by - OBJECTIVE:
To lay down a Procedure for Operation and Cleaning of Gelatin Mass Colour Mixer.
- SCOPE:
This SOP is applicable to Operation and Cleaning of Gelatin Mass Colour Mixer used in Soft Gelatin Capsule Section.
- RESPONSIBILITY:
Officer / Executive – Production: To follow the SOP.
- ACCOUNTABILITY:
Head – Production: Effective Implementation of SOP.
- PROCEDURE:
- OPERATION:
- Check & ensure that colour mixer is cleaned properly.
- Take the line clearance from QA as per “Line Clearance” SOP and enter the details in BPCR.
- Affix the status label on the colour mixer.
- Lift the colour mixer manually.
- Take the gelatin mass tank having gel mass under the colour mixer.
- Add the colour solution to gel mass.
- Switch “ON” the colour mixer and start the mixing.
- After completion of the mixing switch “OFF” the colour mixer.
- Enter the operation details in “Machine Utilization Record”
- CLEANING:
- Ensure that mains switch is “OFF”.
- Wash the colour mixer with potable water and below collect the wash water in a container and drain it to washing area.
- Wash the colour mixer using 2 % v/v Teepol solution with the help of scrubber and below collect the wash water in a container and drain it to the washing area.
- Finally wash the colour mixer with purified water and drain it to the washing area.
- Dry the colour mixer using dry lint free cloth.
- Mop the colour mixer with 70% v/v IPA solution.
- Affix a label as “Cleaned”.
Enter the cleaning details in “Machine Utilization Record”.
- TRAINING
Trainer : Head – Production Department
Trainees : Staff and machine operator of production and QA chemist.
DISTRIBUTION
Master Copy : QA Department
Controlled Copy : Production Department
Display Copy : Production Department (If Required)
ATTACHMENTS
Nil
- REFERENCES
In-house
ABBREVIATION
| Abbreviation | Extended Form |
| EG | Engineering |
| SOP | Standard Operating Procedure |
| QA | Quality Assurance |
| WH | Warehouse |
| NA | Not Applicable |
| MB | Microbiology |
REVISION HISTORY OF CHANGE
| Sr. No. | Date | Revision Details | Revision No. |
| 1 | NA | New SOP | 00 |
