OBJECTIVE
To lay down a procedure for cleaning of the octagonal blender.
SCOPE
This procedure applies to the production department in the Pharmaceutical Manufacturing Facilities Formulation division. This procedure covers the cleaning of the Octagonal blender.
RESPONSIBILITY
The Blender operator is responsible for the implementation of the process.
The production supervisor is responsible for the execution of the procedure.
The production manager has to ensure compliance
PROCEDURE
Type “A” Cleaning Procedure
This procedure has to be followed at the time of:
- Batch-to-batch changeover
- From lower to higher strength
- At the end of the day
Ensure that the status label is updated as “TO BE CLEANED”.
Ensure that the blender main is switched off before cleaning.
Remove labels, materials, and containers of the previous batch from the blending area.
Remove any adhering material from the outer surface of a blender.
Dry clean the parts like the body surface, clamps, and lid, by using dry lint-free cloth.
Ensure complete cleanliness visually.
Update the status label as “Cleaned”.
Type “B” cleaning
This procedure has to be followed at the time of:
- Product-to-product changeover
- From higher to lower strength
- Change in color
- After any major breakdown or preventive maintenance
- After continuous production of 6 days (of the same product)
- If equipment is idle for 7 days from the date of cleaning or before the use.
Affix the status label “TO BE CLEANED” on the equipment.
Ensure that blender mains are switched off before cleaning.
Update the status as “Under Cleaning” on the display board.
Dismantle the rectangular lid by unscrewing the clamp, gasket and bowl of blender.
Cleaning of Main Body
Any adhering material from the octagonal blender shall be removed and covered the electrical fixtures and control panel with a polythene bag.
Close the rectangular lid and fill the blender with approximately 100 liters of potable water and switch on the blender and rotate for about 3 to 5 minutes.
Inch the blender and position to collect the rinse water directly to the SS container after opening the lid and discard in the drain.
Apply approximately 200 ml of liquid detergent and scrub the inner and outer surface, with the help of a nylon scrubber for over a period of 5-10 minutes.
Flush with approximately 75 liters of potable water until no adherent powder and detergent residues are observed.
If any visible residue or adherent material is found repeat the above steps.
Finally, flush the equipment using approximately 50 liters of purified water.
Ensure thorough cleaning of the inner and outer surfaces of the blender.
Wipe the inner and outer surfaces of the blender using a dry lint-free cloth.
Cleaning of blender parts
Transfer the dismantled rectangular lid, bowl, clamp and gasket in a duly covered polythene bag after affixing the “TO BE CLEANED” label using the SS trolley.
Give initial rinse to parts using approximately 25 liters of potable water.
Apply approximately 50ml of liquid detergent to all parts and scrub with the help of a nylon scrubber for over a period of 3-5 minutes.
Wash the parts using approximately 50 liters of potable water till the equipment part is visibly free from powder and detergent residues.
If any visible residue or adherent material is found repeat the above steps.
Ensure thorough and complete rinse of the total surface of each equipment part by suitably keeping it on both sides and tilting sideways as appropriate using approximately 30 liters of potable water.
Give the final rinse with approximately 40 liters of purified water to all parts.
Dry the parts using a dry lint-free cloth.
Transfer the cleaned parts to the cleaned equipment area duly covered in a polythene bag using an SS trolley after fixing the “CLEANED” label.
Assemble the dismantled parts in the reverse order of dismantling.
Update the status label as “CLEANED”.
Record the entry in the equipment cleaning logbook.
ABBREVIATION
Q.A - Quality Assurance
SCP - Standard Cleaning Procedure
No. - Number
P.D - Production
ANNEXURE
Nil
REVISION HISTORY
Nil
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