Cage Blender Operational SOP in Pharmaceuticals

Standard Operating Procedure of Operational Cage Blender in pharmaceuticals is describe in this post.

1.0 Purpose

1.1 To lay down the cleaning and operation for Cage blender.

2.0 Scope

2.1 This SOP is applicable for Cage blender used for blending.

3.0 Responsibilities

Operator/ Officer Production

Executive Quality Assurance

4.0 Definition and Abbreviations

4.1 BMR : Batch manufacturing Record

4.2 SOP   : Standard Operating Procedure

5.0 Material and Equipment 

5.1 Gravity pipe.

5.2 Water

5.3 2% non ionic detergent

5.4 Purified water.

6.0 Safety Consideration

7.0 Procedure

7.1 Cleaning Procedure for product changeover

7.1.1 Ensure that ‘To be Cleaned’ label is put on the equipment

7.1.2 Ensure that the mains are switched ‘OFF’

7.1.3 Ensure that the bunker is transferred to respective OHCR room.

7.1.4 Clean the drive unit with moist clean duster followed by dry clean duster.

7.1.5 Clean and ensure the cleanliness of the equipment surrounding area.

7.1.6 After completion of compression, loosen the clamp and separate the Bunker (Cage/mixing bowl) from material transfer gravity pipe.

7.1.7 Ensure that the bottom butterfly valve of the bunker is closed.

7.1.8 Take bunker and material transfer gravity pipe to the washing area.

7.1.9 Open the top lid of the bunker, wash inside outside of the bunker, material transfer gravity pipe and top lid with 40 liters running potable water followed by liters of 2% non ionic detergent solution using long and hard nylon bristle brush.

7.1.10 Rinse all above parts with 80 liters running potable water to remove detergent.

7.1.11 Finally rinse all above parts with 80 liters Purified water.

7.1.12 Clean the material transfer system as per SOP under head cleaning procedure for product changeover.

7.1.13 Visually ensure the cleanliness of the equipments.

7.1.14 Intimate QA to wash water sample and wait for approval.

7.1.15 On receipt of QA approval, dry all the parts using filtered compressed air /hot air blower.

7.1.16 Remove ‘To be cleaned’ label and affix duly signed ‘Cleaned’ label.

Note: the cleaning of the equipment remains valid for 48 hours. If the equipment is not used within 48 hours then it should be re cleaned as per above procedure starting from starting from step 5.1.4.

7.2 Cleaning procedure for batch to batch to batch changeover

7.2.1 Ensure that ‘To be Cleaned’ label is put on the equipment.

7.2.2 Ensure that mains are switched ‘OFF’

7.2.3 Ensure that the bunker is transferred to respective room.

7.2.4 Clean the drive unit with dry clean duster.

7.2.5 Clean the material transfer system as per SOP under head ‘Cleaning procedure for batch to batch changeover’.

Note: the cleaning of the equipment remains valid for 48 hours. If the equipment is not used within 48 hours then it should be re cleaned as per cleaning procedure for product changeover.

7.3 Operating procedure

7.3.1 Checks and precautions

7.3.1.1 Wear hand gloves, over coat and nose mask during the sifting operation

7.3.1.2 Ensure that safety railing is locked properly.

7.3.1.3 Ensure that the bottom butterfly valve of the bunker is closed.

7.4 Operating procedure

7.4.1 Remove ‘Clean’ label and affix it in the BMR.

7.4.2 Affix ‘Under Process’ label on the equipment.

7.4.3 Fix the bunker to drive unit with the fly nut. Ensure that the fly nuts are properly locked.

7.4.4 Fix the material transfer system on the top open part (material charging port) of the bunker.

7.4.5 Switch ‘ON’ the mains and operate the material transfer system as per SOP to charge the material to be lubricated into the bunker.

7.4.6 After completion of the material charging, remove aside the pneumatic conveying system.

7.4.7 Fix bunker lid in place of material transfer system and lock with fly nut Ensure that the lid is securely locked.

7.4.8 Lift the bunker by operating Push button marked ‘UP’.

7.4.9 Remove bunker trolley and lock the safety railing properly.

7.4.10 Set the timer for total blending time as per BMR.

7.4.11 Start the blender by operating push button marked ‘Blender ON ‘ to rotate the bunker.

7.4.12 After completion of the blending cycle, bring the bunker in balanced position by operating in inching mode.

7.4.13 Unlock the safety railing, insert bunker trolley and take down the bunker. Restore it on the bunker trolley.

7.4.14 Unlock the fly nut and separate the bunker from drive unit.

7.4.15 Weigh the bunker, note down the reading and transfer it to concerned room or granules quarantine awaiting compression.

7.4.16 Remove ‘Under process’ label and affix to be cleaned’ label.