SOP FOR CLEANING PROCEDURE FOR GELATIN MASS REACTOR VESSELS

       1.0      OBJECTIVE

            To describe the procedure for Cleaning of gelatin mass reactor vessels.

2.0       SCOPE

This SOP is applicable for cleaning procedure of gelatin mass reactor vessel installed in gelatin manufacturing area.

3.0       RESPONSIBILITY

            Production Chemist & operator: To follow the procedure

4.0       ACCOUNTABILTY:

       Head Production & QA                  : For system compliance

5.0       PROCEDURE

5.1          Check and ensure that main electrical switch of Gelatin Mass preparation Reactor is off.

        5.2          Affix the status label “UNDER CLEANING” to the Gelatin Mass preparation Reactor dully filled and Signed by competent technical staff.

       5.3          Open the lid of Gelatin Mass preparation Reactor.

       5.4          Check and ensure that there is no gelatin mass in Gelatin Mass preparation Reactor of previous batch / product.

        5.5         Check and ensure that bottom valve of Gelatin Mass preparation Reactor is closed.

       5.6         Fill the hot water in Gelatin Mass preparation Reactor till the traces of gelatin mass.

                     Switch “ON” the main.

       5.7         Start the stirring of Gelatin Mass preparation Reactor at 20-30 RPM. 

       5.8         Start the heating at 80 °C± 5 °C of Gelatin Mass preparation Reactor and maintain it at least for 1hours.

       5.9        After stirring, switch off the Reactor and drain the water by opening the bottom valve of the Gelatin Mass preparation Reactor. 

      5.10       Check and ensure that there is no traces of gelatin mass if it is so then repeat the process unless the Completely removal of gelatin mass traces.        

      5.11       Wash the Gelatin Mass preparation Reactor with purified water.

  •        Finally rinse the Gelatin Mass preparation Reactor with sufficient quantity of purified water.

5.13       Send the sample to Quality Control for wash water analysis through in process Quality Assurance.

      5.14       Clean the outer surface with hot water and then mop it with lint free cloth.       

        5.15      Affix the status label “CLEANED” to the Gelatin Mass Preparation Reactor dully filled and signed by competent staff.

  5.16    Record the cleaning maintain in respective log book. 

5.0       TRAINING

Trainer   : Head Production

            Trainees : Staff and machine operator of the gelatin section and QA chemist.

6.0.                  DISTRIBUTION

Master Copy                      :            QA Department

Controlled Copy                :           Production Department

Display Copy                     :           Production Department

  • ATTACHMENTS

      Nil

      9.0      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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