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SOP for Cleaning Procedure of Octagonal Blender

OBJECTIVE
To lay down a procedure for cleaning of octagonal blender.

SCOPE 
This procedure applies for production department in Pharmaceutical Manufacturing Facilities Formulation division. This procedure covers cleaning of Octagonal blender. 
RESPONSIBILITY 
  • The Blender operator is responsible for implementation of the process. 
  • The production supervisor is responsible for the execution of the procedure. 
  • The production manager has to ensure the 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 status label is updated as “TO BE CLEANED”. 
  • Ensure that blender main is switched off before cleaning. 
  • Remove labels, materials and containers of previous batch from the blending area. 
  • Remove any adhering material from the outer surface of blender. 
  • Dry clean the parts like body surface, clamps, lid, by using dry lint free cloth. 
  • Ensure the complete cleanliness visually. 
  • Update the status label as “Cleaned”. 
Type “B” cleaning 
  • This procedure has to be followed at the time of: 
  1. Product to product changeover 
  2. From higher to lower strength 
  3. Change in colour 
  4. After any major breakdown or preventive maintenance 
  5. After continuous production of 6 days (of same product) 
  6. 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 cover the electrical fixtures and control panel with 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 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 inner and outer surface of the blender. 
  • Wipe the inner and outer surface of blender using dry lint free cloth. 
Cleaning of blender parts 
  • Transfer the dismantled rectangular lid, bowl, clamp and gasket in duly covered with polythene bag after affixing “TO BE CLEANED” label using SS trolley. 
  • Give initial rinse to parts using approximate 25 liters of potable water. 
  • Apply approximately 50ml of liquid detergent to all parts and scrub with the help of nylon scrubber for over a period of 3-5 minutes. 
  • Wash the parts using approximate 50 litres 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 the sides and tilting sideways as appropriate using approximately 30 liters potable water. 
  • Give the final rinse with the approximately 40 liters of purified water to all parts. 
  • Dry the parts using dry lint free cloth. 
  • Transfer the cleaned parts to cleaned equipment area duly covered in polythene bag using SS trolley after fixing “CLEANED” label. 
  • Assemble the dismantled parts in the reverse order of dismantling. 
  • Update the status label as “CLEANED”. 
  • Record the entry in equipment cleaning logbook.
ABBREVIATION(s) 
Q.A - Quality Assurance 
SCP - Standard Cleaning Procedure 
No. - Number 
P.D - Production

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