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SOP for Tippler


Standard operating procedure of Tippler in Pharmaceutical manufacturing.

1.0  Purpose: 

To lay down the procedure for cleaning and operation of Tippler.

2.0  Scope: 

This procedure is applicable to the cleaning and operation of Tippler of capacity 250 kg, Make: Tapasya Engineers.

3.0  Reference & Attachments:

3.1  References:
3.1.1.  In house.
3.2.  Attachments:
3.2.1.  Attachment –1. Sequential Logsheet

4.0  Responsibility:    

4.1.  Operator:

4.1.1.  To clean the tippler as per defined procedure.
4.1.2.  To operate the tippler as per defined procedure.

4.2.  Production:

4.2.1.  To check the cleaning and operation as per defined procedure.
4.2.2.  To maintain equipment sequential log.

4.3.  Quality Assurance:

4.3.1.  To ensure cleaning and operation as per defined procedure.
4.3.2.  To ensure maintenance of records.

5.0  Distribution:

5.1.  Manager Quality (Master copy).
5.2.  Manager Production
5.3.  Production Shop Floor (Display Copy)

6.0  Definitions of terms:

6.1.  FBD/ FBP: Fluid Bed Dryer/ Fluid Bed Processor.
6.2.  BMR: Batch Manufacturing Record.  

7.0  Cleaning 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.  Remove all adhered material if any from the tippler dome.
7.1.4.  Clean thoroughly using 30 liters. running potable water followed by 1 liter of 2% non-ionic detergent solution using nylon scrubber.
7.1.5.  Rinse with 60 liters water to remove the detergent.
7.1.6.  Finally wash the above part using 80 liters of running purified water.
7.1.7.  Clean all the external surface of the equipment body using moist duster followed by clean dry duster.
7.1.8.  Visually ensure the cleanliness of the equipment.
7.1.9.  Intimate QA dept. to collect wash water sample and wait for the approval.
7.1.10.  On receipt of QA approval, dry all the parts using filtered compressed air
7.1.11.  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 step 7.1.6.

7.2.  Cleaning procedure for batch to batch changeover:

7.2.1.  Ensure that mains are switched `OFF’.
7.2.2.  Remove all adhered material if any from tippler.
7.2.3.  Clean external surface of the tippler with clean moist duster followed by clean dry duster.
Note: The cleaning of the equipment remains valid for 48 hours. If the equipment is not used within 48 hours then it should be recleaned as per the Cleaning procedure for product changeover.

7.3.  Operating procedure:

7.3.1.  Checks and precautions:

7.3.1.1.  Wear hand gloves, overcoat and nose mask during the operation.
7.3.1.2.  Ensure that the discharge valve of the tippler is in `Close’ position.
7.3.1.3.  Ensure that the required screen is fitted inside the comminuting mill as per BMR.
7.3.1.4.  Ensure that the polybag lined container is kept below the discharge valve of the comminuting mill to collect the milled material.

7.3.2.  Procedure:

7.3.2.1.  Check that `Clean’ label is put on the equipment.
7.3.2.2.  Remove `Clean’ label and affix it in the BMR.
7.3.2.3.  Affix `Under process’ label on the equipment.
7.3.2.4.  Bring FBD/ FBP product container trolley below the tippler and align with tippler.
7.3.2.5.  Switch `ON’ the mains.
7.3.2.6.  Lower down the tippler so as to fit exactly on the top of the FBD/ FBP product container trolley.
7.3.2.7.  Clamp all the holdings to the FBD/ FBP product container.
7.3.2.8.  Lift the tippler along with FBD/ FBP product container to a height of about 450 mm
7.3.2.9.  Rotate the tippler 180° clockwise.
7.3.2.10.  Lift the tippler gradually and position it over the hopper of the comminuting mill.
7.3.2.11.  Switch `OFF’ the mains of tippler.
7.3.2.12.  Switch `ON’ the mains of comminuting mill.
7.3.2.13.  Set the screw feeder and beater RPM as required.
7.3.2.14.  Open the discharge valve of the tippler and control the feed rate from tippler to the comminuting mill as required.
7.3.2.15.  After completion of the operation close the discharge valve of the tippler.
7.3.2.16.  Switch `OFF’ the mains of comminuting mill and remove aside.
7.3.2.17.  Lower the tippler gradually to a height of about 450 mm above resting position and rotate the tippler 180° anticlockwise.
7.3.2.18.  Lower the tippler further so as to position the FBD/ FBP product container over its trolley.
7.3.2.19.  Remove the holding clamps and lift the tippler to the safe height.
7.3.2.20.  Remove the `Under process’ stage label and affix ‘To be cleaned’ label.
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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