OBJECTIVE:
To lay down a Procedure for Operation of Comill (Make Bactochem).
SCOPE:
The scope of this SOP is Procedure for the operation of Comill.
RESPONSIBILITY:
Initiator Officer/Designee: Production shall perform the operation activity as per SOP.
Initiator Executive/Designee: Production shall ensure the compliance of the SOP
ACCOUNTABILITY:
QA Head shall be Accountable for implementation of SOP.
ABOUT COMILL
The term “COMILL” commonly refers to a “conical mill,” a piece of machinery crucial in various industries, particularly pharmaceuticals, food processing, and chemicals. These mills are designed for size reduction, de-agglomeration, and consistent particle sizing of materials. A conical mill utilizes a rotating impeller and a conical screen to process substances, ensuring uniformity. They are valued for their ability to achieve precise particle size distributions, which is essential for product consistency and quality. Key features include their adaptability to both wet and dry materials, and their ability to minimize dust and heat generation during processing.
PROCEDURE:
Check the cleanliness of the area and the machine.
Remove the “CLEANED” label and affix the “UNDER PROCESS” label to the Co mill.
Check the room temperature and relative humidity.
Use cleaned scoops during the milling operation.
Check the required quantity of all the materials to be milled as per BMR.
SET-UP: Fixing of the Impeller and Screen:
Check the integrity of the impeller and screen.
Check the screen of the desired size.Check the integrity of the gaskets.
Assemble the impeller and screen.
Secure the impeller assembly with retaining pins and mount the impeller in position by tightening the bolts.
Mount the desired screen on the screen holding plate and mount the holding plate on the two studs.
Lock by rotating and clamp with wing nuts.
Check the alignment of screen on the holding plate; do not force the screen-holding plate on the studs.
Mount the discharge shroud.
Operation:
Insert the power plug into the power supply socket and switch ON the mains.
Switch ON the main switch on the operating panel.
Press Co mill ON button on the operating panel.
Check that the machine is working properly.
Press Co mill OFF button on the operating panel.
Place the collection bin / container below the discharge shroud.
Press Co mill ON button on the operating panel.
Rotate the Pot knob and set the desired speed.
Charge the material gradually into the feed chute.
Feed the material at constant rate.
Collect the milled material into container and label accordingly.
After completion of the milling operation press Comill OFF button on the operating panel.
Switch OFF the main switch on the operating panel.
After ensuring that the machine is stopped, remove the screen and check for the integrity.
Affix “TO BE CLEANED” label after the completion of milling operation.
NOTE:
Do not overfeed the equipment as it may jam the impeller and damage the screen.
Do not operate the equipment without a screen, screen holding plate and discharge shroud in position.
Wait for the machine to stop fully.
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REFERENCES:
Not Applicable
ANNEXURES:
Not Applicable
ENCLOSURES: SOP Training Record.
DISTRIBUTION:
Controlled Copy No. 01 : Head Quality Assurance
Controlled Copy No. 02 : Head Production
Master Copy : Quality Assurance Department
ABBREVIATIONS:
| PD | : | Production |
| No. | : | Number |
| SOP | : | Standard Operating Procedure |
| QA | : | Quality Assurance |
REVISION HISTORY:
CHANGE HISTORY LOG
| Revision No. | Details of Changes | Reason for Change | Effective Date |
| 00 | New SOP | Not Applicable | To Be Written Manual |
Click the link to download word file copy of this document:
https://pharmaguidehub.com/product/operation-of-comill/