SOPs

SOP for Operating Procedure for Gelatin Storage Vessel

SOP for Operating Procedure for Gelatin Storage Vessel

Check the ‘CLEANED’ status label duly filled and signed on the Gelatin Storage Vessel,

then unwrap the cling film.

Ensure the cleanliness of the Gelatin Storage Vessel.

Affix ‘BATCH IN-PROCESS’ status label on Gelatin Storage Vessel duly filled and signed.

Record all observations in line clearance record.

Fill the potable water in the jacket of the Gelatin Storage Vessel.

Put the preheated Gelatin Storage Vessel below the Gelatin Melting Reactor and

open the bottom valve of the Gelatin Melting Reactor manually and transfer

the gelatin mass as required.

Put the Gelatin Storage Vessel nearest to the electric panel.

Connect the temperature sensor and heater sockets with a respected plug

available in the control panel.

Press the ‘ON/OFF’ switch to power up the control panel.

Set the required temperature in the digital temperature indicator and

controller by increasing or decreasing the button of the digital temperature

indicator and controller.

Take the Gelatin Storage Vessel to the Colour Mixer Assembly.

Switch ‘ON’ the main power supply of the Colour Mixer Assembly.

Switch ‘ON’ the hydraulic motor of the Colour Mixer Assembly and press

the switch to lift up the head of the Colour Mixer Assembly.

Install the Gelatin Storage Vessel beneath the head of the Colour Mixer Assembly.

Fix the stirrer of Colour Mixer Assembly manually.

Press the switch to bring down the head of the Colour Mixer Assembly.

Tight all nuts with the Gelatin Storage Vessel.

Start the stirrer of Colour Mixer Assembly by pushing the ‘ON’ button.

Do the vacuum in the Gelatin Storage Vessel ( if required ) starting the vacuum

pump by pushing the vacuum ‘ON/OFF’ switch provided gelatin panel.

Before starting the vacuum pump do the following:

Close all the manual valves of the top head and blind any open connection.

Start the potable water supply to the vacuum pump.

Open the vacuum line valve on the Gelatin Storage Vessel.

Start the heater to heat the water in the jacket of the Gelatin Storage Vessel as required.

After completion of Mixer and de-aeration :

Shut off the vacuum pump and break the vacuum in the Gelatin Storage

Vessel by opening the vacuum break valve.

Stop the stirrer by pushing the stop button.

Stop the heater.

Loose all the nuts of the body flange and take the head up by pressing the hydraulic switch.

Remove the Gelatin Storage Vessel having gelatin mass and take it to the designated area.

Connect the temperature sensor and heater sockets with a respected plug

available in the control panel.

Press the ‘ON/OFF’ switch to power up the control panel.

Set the required temperature in the digital temperature indicator and controller

by increasing or decreasing the button of the digital temperature indicator and controller.

Switch on the heater of the Gelatin Storage Vessel.

Set the temperature as per the respective product BMR.

Gelatin Storage Vessel is charged into the Encapsulating Machine by opening

the flush bottom valve manually.

After completion of the process Affix the ‘TO BE CLEANED’ label on the Gelatin Storage

Vessel duly filled and signed.

Record the activities in Machine Log Sheet.

NOTE: The personnel working on Gelatin Storage Vessel shall wear protective aids

i.e. Eye Goggles, Mask if required, and Surgical hand gloves in addition to the

normal gowning of the secondary area.

ABHA

Abha is the Author  of pharmaceutical guidance, she is a pharmaceutical professional having more than 22 years of rich experience in pharmaceutical field. During her career, she works in the quality assurance department with multinational companies i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd. During his experience, she faces many regulatorily audits i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda, Kenya, Tanzania, Zimbabwe. She is currently leading a regulatory pharmaceutical company as a Head Quality. You can join him by Email, Facebook, Google+, Twitter, and YouTube