OBJECTIVE:
To lay down a Procedure for operation of Colloidal mill.
SCOPE:
The scope of this SOP is procedure for operation of Colloidal mill.
RESPONSIBILITY:
Initiator Executive/Designee: Production shall ensure the compliance of the SOP
Initiator Officer/Designee: Production shall perform the operation activity as per SOP.
ACCOUNTABILITY:
QA Head shall be Accountable for implementation of SOP.
ABOUT COLLOIDAL MILL:
Colloidal mills are essential in pharmaceutical manufacturing for reducing particle size and creating stable dispersion. They work by subjecting materials to intense shearing forces between a rotor and stator, generating fine particles within the colloidal size range (1nm-1µm). This process is crucial for enhancing drug solubility, bioavailability, and uniformity in formulations like creams, ointments, and suspensions. In pharmaceuticals, colloidal mills ensure consistent drug delivery and improve product stability by preventing sedimentation or aggregation. Their precise control over particle size distribution makes them indispensable for producing high-quality, efficacious medications.
OPERATION:
Check for the cleanliness of the machine and area.
Line clearance shall be taken from IPQA executive before starting the operation as per SOP No. __.
Remove the “CLEANED” label and affix the “UNDER PROCESS” label to the machine.
Ensure that accessories attached to the colloidal mill are cleaned.
Check that the temperature and relative humidity are within the limits and maintained during the entire operation in the area.
Put the main switch to “ON” position.
Check the proper functioning of the machine, in case of any problem is observed, stop the Machine and inform engineering department by rising work order.
Do not proceed until the problem is rectified.
Rotate the knob to “ON” position to start the machine.
Put the solution to be milled into the hopper of the colloidal mill.
Ensure that the valve should be closed before pouring the solution in to the hopper.
Run the colloidal mill for the required time as per the BMR.
After completion of the cycle, collect the solution in a cleaned SS container by opening the valve.
After collecting the solution close the valve.
Repeat the cycle until all the solution to be milled is passed through the colloidal mill.
Rotate the knob to “OFF” position to stop the machine. Record the operation details s in the Equipment Logbook as per SOP.
Click the link to download word file copy of this document:
https://pharmaguidehub.com/product/operation-of-colloifal-mill/
REFERENCES:
Not Applicable
ANNEXURES:
Not Applicable
ENCLOSURES: SOP Training Record.
DISTRIBUTION:
Master Copy : Quality Assurance Department
Controlled Copy No. 01 : Head Quality Assurance
Controlled Copy No. 02 : Head Production
ABBREVIATIONS:
| HDPE | : | : High density polyethylene |
| SOP | : | Standard Operating Procedure |
| BMR | : | Batch Manufacturing Record |
| LHS | : | Left hand side |
| QA | : | Quality Assurance |
| RHS | : | Right hand side |
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-colloifal-mill/
