SOP FOR OPERATION OF GELATIN MASS PREPARATION REACTOR.

OBJECTIVE

            To describe the procedure for operation of gelatin mass preparation reactor.

2.0       SCOPE

This SOP is applicable for operation of gelatin mass preparation reactor installed in 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         Check the status label “CLEANED” onGelatin Mass preparation Reactor.

5.2         Take the line clearance approval from in process IPQA personal.

5.3         Switch “ON” the main electrical supply and Gelatin Mass Preparation Reactor.

5.4         Check and ensure that bottom valve of Gelatin Mass Preparation Reactor is closed.

5.5         Start hot water circulation pump to preheat the melter. Temperature for water inlet = 75^OC-85 ^OC).

5.6         Apply the vacuum 400-500 mmHG in to gelatin cooking vessel.

 5.7        Switch ON the stirrer and put the speed limit at (20-30 RPM).

5.8         Load the raw materials though pipe one by one to the Gelatin Mass preparation Reactor as per specified in Respective batch manufacturing record about 120 Minutes.

5.9        Maintained the temperature in between (80^OC±5 ^OC) till the gets completely melted

5.10      Open the bottom valve and take the Gelatin Mass will be collected in Petri dish/ SS Plate and spread it throughout the plate and visually it will be checked for the absence of un-melted pieces of gelatin. 

5.11      if any un-melted pieces found, take out the sample after Avery 10 minutes to check the melting of gelatin mass.

5.13      Apply the vacuum (600-700 mmHG) to remove the entrapped air completely about to 35-45 minutes under steering of 20-30 RPM. 

5.14      After completion of the process unload the gelatin mass through opening the bottom valve in pre-heated gelatin mass holding tank temperature about (60^oC±5^oC).

5.15       Switch “OFF” the main electric supply and Gelatin Mass Preparation Reactor.

5.16       Affix the status label “TO BE CLEANED” to the Gelatin Mass Preparation Reactor duly filled and signed by competent technical staff.

•       Record the observations in respective log book.

    6.0      TRAINING

Trainer   : Head – Production Department

            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

    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.