OBJECTIVE
To lay down a procedure for operation of octagonal blender.
SCOPE
This procedure applies for production department in Pharmaceutical Manufacturing Facilities Formulation division.
RESPONSIBILITY
The operator is responsible for implementation of the process.
The Production In-Charge is responsible for the execution of the procedure.
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PROCEDURE
- Check the cleanliness of Octagonal Blender.
- Fix the Baffles in center position of Octagonal Blender.
- Fix cover plate at the top apex of blender with help of wing nuts.
- Keep the product container on hydraulic trolley and load the product in it.
- Raise the hydraulic trolley till mouth of bulk container touches to conical cover which is attached to discharge valve.
- Clamp bulk container with ‘U’ clamp to conical cover and put lock in the ‘U’ clamp.
- Now put down pipe guard or safety guard and switch ‘ON’ the machine.
- Initially run the blender on inching switch, check the smooth running of blender and then put it ‘ON’ switch.
- When bulk container reaches to Top position of blender, switch ‘OFF’ and open the butterfly valve with help of hand wheel.
- Keep it open for 1-2 minutes. Shake butterfly valve and lock it.
- Again switch ‘ON’ the blender and take bulk container in down position. Switch ‘OFF’ the blender.
- Keep hydraulic trolley below the bulk container and unclamp the lock and remove bulk container.
- Again load the product in bulk container and repeat the procedure till all products is loaded.
- Set the time this is given in Batch Manufacturing Record on timer switch and switch ‘ON’ the blender.
- When required time is over, blender will stop automatically.
- Take discharge valve down position and keep bulk container below the valve raise the hydraulic trolley to minimize the distance between conical cover and bulk container.
- Open the butterfly valve slowly with help of hand wheel and collect product in product container.
- Again lock the butterfly valve and remove bulk container and load the product in another container and again keep product container below the valve and repeat the procedure.
- Empty out the complete product from blender and weigh the OFF loaded product.
- After stopping blender, every time raise the pipe guard or safety guard in ‘up’ position, and lock it and before starting blender take guard in ‘down’ position and then switch ‘ON’ the blender.
- All the operation details shall be entered in the equipment usage logbook.
ABBREVIATION(s)
Q.A - Quality Assurance
BL - Beta-Lactam
SOP - Standard Operating Procedure
No. - Number
P.D - Production
B.M.R - Batch manufacturing record
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