To lay down a procedure for cleaning, equipment line clearance & Operation of the Q mixer
It is applicable for cleaning, calibration, equipment line clearance & Operation of the Q mixer.
Quality assurance officer
4. Cleaning Procedure
Cleaning agents: Purified water
Cleaning equipment: Dry duster, 0.2% Dettol
Cleaning Procedure (For Product to Product Change Over):
4.1 Dismantle the safety guard of the Q Mixer circular lid by unclamping the wing nuts.
4.2 Clean the outside of the Mixer with a dry duster then by moist duster and then with a dry duster.
4.3 Keep the butterfly valve close and keep an SS container below it.
4.4 Wash inside the Mixer with tap water under and drain it through the butterfly valve
4.5 Clean inside surface with warm water 40°C to 50°C followed by 0.1% Dettol solution. Then wash with plenty of water to remove the Dettol completely, and then rinse with water.
4.6 Wipe the different parts of the blender with a clean lint-free duster. Then assemble the dismantled parts.
For Batch to Batch Change Over:
4.7 Clean the Mixer & lids with a lint-free duster and dedust the external surface with a clean lint-free duster.
4.8 If the cleaned Mixer is not used within 24 hours after cleaning, outside of the blender and the lid should be wiped with a wet duster followed by a clean lint-free duster
The mixer should be cleaned before and after every product to product and batch to batch change over. As per the above-given method.
Display the “Cleaned and Ready for Use” status label after cleaning the machine.
5. Q Mixer Line Clearance
5.1 Conform that the area is cleaned as per cleaning SOP.
5.2 Ensure that the Q mixer (Capacity-500 kg) is cleaned as the above-mentioned method.
5.3 Ensure that all containers, documents, and labels of previous product/batch are removed
5.4 Ensure that all the materials and accessories of the previous product/batch are removed.
5.5 Check the Temperature, Relative Humidity RH% and the Differential Pressure of the area and enter the same in the Batch Manufacturing Record.
5.6 Line clearance is given by QA Officer to start the next batch, after checking the above-mentioned points, which is to be recorded in the Batch Manufacturing Record (BMR).
6.1. Check and Confirm that the Q mixer has been cleaned as per SOP.
6.2. Make sure that Line clearance is signed by QA Personnel as per SOP.
6.3. Adjust the angle of the Q mixer to a required position for convenience in loading the materials.
6.4. Load the materials one by one from the container to the mixer as per the sequence specified in the individual Batch Manufacture Record (BMR).
6.5. After loading the materials, close the lid of the mixer.
6.6. Fix the safety pin on the lid and fit it properly within its groove. Lock the mixer lid by moving the wheel in a clockwise direction.
6.7. Before starting the operation ensure that the lid and the safety pin lock have been fixed properly.
6.8. Switch on the mixer and note down the starting time.
6.9. Mix the material as per the time specified in the individual BMR.
6.10 To unload the material, Ensure that the equipment is off.
6.11. Remove the safety guard.
6.12. Adjust the position of the mixer at the required angle for convenience in unloading the materials.
6.13. Remove the lid from the mixer.
4.15. Unload the materials in S/S container.
• Use gloves elbow size during loading and unloading of materials.
• Before loading of the materials, ensure that the inner and outer surface of the drum mixer is cleaned as per the standard procedure.
• During mixing operation attach the status label to the drum mixer specifying the name of the product, Batch no. Mfg Date., and Expiry Date along with the signature of the production pharmacist.
7.1 Use large elbow size gloves during loading and unloading of materials.
7.2 Before loading of the materials, ensure that the inner and outer surface of the Q mixer is cleaned as per the standard procedure.
7.3 During mixing operation attach the status label to the drum mixer specifying the name of the product, Batch no, Mfg Date., and Expiry Date along with the signature of the production pharmacist.
5. Quality Record(s)/Form(s)
The following Quality Records shall be generated and managed in accordance with the Procedure for Control of Company Quality Records
|Required Record||Form Reference No.|
|Batch Manufacturing Record|
|Equipment Cleaning Certificate|
|To Be Cleaned|
|Cleaned Ready For Use|
|Under Process / Identification Slip|
|Machine History Card|