the process described in the cleaning SOP).
The amount of water used needs no “justification”, as long as it is enough to ensure cleanliness. If you use too much water, it is only an economic, but not a regulatory concern. What has to be set is the minimum amount.
It is absolutely neccessary to mention it in the cleaning SOP. The cleaning validation protocol can then reference the SOP.
The flow rate, once determined during the development of the cleaning procedure, needs to be specified in the SOP and kept constant. As it is not practical to equip every tap with a flow meter, what we have done is to specify in the procedure the tap where the water has to be taken from (because the flow rate may vary between different taps), and the time the water has to be kept running with the tap completely open. The cleaning SOP is specific for each piece of equipment. A cleaning SOP that has no specification for water amounts is inadequate for auditors. For manual cleaning, each cleaning validation run includes a process verification, checking if the operator follows the steps and specifications of the cleaning SOP.