OQ of Blister Packing Machine (BQS)

OQ of Blister Packing Machine (BQS)

TABLE OF CONTENT 

  • Purpose
  • Scope
  • Responsibilities
  • Procedure
  • Operational qualification tests
    • 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
    • Operational Qualification Tests Status
  • List of Standard Operating Procedures
  • Data Analysis, Summary of OQ & Recommendations
  • Amendment record
  • Conclusion
  • 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 system in order to:

  • Ensure that the equipment meets the Operational/Design limits as per user requirements.
  • 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) its accessories to be installed .

  • RESPONSIBILITIES
    • 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.
    • It is the responsibility of the client to check and approve the Operational qualification.
  • 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 NUMBER CRITICAL FEATURE
5.1 Testing of Programmable Logic Controller’s Processor
5.2 Verification of Man Machine Interface Screens – MMI
5.3 Power & Emergency Failure Recovery Verification
5.4 Emergency Operation Verification
5.5 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 –
Indicator Specified Actual Meet the Spec.

(Yes / No)

Initial / Date
Power LED LED on when PLC power applied
Run LED LED on when PLC is in RUN Mode
Error LED LED on when PLC is in error
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.
  • 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 Screen This screen will displayed whenever the pc controls system starts Operator station will Display the Start Up screen at the startup.
Menu Screen Press 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 Screen Change the m/c. parameters like min/ max and set point values and accordingly check the result of the process functioning The machine will operate according to the set values.
Alarm Screen Click the alarm button from any screen The alarm screen will activate.
  • 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
Test Results Meets Test

(Yes / No)

Initial / Date
Configurable Parameters before shut down.

 

 

Parameter 1: _______________

 

Parameter 2: _______________

 

Parameter 3: _______________

Main Power Shut Down  

Equipment/PLC stops in a safe and secure condition.

 

Main Power Restored  

Equipment/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 displayed Before

shut down:

 

 

After

shut down:

  • 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
Test Acceptance Criteria Meets

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.
  • 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
Simulation Procedure Excepted Result Actual Result as Expected?

(Yes / No)

Initial / Date

mm/dd/yy

Air Pressure Minimum Release air Machine stops at Zero position
Front guard open Open the guards

 

Machine stops at Zero position
Water supply off Stop the water supply Machine stops at Zero position
Low air supply Reduce the air supply Machine stops at Zero position
PVC foil end Remove PVC foil Machine stops at Zero position
Aluminium Foil Remove Aluminium foil Machine stops at Zero position
Vacuum pump off Stop the vacuum pump Machine stops at Zero position
MCB trip Put off MCB Machine stops at Zero position
Low temp. forming Less than set Machine stops at Zero position
High temp. forming More than set Machine stops at Zero position
Low temp. sealing Less than set Machine stops at Zero position
High temp. sealing More than set Machine stops at Zero position
Indexing Sensor ON Web slippage in indexing Machine stops at Zero position
  • Operational Qualification Tests Status

The table below lists the tests performed and related results.

Test Number

 

Critical Feature

 

Pass / Fail
Pass Fail
5.1 Testing of Programmable Logic Controller’s Processor
5.2 Verification of Man Machine Interface Screens – MMI
5.3 Power & Emergency Failure Recovery Verification
5.4 Emergency Operation Verification
5.5 Verification of Alarms
  • LIST OF STANDARD OPERATING PROCEDURES 
S. No. Description SOP No Verified By Date
1 Operating Procedure of Blister Packing Machine (BQS).
2 Cleaning Procedure of Blister Packing Machine (BQS).
3 Preventive maintenance of Blister Packing Machine (BQS).                                                      

  

  • Data Analysis, Summary of OQ & Recommendations

8.0              AMENDMENT RECORD

Sr. No.

Item Name

Remarks

Signature and Date

    Note: Any changes made in the system must be recorded in this sheet.

  • CONCLUSION

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About Pharmaceutical Guidanace

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit 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. He 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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