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SOP for Saizoner Mixer Granulator


Standard operating procedure of Saizoner Mixer Granulator used in granulation process of tablets.

1.0  PURPOSE

       To laydown the procedure for Saizoner Mixer Granulator.

2.0  SCOPE

       This procedure is applicable to the cleaning and operation of Saizoner mixer granulator, Capacity 600 ltr.

3.0  RESPONSIBILITY

       Operator/ Officer Production
       Executive Quality Assurance

4.0  ACCOUNTIBILITY

       Head Production

5.0  PROCEDURE


5.1  Cleaning procedure for product changeover:


5.1.1  Switch OFF the mains.

5.1.2  Ensure that `To be Cleaned’ label is put on the equipment.

5.1.3  Ensure that the purging air is ‘ON’ during the entire washing cycle.

5.1.4  Remove all adhered material from the bowl using scrapper.

5.1.5  Fill the bowl with potable water 75 liters. Add 75 ml 2% of nonionic detergent solution.

5.1.6  Close the lid. Put `ON’ the mains and run the agitator blade and chopper blade at fast speed for 2-3 minutes. Switch OFF the machine.

5.1.7  Open the discharge valve and drain the washing.

5.1.8  Open the lid and ensure all loose materials are washed out.

5.1.9  Repeat the steps 5.1.5 to 5.1.7.

5.1.10  Dismantle the agitator blade, chopper blade assembly, vent port, binder addition port and spray ball and clean with 1 liter. of 2% non ionic detergent solution using nylon scrubber.

5.1.11  Open the cover of discharge port and clean the inside, lid and seal with 80 liters. Potable water followed by 1 liter of 2% nonionic detergent solution using nylon scrubber. 

5.1.12  Rinse all these parts using 80 liters potable water to remove the detergent.

5.1.13  Finally, rinse all above parts with 100 liters purified water.

5.1.14  Wash all the external surfaces and wipe dry using dry duster.

5.1.15  Visually ensure the cleanliness of the machine

5.1.16  Intimate QA dept. to collect the wash water sample and wait for the approval.

5.1.17  On receipt of QA clearance dry all the parts using filtered compressed air/ hot air blower.

5.1.18  Remove `To be Cleaned’ label and affix duly signed `Cleaned’ label

5.1.19  Assemble the SMG.

Note: The cleaning of the clean equipment remains valid for 48 hours, if the equipment is not used within 48 hours, then it should be re-cleaned as per the procedure mentioned above from step 5.1.12.

5.2  Cleaning procedure for batch-to-batch changeover:

5.2.1  Switch `OFF’ the mains.

5.2.2  Remove all adhered material from the bowl using a scrapper.

5.2.3  Wipe external surface with clean moist duster followed by clean dry duster.

Related: SOP for Product Changeover


5.3  Operating procedure:

5.3.1  Checks and precautions:

5.3.1.1  Wear hand gloves, over coat and nose mask during the operation.

5.3.1.2  Ensure that chopper blade and agitator blade rotates in opposite direction.

5.3.1.3  Ensure that incoming air pressure is not less than 4 kg/sq. cm.

5.3.1.4  Ensure that all safety interlocks are in operation.

5.3.1.5  Ensure that FBD/FBP product container is placed below the discharge valve.

5.3.2  Procedure:

5.3.2.1  Remove `Cleaned’ label from the equipment and affix in BMR.

5.3.2.2  Affix `Under process’ stage label on the equipment.

5.3.2.3  Charge all sifted raw material as per the BMR using material transfer system as per SOP.

5.3.2.4  Select operation mode as Manual / Auto mode.

5.3.2.5  In Manual mode operation follow the instructions as mentioned in BMR.

5.3.2.6  In Auto mode recall product recipe from PLC and follow the set parameters, if applicable.

5.3.2.7  Dry mix the charged raw material for a time as mentioned in BMR at slow speed.

5.3.2.8  Add binder solution at the specified rate as mentioned in BMR.

5.3.2.9  Continue the granulation procedure as mentioned in BMR.

5.3.2.10  On achieving the end point, note down the ampere reading

5.3.2.11  Open the discharge valve in manual mode (for both manual / Auto mode)

5.3.2.12  Start the SMG at 1 rpm and co mill simultaneously.

5.3.2.13  Operate the Co-mill as per SOP for Co-mill.

5.3.2.14  Collect the milled wet granulated material in FBD/FBP product container.

5.3.2.15  Switch `OFF’ the SMG, Co-mill.

5.3.2.16  Open the lid of SMG and scrap off any adhered material.

5.3.2.17  Remove `Under process’ label.
6.0  ABBREVIATIONS

6.1  SMG: Saizoner Mixer Granulator
6.2  SOP: Standard Operating Procedure
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
Email: .moc.enilediugamrahp@ofni Need Help: Ask Question


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