SOP FOR OPERATION AND CLEANING OF GELATIN MASS COLOUR MIXER

1. 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