SOP FOR CLEANING OF GELATIN MASS RECEIVER TANK AND SUPPLY PIPE

OBJECTIVE

To describe the procedures for cleaning of gelatin mass receiver tank and supply pipe.

2.0       SCOPE

This SOP is applicable for cleaning procedures of gelatin mass receiver tank and supply pipe.

3.0       RESPONSIBILITY

            Production Chemist & operator      : To follow the procedure

4.0       ACCOUNTABILTY:

       QA & Head Production                  : For system compliance

5.0       PROCEDURE

           Check “TO BE CLEANED” label on gelatin receiver tank.

            Switch off the mains power supply to the gelatin receiver tank & supply pipes.

            Ensure that the gelatin receiver tank is completely empty.

              Bring the receiver tank to the cleaning area and Dismantle the gelatin mass holding tank & also

                   the supply pipe which are attached together with the help of clamp. Fill the receiver tank with hot water for 30 minutes. And continue scrub with nylon brush for 5 minutes after drain water. 

            Take the teepol solution 2% for mopping as inner & outer surface.

            Open the bottom drain valve to drain out water.

            Fill the receiver tank with tab water and stir for 5 minutes then after drain the water.

            Check the receiver tank for traces of gelatin mass. If no traces of gelatin mass found.

            Final rinse the receiver tank with purified water.

  •     Remove the drain valve check the cleanness of the valve. If required clean it using hot water.
    •     Clean the outer surface of receiver tank with wet cloth.

        Scrub parts of the holding tank and lid with nylon brush and mop with clean lint free cloth 

    Using.  Take most care while cleaning the ‘Hard to clean area’ i.e. joints, corners, pipe bents etc.

  •      Intimate Quality Assurance (Q.A.) for taking wash out sample.
    •      Finally mopping inner surface with lint free cloth. 
    •      Upon getting clearance for wash out report and  take out the parts by wearing gloves     and cover it with cling film and affix the label “CLEANED” (READY FOR INSPECTION) on the gelatin receiver tank and keep them in equipment hold area or take back to the gelatin area as and when required.
  •      Intimate to Q.A. for line clearance of gelatin mass holding tanks and supply pipe.
    •      After release from Q. A. affix “READY FOR USE” label on the gelatin receiver tank.
    •       If there is no planning of production for a longer time, rinse the gelatin receiver tank with Purified water before starting the operation.

        Before using, mop with 70% IPA solution.

     6.0        TRAINING

Trainer   : Head Production

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

    7.0.        DISTRIBUTION

Master Copy                      :            QA Department

Controlled Copy                            :            Production Department  

Display Copy                     :           Production Department

 8.0        ATTACHMENTS

Sr. No. Annexure No. Title Format No.
  •        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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