1.0 OBJECTIVE
- To lay down a procedure for the operation of Multimill.
2.0 RESPONSIBILITY
- Technical Assistant – To follow the SOP.
- Executive – To comply the SOP.
3.0 PROCEDURE
3.1 Check the cleanliness of the area and the machine.
3.2 Use cleaned scoops during the milling operation.
3.3 Get line clearance from QA department before starting the operation.
3.4 Remove the “CLEANED” label and affix the “UNDER PROCESS” label to the multimill.
3.5 Procure all the materials of required quantity as per the BPRR to be milled in the milling area.
NOTE: Use the screen as specified in the BPRR of that product.
3.6 SET-UP:
3.6.1 FIXING OF ROTOR AND BLADES ASSEMBLY
3.6.1.1 Ensure that blades are fixed in the rotor are in sequence.
3.6.1.2 Ensure that blades are fixed with their knife-edge in forward direction.
3.6.1.3 Ensure that all blades are secured with retaining pins.
3.6.1.4 Align the rotor with blades to the drive shaft.
3.6.1.5 Fix the rotor with blades to the drive shaft with help of bolt.
3.6.1.6 Tight the bolt with help of spanner.
3.6.2 FIXING OF SCREEN:
3.6.2.1 Check the screen physically for its integrity.
3.6.2.2 Align the screen on the base plate (Base plate has got circular groove to place the screen).
CAUTION: Do not force screen holding plate on studs.
3.6.2.3 Fix the screen holding plate along with the screen on the two studs.
3.6.2.4 Tighten the two studs.
3.6.2.5 Close the slide valve by pushing inside.
3.6.2.6 Check that knives of the rotor are not touching the screen by turning the belt by hand / by inching.
3.6.3 FIXING OF DISCHARGE HOPPER
3.6.3.1 Check that gasket is properly positioned.
3.6.3.2. Align the hopper with mounting bracket.
3.6.3.3 Fix the hopper with the help of four Ring nuts.
3.6.3.4 Tighten the Ring nuts with help of adjustable spanner / screwdriver.
3.6.4 FIXING OF CHARGING HOPPER:
3.6.4.1 Check that gasket is in position.
3.6.4.2 Align the hopper with mounting bracket.
3.6.4.3 Fix the hopper with help of wing nuts.
3.6.5 OPERATION:
3.6.5.1 Put the power plug into the power supply socket. Switch on the mains.
3.6.5.2 Check that machine is working properly and Switch on/off the mains.
3.6.5.3 Place SS container/IPC below the product outlet chute and Connect with dust free Interface.
3.6.5.4 Attach one end of dust free interface to the discharge hopper of multi mill and the other end to the container/IPC mouth.
3.6.5.5 Transfer the material to be milled into IPC.
3.6.5.6 Lift the IPC with the help of the Material handling device (if material is in SS container/double lined polythene bag, add the material to be milled manually with the help of a SS scoop).
3.6.5.7 Position the IPC such that the discharge of IPC is on charging hopper of multi mill inter connected with dust free interface.
3.6.5.8 Switch on the mains. Turn the switch for direction on the drive in the Anti clock wise direction for ‘Reverse’ direction and turn in clock wise direction for ‘Forward’ direction. To increase or decrease the speed use potentio meter knob.
3.6.5.9 Feed the material at constant rate and regulate the input by adjusting the butterfly valve of the IPC and sliding lid of feeding hopper.
NOTE :Dust free Interface can be food grade silicon bellow or lint free cloth.
CAUTION:
1) Do not change the direction of rotation during the milling operation.
2) Wait for the machine to stop fully before changing the direction.
3) Over feeding may jam the rotor and blades that may damage the screen.
3.6.5.10 Collect the milled material into IPC container and label accordingly.
3.6.5.11 After completion of the milling operation, Press the red push button to stop the machine.
3.6.5.12 After ensuring that the machine is stopped, remove the screen and check its integrity.
3.6.5.13 Record the details of the operation in the BPRR.
3.6.5.14 Affix a “TO BE CLEANED” label after the completion of milling operation.
3.6.5.15 Record the operation of the machine in the Equipment Log book.
4.0 ABBREVATIONS
4.1 SS – Stainless steel.
4.2 BPRR – Batch Processing Record.
4.3 Q.A. – Quality assurance.
4.4 Q.C. – Quality control.
4.5 IPC – Inprocess Container
5. 0 REFERENCES
5.1 Nil
6. 0 ANNEXURES
6.1 Nil
7.0 Distribution
This SOP (Controlled Copy & Display copy) shall be distributed to Manufacturing department.
8.0 SOP Revision History record
| Revision No. | Details for Revision(s) with Change Control No. | Effective Date (Sign. / Date) |
Pharmaceutical Updates 