SOP for operation of Auto coater

SOP for operation of Auto coater

Standard Operating Procedure (SOP)

Objective

To lay down a procedure for operation of Auto coater.

Scope

This SOP is applicable for operation of Auto coater in the formulation plant.

Responsibility

Production Operator/ Technician – For operation of the machine.

Production Officer/Executive -To maintain proper functioning of the equipment & procedure.

Accountability

Head of Production shall be responsible for the compliance of SOP.

Procedure

Pre-start up:

Visually check the cleanliness of the room/ equipment and ensure that the area/ equipment are free from remains of previous product/ Batch.

Remove the “CLEANED” label from the machine.

Fix the “EQUIPMENT STATUS” label on machine.

Check the room temperature and relative humidity and record the observation. If environmental conditions are not found within the limit, inform the maintenance department for rectification and don’t proceed further, till it gets rectified.

Switch “ON” the mains of machine.

Check for water level in scrubber, if water level is found satisfactory, process further or else fill / change the water.

Check for compressed air supply. It shall not be less than 4 Kg/cm².

Fill the coating solution in the holding tank and set the gun validation.

Equipment Details:

Name of the equipment :  Ganscoater

Manufactured By : Gansons Limited.

Equipment Specification:

Equipment No.CapacityLocation
POGAC–0140-70 Kg (36” Pan)

70-150 Kg (48” Pan)

Coating room

Machine Major parts and it`s functions

Sr. No.Name of the machine partFunction
01Coating PanTo load the tablets for coating.
02BafflesTo provide the movement to the tablets during coating
03Spraying assemblyTo spray the coating solution on the tablets.
04Control PanelTo control and the various functions of the machine.

 Procedure:

  • Switch on the main power supply of the machine.
  • Ensure that line clearance has been taken to start the batch.
  • Transfer the uncoated tablets to the coating area.
  • Divide the batch in different lots if required.
  • Ensure the cleanliness of coating pan which is to be used for coating and ensure that swab for coating pan is passed.
  • Open the acrylic window and charge the uncoated tablets in the coating pan as mentioned in BMR.
  • Control panel of the machine is as follows
CONTROL

OFF        ON

  HOOTER

    RESET

 EMERGENCY
PLC/MMI

OFF        ON

PAN LIGHT

OFF        ON

DOSING PUMP

    OFF        ON

Click on the “SELECT MENU” from the screen.

Click on the “PASSWORD” from the below screen.

AUTO MODE

Click on the “LOG IN” from the below screen and enter the password.

Click on the “SET PARAMETERS” from the below screen

                      AUTO MODE

Set the inlet air temperature, Exhaust air temperature, from below screen as mentioned in BMR. Click on the “MAIN MENU” to get the home screen.

Click on the “CONTROL PANEL” from the below screen

AUTO MODE

Select the machine mode to “AUTO” and Click on the next button (>).

AUTO MODE

Start the EXHAUST BLOWER, by clicking on “START” button

Start the INLET BLOWER by clicking on “START” button.

Start the  PAN MOTOR by clicking on “START” button as per requirement.

Start the DOSING PUMP by clicking on “START” button after pre-heating of tablets.

Pre-warm the tablets at set temperature as mentioned in BMR.

Take the 20 tablets after pre-warming and record the weight in BMR.

Start the spray of coating solution as mentioned in BMR

                                  AUTO MODE

Click on the “MAIN” from above screen to get the home screen.

Start the coating pan and check the RPM, inlet temperature, exhaust temperature as specified in BMR.

After completion of the coating, allow the tablets to dry for specified time and pan RPM   as mentioned in BMR.

Allow the tablets to cool to room temperature.

Unload the tablets from coating pan into the polythene lined HDPE containers.

Check the weight of each container and record details on label and BMR, transfer coated tablets containers to Tablet Quarantine area.

Record the operation in the logbook in “Equipment Operation, cleaning & Maintenance  Log Book” as per SOP.

Remove the “EQUIPMENT STATUS” label and affix “TO BE CLEANED” label to the coating pan, solution container etc.

List of Annexure / Format

Not Applicable

References (if any)

Instruction Manual

Reason for revision

New SOP

 

 

 

 

 

 

 

9.0             Abbreviations

9.1             SOP          :           Standard Operating Procedure

9.2             No.            :           Number

9.3             HDPE        :           High Density Poly Ethylene

9.4             BMR          :           Batch Manufacturing Record

9.5             °C  :           Degree Celsius

9.6             i.e. :           That is

9.7             RPM          :           Revolution per Minute

END OF SOP

About Pharmaceutical Guidanace

Alice is the Author and founder of pharmaceutical guidance, she is a pharmaceutical professional having more than 18 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, Panacea Biotec Ltd, and Nectar life Science 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

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