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Friday, October 31, 2008

Procedure for Cleaning of Production areas after Batch to Batch change over

1.0 OBJECTIVE
To lay down a procedure to keep all production areas free from traces of previous Batch of same Product and Strength.
2.0 SCOPE
This SOP is applicable to Pharmaceutical Production area
2.1 AREAS
Dispensing 1,2 , Module -1,2,3 and Packing Machine rooms.
3.0 RESPONSIBILITY
Concerned Operator
4.0 ACCOUNTABILITY
Production Officer.
5.0 PROCEDURE
5.1.0 Precautions
5.2.0 Equipments and Tools
5.3.0 Cleaning agents.
5.4.0 Disinfectants
5.5.0 Operation
5.1.0 Precautions
5.1.1 While cleaning the walls and floor do not use strong smelling disinfectants.
5.2.0 Equipments and Tools:
5.2.1 Vacuum cleaner
5.2.2 Scrubbing machine
5.2.3 Ordinary mop.
5.2.4 Lint free duster.
5.2.5 Glass cleaning cloth
5.2.6 Sponge rectangular.
5.2.7 Aluminium ladder of suitable size
5.3.0 Cleaning agents:
5.3.1 Alklean as is
5.3.2 Window shine glass cleaner as is.
5.3.3 No rinse hard surface cleaner as is
5.4.0 Disinfectants:
5.4.1 Jeplon - 1 part to 100 parts of water
5.4.2 Dettol H - 1 part to 100 parts of water
5.4.3 Fairgenol - 1 part to 10 parts of water.
5.5 Operation
5.5.1 Aluminium door and wall fittings
5.5.2 Dust and wipe the glove boxes, hanger rod, slipper stand and Return Air Ducts in gowning area
5.5.3 Dust and wipe aluminium doors and glasses in all areas.
5.5.4 Vaccum clean all the Return Air Ducts in above areas.
5.5.5 Floor
5.5.6 Vaccum clean the floor along with Return Air Ducts in all Production areas when ever there is batch to batch change over.
5.5.7 Clean the entire floor with the cleaning agent given, followed by mopping with the diluted disinfectant solution accordingly with the help of Scrubbing Machine.
5.5.8 Waste - Bin
5.5.9 Empty the waste bin into polythine bag, tie the bag with a nylon string and keep it ready for collection at collection point.
5.5.10 Clean and replace the lining (twice in a day).
5.5.11 The extra cleaning tasks are carried out whenever there is batch to batch change over .

1 comment:

Thomas Sam said...

How long can a betch run or what is the idal time for batch run considering the Batch to batch cleaning requirements.