SOP for Operating Procedure of Octagonal Blender

OBJECTIVE

To lay down a procedure for the operation of an octagonal blender.

SCOPE

This procedure applies for the production department in the Pharmaceutical Manufacturing Facilities Formulation division.

RESPONSIBILITY

The operator is responsible for the implementation of the process.

The Production In-Charge is responsible for the execution of the procedure.

PROCEDURE

• Check the cleanliness of the Octagonal Blender.
• Fix the Baffles in the center position of the Octagonal Blender.
• Fix the cover plate at the top apex of the blender with the help of wing nuts.
• Keep the product container on a hydraulic trolley and load the product in it.
• Raise the hydraulic trolley till the mouth of the bulk container touches to conical cover which is attached to the discharge valve.
• Clamp the bulk container with ‘U’ clamp to the conical cover and put the lock in the ‘U’ clamp.
• Now put down the pipe guard or safety guard and switch ‘ON’ the machine.
• Initially run the blender on the inching switch, check the smooth running of the blender and then put it ‘ON’ switch.
• When the bulk container reaches to Top position of the blender, switch ‘OFF’ and open the butterfly valve with the help of the hand wheel.
• Keep it open for 1-2 minutes. Shake the butterfly valve and lock it.
• Again switch ‘ON’ the blender and take the bulk container in the down position. Switch ‘OFF’ the blender.
• Keep the hydraulic trolley below the bulk container and unclamp the lock and remove the bulk container.
• Again load the product in a bulk container and repeat the procedure till all products are loaded.

• Set the time this is given in Batch Manufacturing Record on the timer switch and switch ‘ON’ the blender.
• When the required time is over, the blender will stop automatically.
• Take the discharge valve down position and keep the bulk container below the valve raise the hydraulic trolley to minimize the distance between the conical cover and the bulk container.
• Open the butterfly valve slowly with the help of a hand wheel and collect the product in the product container.
• Again lock the butterfly valve and remove the bulk container and load the product in another container and again keep the product container below the valve and repeat the procedure.
• Empty out the complete product from the blender and weigh the OFF-loaded product.
• After stopping the blender, everytime raise the pipe guard or safety guard in the ‘up’ position, and lock it before starting the blender take the guard in the ‘down’ position and then switch ‘ON’ the blender.
• All the operation details shall be entered in the equipment usage log book.

ABBREVIATION

Q.A - Quality Assurance

BL - Beta-Lactam

SOP - Standard Operating Procedure

No. - Number

P.D - Production

B.M.R - Batch manufacturing record

ANNEXURE

Nil

REVISION HISTORY

Nil

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