SOP FOR CLEANING & OPERATION PROCEDURE FOR COLLOID MILL (GELATIN MFG. AREA)

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 gelatin 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 color solution 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  Label the machine with clean equipment tag duly filled in.
5.1.9 Get it verified by Q.A. Executive.

      5.1.10   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 color solution using adjusting screws.

      5.2.10    After mixing is completed repeat the above process if required getting uniform               consistency of The color solution

      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.

Bhanu Pratap Singh

BHANU PRATAP SINGH IS EXPERIENCED IN PHARMACEUTICAL, AUTHOR AND FOUNDER OF PHARMACEUTICAL GUIDESLINE (WWW.PHARMAGUIDESLINE.COM), A WIDELY READ PHARMACEUTICAL BLOG SINCE 2019. EMAIL:- INFO@PHARMAGUIDESLINE.COM

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