GMP & Pharmaceutical Manufacturing Expert
â Reviewed by: Pankaj Sharma - Quality Control Specialist
Reviewed for Quality Control accuracy, laboratory practices, analytical methods, and technical relevance
đ Last Updated: April 3, 2023
1.0 Objective: To lay down a procedure for the operation of Bin Blender.
2.0 Scope: This standard operating procedure Operation of Bin Blender is applicable to the Bin Blender located in the manufacturing area.
3.0 Responsibility: Officer, Executive â Production Department follow procedure while executing the operation
Manager â Production Department for overall compliance

4.0 Procedure for Operation of Bin Blender:
4.1 Ensure the âCLEANEDâ label duly filled and signed is affixed on the equipment. Ensure cleanliness of equipment and area. Remove the âCLEANEDâ label and affix it to the respective BMR. Affix the “UNDER PROCESS” label duly filled and signed on the equipment and record all the observations in the Equipment Usage Log Sheet as per “Making entry in Equipment Log Book” SOP.
4.2 Turn âONâ the control âON/OFFâ key. The opening screen shall appear within one minute with the date and time displaying on the top LHS and RHS corners respectively.
4.3 Touch âLoginâ on the screen. Keypad will appear on screen. To open the digit keypad touch â0-9â. Load the correct password and then touch âEnterâ for confirmation.
Note: Three access levels have been provided in the machine.
Level 3 is meant for recipe editing.
Levels 2 and 1 are for machine operation in auto and manual modes.
4.4 Recipe Edition for Operation of Bin Blender:
4.4.1 Access level 3. Touch âRecipe Editâ on the screen. âRecipe Edit â 1â screen will appear with the following process parameters âProduct Name, Batch No., Operator Name, Mfg. Date, Exp. Date, Batch sizeâ.
4.4.2 Load the Product Name, Batch No., Mfg. Date, Exp. Date, Batch size as per respective BMR.
4.4.3 Touch âRecipe Editâ on the screen. The âRecipe Edit â 2â screen will appear with the following process parameters âBunker Capacity, Pre-Lubrication Time, Blender RPM, Print Intervalâ.
4.4.4 Load the Bunker Capacity, Pre-Lubrication Time, and Print Interval as per respective BMR.
NOTE: Blender RPM is fixed.
4.4.5 Touch âNextâ on the screen. Loaded process parameters shall be displayed on the screen.
4.4.6 Touch âRecipe Saveâ on the screen to save the recipe. Keypad will appear on screen. Give a suitable name to the recipe and then touch âEnterâ. The previous screen will appear. To delete any of the already existing recipes touch âRecipe Deleteâ on the screen. A stored recipe list will appear on screen. Select the recipe. Warning message âDelete Recipeâ will appear on screen. Touch âYesâ to delete.
4.4.7 Touch âExitâ on the screen. An opening screen will appear.
4.4.8 To select an already loaded recipe, touch Load recipe on the screen. A stored recipe list will appear on screen. Touch the recipe as per respective BMR the touch âEscapeâ. The selected stored recipe will be loaded.
4.5 Auto Mode Operation:
4.5.1 Touch âAuto modeâ on the opening screen with Operation details as âPre-Lubrication Cycleâ. Auto mode main screen will appear with the instruction âUnlock The Safety Railing And Open The Doorâ.
4.5.2 Touch âOFFâ to turn the âONâ auto mode operational.
4.5.3 Unlock the safety railing and touch âOK. Instruction âInsert The Bunkerâ will display on the screen.
4.5.4 Insert the bunker and lock it firmly. Touch âOKâ. Instruction âClose The Door And Lock The Safety Railingâ will display on the screen.
4.5.5 Close the safety railing such that it will press the railing limit switch. Touch âOKâ. Instruction âLift the Bunkerâ will display on the screen.
4.5.6 Touch âOKâ. Blender bin will start lifting upward and stop automatically at the middle limit switch. Instruction âUnlock The Safety Railing And Remove The Trolleyâ will display on the screen.
4.5.7 Unlock the safety railing and remove the trolley. Touch âOKâ on the screen. Instruction âLock The Safety Railingâ will display on the screen.
4.5.8 Lock the safety railing. Touch âOKâ. Instruction âStart The Cycleâ will display on the screen. Touch âOKâ. Next screen will display the set and actual blending RPM and Time.
4.5.9 Touch âStartâ on the screen. Cycle will start as per set parameters and stops automatically after set blending time. Next screen will show operation details as âPre-Lubrication Cycle Finishedâ and instruction âUnlock The Safety Railing and Insert The Trolleyâ.
4.5.10 Unlock the railing and adjust the trolley below the lifted blender bin. Touch âOKâ. Instruction âAdjust The Trolley And Lower The Bunkerâ will display on the screen.
4.5.11 Touch and hold âDownâ on screen. The blender bin will start lifting down. Touch âUpâ key to lifting up the blender bin, if required.
4.5.12 Screen will display operation details âLubrication Cycleâ and instruction âUnlock The Safety Railing And Open The Doorâ.
4.5.13 Unlock the safety railing and touch âOK. Instruction âAdd The Lubricantâ will display on the screen.
4.5.14 Open the lid of the blender bin and add the lubricant with S.S. scoop and firmly close the lid. âOK. Instruction âInsert The Bunkerâ will display on the screen.
4.5.15 Insert the bunker and lock it firmly. Touch âOKâ. Instruction âClose The Door And Lock The Safety Railingâ will display on the screen.
4.5.16 Close the safety railing such that it will press the railing limit switch. Touch âOKâ. Instruction âLift the Bunkerâ will display on the screen.
4.5.17 Touch âOKâ. Blender bin will start lifting upward and stop automatically at the middle limit switch. Instruction âUnlock The Safety Railing And Remove The Trolleyâ will display on the screen.
4.5.18 Unlock the safety railing and remove the trolley. Touch âOKâ on the screen. Instruction âLock The Safety Railingâ will display on the screen.
4.5.19 Lock the safety railing. Touch âOKâ. Instruction âStart The Cycleâ will display on the screen. Touch âOKâ. The next screen will display the set and actual blending RPM and Time.
4.5.20 Touch âStartâ on the screen. The cycle will start as per set parameters and stops automatically after set blending time. Next screen will show operation details as âPre-Lubrication Cycle Finishedâ and instruction âUnlock The Safety Railing and Insert The Trolleyâ.
4.5.21 Unlock the railing and adjust the trolley below the lifted blender bin. Touch âOKâ. Instruction âAdjust The Trolley And Lower The Bunkerâ will display on the screen.
4.5.22 Touch and hold âDownâ on screen. The blender bin will start lifting down. Touch âUpâ key to lifting up the blender bin, if required.
4.5.23 Screen will display operation details âLubrication Cycleâ and instruction âUnlock The Safety Railing And Open The Doorâ will display on the screen.
4.5.24 Unlock the safety railing. Touch âOKâ. Instruction âRemove The Bunkerâ will display on the screen.
4.5.25 Remove the blender bin. Touch âOKâ. Instruction âClose The Safety Railing And Lock The Doorâ will display on the screen.
4.5.26 Close the safety railing. Touch âOKâ. Opening screen will appear.
4.6 Manual Mode Operation and Unloading:
4.6.1 Touch âManual Modeâ on the opening screen. Manual mode main screen will appear.
4.6.2 Touch âOFFâ to turn âONâ manual mode operational.
4.6.3 Load the Blending time and RPM as per respective BMR.
4.6.4 Open the safety railing and insert the bunker and close the safety railing.
4.6.5 Touch and hold the âCage Upâ. Blender bin starts lifting upward. When the blender bin will reach the middle limit switch release the cage-up key.
4.6.6 Open the safety railing and remove the trolley and again close the safety railing.
4.6.7 Touch the âStartâ key to start the operation.
4.6.8 Actual time and RPM will display on the screen.
4.6.9 Operation will stop after a set time.
4.6.10 Touch and hold âBypassâ. The blender bin will start lifting up and stop at the upper limit switch.
4.6.11 Open the safety railing and place IPC below the outlet chute of the blending bin. Open the butterfly valve and unload the bin.
4.6.12 On completion of operation open the safety railing and insert the trolley and again close the safety railing.
4.6.13 Touch âCage Downâ on the screen. Blender bin will start lifting down. Touch âCage Upâ, if required.
4.6.14 Open the safety railing and remove the blender bin. Close the safety railing.
4.6.15 Touch âMainâ on the screen. An opening screen will appear.
4.7 Touch âLog Outâ. âYou Are Logged Outâ. Turn âOFFâ the control key.
4.8 Take the blender bin to the âGranules Storeâ area, if not unloaded.
4.9 Affix âTO BE CLEANEDâ label duly filled and signed on the bin blender.
4.10 Affix âTO BE CLEANEDâ labels duly filled and signed on blender bin if unloaded.
4.11 Record all the observations in the equipment Usage Log Sheet.
5.0 Abbreviations for Operation of Bin Blender:
BMR: Batch Manufacturing Record
IPC: In-process container
QA: Quality Assurance
SOP: Standard Operating Procedure.

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