ProductionQuality Assurance

Operation & monitoring of Manufacturing Tank & holding tank

Operation & monitoring of Manufacturing Tank (1500 liters, 500 liters) & holding tank (300 liters)

PURPOSE : To describe the procedure for operation & monitoring of manufacturing tanks (1500 liters,500 liters ) &  holding tank (300 liters).

SCOPE : This SOP is applicable for operation & monitoring of manufacturing tanks & holding tank at  SVP manufacturing facility.

References

User manual of manufacturing & holding tanks

RESPONSIBILITY

Department concern Person:

To verify that employees are trained before performing or operation any task relevant to this SOP.

To Maintained the record.

Production Head:

To ensure the compliance of SOP.

Quality Assurance Persons:

To verify that all the instructions are followed properly as per the given SOP.

To ensure implement of the SOP.

DEFINITION & ABBREVIATION(S)

CIP : CIP stands for “ Cleaning In Place”. CIP is the method of cleaning of interior surface tanks, pipes, filters assembly, interior associate fittings without disassembly. Due to the use of CIP system, cleaning is faster, less labor intensive, more repeatable & poses less of exposure risk.

CIP has started as manual practice involving tanks, centrifugal pump & connection to the system being cleaned. CIP has evolved now fully automated system operate by PLC, multiple balance tanks, sensors, controllers & specially designed spray nozzle system.

SIP : SIP stands for “Sterilization In Place”. SIP is the method of sterilization of production equipment (interior surface tanks, pipes, filters assembly, interior associate fittings without disassembly). SIP system is used in that area where germ reduction play a decisive role.

Sterilization is carried out with pure steam of above 121ºC over a period of more than or equal to 30 minutes. the duration varies according to application and system type.

Abbreviations

C.C. No. : Change Control Number

WFI  : Water For Injection

CIP  : Cleaning In Place

SIP: Sterilization In Place

FFS : Form Fill Seal

SFS : Sterile Filter Space

HMI : Human Machine Interface

PLC : Programing Logic Control

PROCEDURE:

Check points prior to operation:

Ensure availability of electrical supply to the control panel of tanks.

Ensure availability of oil & moisture free compressed air approximately 7 kg/cm2.

Ensure all the gauges, sensors are calibrated.

Ensure HMI is properly working.

Verify the clamps gasket for tightness.

Operation of mfg. tanks(1500 liters & 500 liters)

SVP manufacturing tanks operated with semi-automatic process & operate with HMI/PLC to avoid minimum manual interruption.

Operation to be performed with following control panel.

Control panel of manufacturing tanks is located in manufacturing room II & there is common PLC/HMI for all the manufacturing tanks.

Switch ON the mains supply of panel electrical panel with mcb box. & switch “ON” the panel With “ RED COLOUR” switch located in the control panel.

Before switch ON the panel verify that emergency switch is in release position.

After switch ON the panel home screen will appear on HMI indicating company name, manufacturer name & system name.

To start the process & to check & verify the parameters click on the “LOGIN” indication displayed on the screen.

After login mention the user name & password to go to main menu.

There are three level password protection in the system.

Operator

Supervisor

Manager

All have separate user name & password.

After login following “MAIN MENU” will display

Main menu contain different icons to run the process & to check the set parameters.

On the “ALARAM” option alarm history during the process can be visualize due to process or utility error  & alarm can be reset by the “Hooter RESET” button mentioned on control panel.

In the “MODE” option “MANUAL & STAND BY” option provided for operation of tanks.

In the “CHANGE PASSWORD” option password to operate the HMI can be edited or changed.

In the “SET PARAMETER” option set parameter for operation, CIP & SIP can be verified.

With the “P& ID”  option process operation could be performed & verified.

With the “PRINTER” option print out of SIP process of tanks & filtration skid can be taken.

With the “HOME SCREEN” option can be back to home screen.

With the P & ID icons for mixing, transfer, jacket cooling or heating system or CIP,SIP can be operated.

If we touch any red colour indication on P & ID screen, it will become green & that function will be start & to stop the operation that green indication will again touch & same function will stop.

Temperature, conductivity, pH of solution in the tank can be checked & verified with the HMI.

For the 1500 liters manufacturing tank  in-built CLT has been provided to verify the volume & for 500 liters manufacturing tanks load cell has been provided to check the weight of solution & it will be displayed on the control panel.

To run the mixer located on the bottom of the tank we have to touch the RED mixer option & it will become green & mixer of tank will start, same to be press again to stop the mixer & mixer colour will become red again & mixer of the tanks will stop.

Mixer will show the rotation in “htz” unit.

 Operation of holding tank (300 liter)

SVP holding tank operated with semi-automatic process & operate with HMI/PLC to avoid minimum manual interruption.

Operation to be performed with following control panel.

Control panel of holding tank is located in filling room.

Switch ON the mains supply of panel electrical panel with mcb box. & switch “ON” the panel With “ RED COLOUR” switch located in the control panel.

Before switch ON the panel verify that emergency switch is in release position.

After switch ON the panel HOME/WELCOME screen will appear on HMI indicating company Name, manufacturer name & system name, location.

To start the process & to check & verify the parameters click on the “LOGIN” indication displayed on the screen.

After login mention the user name & password to go to main menu.

There are three level password protection in the system.

  • Operator
  • Supervisor
  • Manager

All have separate user name & password.

After login following “MAIN MENU” will display.

In the “MODE” option “MANUAL & STAND BY” option provided for operation of tanks.

By pressing “MANUAL” the manual mode, manual operation of tank could be performed.

In the “CHANGE PASSWORD” option password to operate the HMI can be edited or Changed & only manager is authorized to operate this function.

In the “SET PARAMETER” option set parameter for operation, CIP & SIP can be verified.

With the “P& ID”  option process operation could be performed & verified.

With the “PRINTER” option print out of SIP process of holding tank & transfer pump to be taken.

With the “HOME SCREEN” option can be back to welcome screen.

With the P & ID icons for holding tank, transfer, jacket cooling or heating system or CIP,SIP can be operated.

If we touch any red colour indication on P & ID screen, it will become green & that function will be start & to stop the operation that green indication will again touch & same function will be stop.

Temperature, pH, conductivity of solution in the tank can be checked & verified with in the P & ID option of HMI. 

REVISION HISTORY