by OBJECTIVE
To describe the procedure for cleaning and operation of colloid mill.
2.0 SCOPE
This SOP is applicable for cleaning procedure of colloid mill for Medicament manufacturing area.
3.0 RESPONSIBILITY
Production Chemist & operator : To follow the procedure
4.0 ACCOUNTABILTY:
QA & Head Production : For system compliance
| PROCEDURE | ||
| 5.1 | Cleaning: | |
| 5.1.1 | Ensure that Medicament is completely unloaded from the Colloid Mill. | |
| 5.1.2 | Carefully remove the hopper assembly by unscrewing the respective nuts to washing area. | |
| 5.1.3 | Wipe & clean the SS rotar and other parts with 2% Teepol solution using nylon brush. | |
| 5.1.4 | Pass excess water to remove last traces of Teepol. | |
| 5.1.5 | Finally rinse them with Purified water and air dry them. | |
| 5.1.6 | Wipe & clean the main body with damp cloth impregnated with 2% Teepol solution. | |
| 5.1.7 | Finally wipe clean them with dry lint free cloth. | |
| 5.1.8 | Send rinse water to QC for analysis | |
| 5.1.9 | Label the machine with clean equipment tag duly filled in. | |
5.1.10 Get it verified by Q.A. Executive.
5.1.11 Cleaning record entries in respective log book.
5.2 PROCEDURE
5.2.1 Check & ensure that colloid mill is cleaned properly.
5.2.3 Take the line clearance from IPQA as per “Line Clearance” SOP and enter the details in BPCR.
5.2.4 Affix the status label on the Colloidal mill.
5.2.5 Fix the SS rotor adjusting the slit and hopper assembly carefully.
5.2.6 Transfer the materials to be grinded in the hopper.
5.2.7 Switch ON the colloid mill.
5.2.8 Adjust the clearance of slit aperture by adjusting screws
5.2.9 Regulate the mixing and flow of medicament solution using adjusting screws.
5.2.10 After mixing is completed repeat the above process if required getting uniform consistency of medicament.
5.2.11 Enter the operation details in respective log book.
6.0 TRAINING
Trainer : Head Production Department
Trainees : Staff and machine operator of production and QA chemist.
7.0 DISTRIBUTION
Master Copy : QA Department
Controlled Copy : Production Department
Display Copy : Production Department (If Required)
8.0 ATTACHMENTS
Nil
- REFERENCES
In-house
10.0 ABBREVIATION
| Abbreviation | Extended Form |
| EG | Engineering |
| SOP | Standard Operating Procedure |
| QA | Quality Assurance |
| WH | Warehouse |
| NA | Not Applicable |
| MB | Microbiology |
11.0 REVISION HISTORY OF CHANGE
| Sr. No. | Date | Revision Details | Revision No. |
| 1 | 21/01/2020 | New SOP | 00 |
