SOP for Operational qualification protocol of Blister Packing Machine (BQS)

SOP for Operational qualification protocol of Blister Packing Machine (BQS)

  • PURPOSE
  • To describe the Operational Qualification procedure to be used during qualification of Blister Packing Machine (BQS), its accessories and to define the specification of the sytem in order to:
  1. Ensure that the equipment meets the Operational/Design limits as per user requirements
  2. Ensure that the equipment will be operationally qualified in accordance with Good Manufacturing Practices
  • SCOPE
  • This procedure applies to the Operational qualification of Blister Packing Machine  (BQS).
  • RESPONSIBILITIES
  • It is the responsibility of the manufacturer to prepare the Operational qualification protocol and identify the test parameters to be studied for qualifying the Blister Packing Machine (BQS) Operationally.
  • It is the responsibility of the client to check and approve the Operational qualification protocol.
  • It is the responsibility of the Manufacturer to perform all the tests with respect to Operational qualification and compiling data in co-ordination with client.
  • PROCEDURE
  • The following requirement / practices apply to PAM-PAC Blister Packing Machine  (BQS), Operational Qualification activities:
  • To verify the components design parameters.
  • Review the preventive maintenance procedures, cleaning procedures and general operational procedure to ensure that they are comprehensive for reliable performance of the equipment.
  • OPERATIONAL QUALIFICATION TESTS
  • The table below lists the tests to be performed as part of the Operational Qualification phase.
TEST NUMBERCRITICAL FEATURE
Testing of Programmable Logic Controller’s Processor
Verification of Man Machine Interface Screens – MMI
Power & Emergency Failure Recovery Verification
Emergency Operation Verification
Verification of Alarms
  • Testing of Programmable Logic Controller’s Processor
  • Rationale – To verify the normal operation of PLC Processor by observing the processor module’s LED status indicator after turning on the PLC.
  • Test Equipment – None required.
  • Procedure – Turn panel power to ON position – Turn PLC power to ON position –  Check that PLC Processor is in RUN Mode – Document the following indicators located on PLC front panel
  • Acceptance Criteria – The processor should function as specified in the verification table.
  • Verification results –
IndicatorSpecifiedActualMeet the Spec.

(Yes / No)

Initial / Date
Power LEDLED on when PLC power applied
Run LEDLED on when PLC is in RUN Mode
Error LEDLED on when PLC is in error
 

Battery LED

LED on when battery is low
If actual result is not like expected result turn power to panel “OFF” and notify to engineer. Document any discrepancies on the operational qualification deviation report.
  • Conclusions / Comments:PASS                                     FAIL
  • Verified By:              ________________________           Date:   ______________
  • Reviewed By:          ________________________           Date:   ______________
  • Verification of Man Machine Interface Screens – MMI (PC Control)
  • Rationale – To verify that the screens displayed by the MMI according to the system requirements.
  • Test Required – None Required
  • Procedure – Access the MMI and verify that all of the functions on each of the screens listed below confirm to the Manual. Record the results for each verification on test data sheets.
  • Acceptance Criteria – The system shall operate as per design specification. Results: MMI screen verification
 

Simulate

 

Procedure

 

Excepted Result

 

Meets Test

(Yes / No)

 

Initial / Date

 

Start Up ScreenThis screen will displayed whenever the pc controls system startsOperator station will Display the Start Up screen at the startup.
Menu ScreenPress any of the command buttons on the screen and check whether that particular screen opens.Particular screen should open irrespective of the current security level in which user has logged.
Process Parameter ScreenChange the m/c. parameters like min/ max and set point values and accordingly check the result of the process functioningThe machine will operate according to the set values.
Alarm ScreenClick the alarm button from any screenThe alarm screen will activate.
  • Conclusions / Comments:
  • PASS                                     FAIL
  • Verified By:              ________________________           Date:   ______________
  • Reviewed By:          ________________________           Date:   ______________
  • Power & Communication Failure Recovery Verification
  • Rationale – To verify that in the event of a power loss or communications failure, the equipment /PLC will stop in safe condition and the operating parameter will not be lost or corrupted.
  • Test equipment – None Required.
  • Procedure for main power fail test –
    • Operate the equipment in automatic mode or as directed in the User Manual.
    • Record three of the configurable operating parameters in the main power fail test table of results (below).
    • Record the displayed date and time in the main power fail test table of results (below).
    • While the equipment/PLC is operating, shut down the power to the main control panel. Record if the equipment/PLC stops in a safe and secure condition.
    • Wait for 3 minutes then restore power to the equipment/ PLC.
    • Restart the equipment/ PLC. Record whether the equipment/PLC starts normally, and note any adverse condition.
    • Verify that the parameters recorded in the step 2 are unchanged after the power failure.
    • Record the displayed date and time after the power failure.
  • Acceptance criteria –
    • At step 4, the equipment/PLC shall stop in safe and secure condition.
    • At step 6, the equipment/PLC shall restart normally, with no problems or adverse conditions.
    • After restart, the configurable parameters remain unchanged and the date and time are correct.
  • Main Power Failure Test Results
Main Power Fail Verification
TestResultsMeets Test

(Yes / No)

Initial / Date
Configurable Parameters before shut down.

 

Parameter 1: _______________

Parameter 2: _______________

Parameter 3: _______________

Main Power Shut DownEquipment/PLC stops in a safe and secure condition.
Main Power RestoredEquipment/PLC can be restarted with NO problems or adverse conditions. 

 

Configurable parameters after shut down.

 

Parameter 1: _______________

Parameter 2: _______________

Parameter 3: _______________

Date and time as displayedBefore

shut down:

After

shut down:

  • Conclusions / Comments:
  • PASS                                     FAIL
  • Verified By:              ________________________           Date:   ______________
  • Reviewed By:          ________________________           Date:   ______________
  • Emergency Operation Verification
  • Purpose – To deactivate the equipment in the event of an emergency stop.
  • Test equipment – None Required.
  • Procedure –
    • With the emergency stop pressed in, try to cause movement of an operating function.
    • With the equipment in operation, activate (press in) the emergency stop.
  • Acceptance Criteria –
    • The equipment will be inoperative.
    • The operation will ramp to a complete stop in four seconds or less.
  • Failsafe Results –
Emergency Stop
TestAcceptance CriteriaMeets

Spec.

(Yes / No)

Initial / Date

 

 

With the emergency stop pressed in, try to cause movement of an operating function.

 

 

The equipment will be inoperative.

With the equipment in operation, activate (press in) the emergency stop.

 

The operation will ramp to a complete stop in four seconds or less.
  • Conclusions / Comments:
  • PASS                                     FAIL
  • Verified By:              ________________________           Date:   ______________
  • Reviewed By:          ________________________           Date:   ______________
  • Verification of Alarms.
  • Rationale – To verify alarms function and respond according to the system design.
  • Test equipment – None Required.
  • Procedure –
    • Place the equipment into normal operation mode.
    • Trigger each alarm outline in the table below.
    • Verify that the specified alarm response is obtained and the correct alarm is displayed on the MMI Screen.
    • Once the alarm has been activated, resolve the problem and reset.
    • Verify that the equipment returns to normal operation mode.
  • Acceptance criteria –
    • The alarms function and respond according to the system design.
  • Results: Verification of Alarms
            Alarm Verification
SimulationProcedureExcepted ResultActual Result as Expected?

(Yes / No)

Initial / Date

mm/dd/yy

Air Pressure MinimumRelease airMachine stops at Zero position
Front guard openOpen the guardsMachine stops at Zero position
Water supply offStop the water supplyMachine stops at Zero position
Low air supplyReduce the air supplyMachine stops at Zero position
PVC foil endRemove PVC foilMachine stops at Zero position
Vacuum pump offStop the vacuum pumpMachine stops at Zero position
MCB tripPut off MCBMachine stops at Zero position
Sealing locksNot operatedMachine stops at Zero position
  • Conclusions / Comments:
  • PASS                                     FAIL
  • Verified By:              ________________________           Date:   ______________
  • Reviewed By:          ________________________           Date:   ______________
  • Operational Qualification Tests Status
  • The table below lists the tests performed and related results.
Test Number

 

Critical Feature

 

Pass / FailDeviation Found
PassFailYesNo
Testing of Programmable Logic Controller’s Processor
Verification of Man Machine Interface Screens – MMI
Power & Emergency Failure Recovery Verification
Emergency Operation Verification
Verification of Alarms
  • LIST OF STANDARD OPERATING PROCEDURES
S. No.DescriptionSOP NoVerified ByDate
1Operating Procedure of Blister Packing Machine  (BQS)
2Cleaning Procedure of Blister Packing Machine  (BQS)
3Preventive maintenance of Blister Packing Machine  (BQS)                                                     
  • Data Analysis, Summary of OQ & Recommendations
  •  AMENDMENT RECORD
Sr.No.Item NameRemarksSignature & Date
  • Note : Any changes made in the system must be recorded in this sheet
  • CONCLUSION
  • Prepared by                            Reviewed By                                             Approved by

 

 

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