Saturday, September 20, 2008


To carry out the mixing operation in a clean equipment according to the requirement of GMP.
Cleaning Materials
Cleaning agents : Tap water
Cleaning equipments : Dry duster, 0.1% Teepol
Disconnect the equipment from electrical main supply

Set the position of the blender vertical- butterfly value facing the floor.
Cleaning Procedure (For Product to Product Change Over)
Dismantle the safety guard of the blender, circular lid and gasket by unclamping the wing nuts
Clean the outside of the blender with dry duster followed by moist duster and then with dry duster.
Keep the butterly valve close and keep an SS container below it.
Wash inside the blender with tab under and drain it through butterfly value
Clean inside surface with warm water 40°C to 50°C followed by 0.1% teepol solution. Then wash with plenty of water to remove the teepol completely, then rinse with water.
Wipe the different parts of the blender with clean lint free duster.
Then assemble the dismantled parts.
For Batch to Batch Change Over
Dry clean the blender & lids with lint free duster and dedust the external surface with clean lint free duster.
If the cleaned blender is not used with in 24 hours after cleaning, outside of the blender and the lid should be wiped with wet duster followed by clean lint free duster
Cleaning Schedule
The equipment should be cleaned before and after every product to product and batch to batch change over. As per the above given method.
Status label
Display the “Cleaned and Ready for Use” status label after cleaning the machine.

1 comment:

D.S. Rao said...

During the product change over, collection of "swab & rinse" samples to be specify for content of previous product by suitable analytical method along with specification level.
Otherwise, the operator/chemist unable to understand the level of cleanliness.

D.S. Rao