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Operational Qualification of Capsule Printing Machine

  • PURPOSE: 
  • To describe the Operational Qualification of Capsule Printing Machine its accessories and to define the specification of the system in order to:
  • ensure that the machine meets the Operational / Design limits as per user requirements
  • ensure that the machine will be operationally qualified in accordance with current Good Manufacturing Practices.
  • SCOPE:
  • The scope of this document applies to the operational qualification Capsule Printing Machine
  • 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 Capsule Printing Machine 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 machine.
  • 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 Main Panel/Control Panel
5.2 Power & Communication Failure Recovery Verification
5.3 Operational Qualification Tests Status
  • Main Panel / Control Panel.
  • Purpose – To verify that the response of the machine at the input from various Pushbutton / Switches on control or main panel is as per the system design.
  • Test machine – None Required.
  • Procedure – Give inputs from various Push buttons & Switches on Control Panel / Main Panel & observe the Response from the machine.
  • Acceptance Criteria – The machine shall respond as mentioned in the target column of the table given below.

 

  • Test Results
 Input  Target  Actual  Test Done by  Date
Press START Switch Machine shall start running
Press STOP switch Machine shall stop running
Rotate Auto/Jog Rotary Switch to Jog position and press Jog Push Button . Machine shall start running till Jog Push Button is pressed
Rotate Auto/Jog Rotary Switch to Auto position and press Jog Push Button. Machine shall not start running
Press START Switch Machine shall start running
Rotate Speed Regulator Knob in clockwise direction Feed Disc speed shall increase
Rotate Speed Regulator Knob in anticlockwise direction Feed Disc speed shall decrease

Conclusion:

PASS                                    FAIL

Verified By:     _______________________           Date:   ______________

Checked By: ________________________            Date:     ______________

  • Power & Communication Failure Recovery Verification
  • Rationale – To verify that in the event of a power loss or communications failure, the machine will stop in safe condition.
  • Test machine – None Required.
  • Procedure for Power and Communication Failure Recovery test – Operate the machine in automatic mode or as directed in the User Manual. While the machine is operating, shut down the power to the main control panel. Record if the machine stops in a safe and secure condition. Wait for 5 minutes then restore power to the machine. Check whether system is start running once the power is restored. The system is not starting of its own, restart the machine.
  • Acceptance criteria – At step 5.2.3.2 the machine stops in a safe and secure condition. At step 5.2.3.4 the machine should not start of its own after the power is restored without user permission At step 5.2.3.5, the machine can be restarted with NO problems.
  • Power and Communication Failure Recovery test results
Test Results Meets Test

(Yes / No)

Test Done by Date
Main Power Shut Down Machine shall stop in a safe and secure condition.
Main Power Restored Machine shall not start on its own without user permission
Machine shall be restarted with NO problems.  

 

Press Emergency Stop Machine shall stop in a safe and secure condition.
Release Emergency Stop Machine shall not start on its own without user permission
Machine shall be restarted with NO problems
  •  Conclusion:
  • PASS                                    FAIL
  • Verified By:     _______________________           Date:   ______________
  • Checked By: ________________________            Date:     ______________
  • RPM verification
  • Purpose – To verify the RPM stirrer.
  • Test equipment – Tachometer required.
  • Procedure – Start the equipment as per user manual. Set the RPM and observe the rotation of the equipment for ‘1’ minute (Note down the value in respective trial column) using tachometer. Continue the procedure no: 5.3.3.2 for totally ‘3’ times.
  • Acceptance Criteria – The average RPM of the stirrer should match with the set RPM.

 

  • RPM verification test results
Set RPM Trial-1

No of Revolution

Trial-2

No of Revolution

Trial-3

No of Revolution

Average RPM

 

Test Done by Date
  • Note:
  1. a) Enter the no of rotation for ‘1’ minutes in the trial –1, 2 & 3 columns.
  2. b) Average RPM = (Trial-1 + Trial-2 + Trial-3) / 3
  • Conclusions
  • PASS                                    FAIL
  • Checked By: ________________________            Date:     ______________
  • Verified By:     _______________________           Date:   ______________

 

  • Operational Qualification Tests Status
  •  The table below lists the tests performed and related results.
Test Number  Critical Feature

 

Pass Fail Deviation Found
Yes No
5.1 Main/Control Panel
5.2 Power & Communication Failure Recovery Verification
5.3 RPM Verification
  • LIST OF STANDARD OPERATING PROCEDURES
Sr. No Description SOP No Verified By Date
1 Operating Procedure of    Capsule Printing Machine
2 Cleaning Procedure of Capsule Printing Machine
3 Preventive maintenance of Capsule Printing Machine
  •  DATA ANALYSIS , SUMMARY OF OQ & RECOMMENDATIONS
  • AMENDMENT RECORD
Sr. No. Item Name Remarks Signature & 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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