Operational Qualification of Disintegration Tester

TABLE OF CONTENTS

1. Objective
2. Purpose
3. Operational Testing
4. Control panel testing
5. Standard Operating Procedure verification
6. Instrumentation Calibration
7. Summary of Operational Qualification

1. OBJECTIVE

The purpose of this study is to qualify and certify the operational performance of DISINTEGRATION TESTER at PharmaGuide Limited.

This study verifies:

• Verifies that the Instrument consistently operates within a specified set of parameters under normal operational conditions.
• Assure that the Instrument performance is adequate to support the process for which the Instrument is intended for
• Demonstrates the completeness and adequacy of Standard Operating procedure and calibration procedure.

2. PURPOSE

The purpose of this protocol is to establish documentary evidence to ensure that the installed DISINTEGRATION TESTER will operate reproducibly and consistently within its full dynamic range of operation according to the manufacturer’s specifications.

3. OPERATING TESTING

The operational procedure of the DISINTEGRATION TESTER was checked as per the manual of the instrument. Refer to Annexure-I for the operational procedure.

4. CONTROL PANEL TESTING

Objective:

To verify that all the components on the control panel function as designated

Testing Procedure:

1. Check all the components on the control panel are properly labeled/identified
2. Turn 'ON' the power to the control panel
3. Set the required 'Controls
4. Verify the function of each key/component on the panel against its specified (As mentioned below)
5. Observe and record the responses of each component of the panel.

Component: 

Power toggle switch

Function:

To ON or OFF the instrument.

Step No.	Method of Testing	Acceptance Criteria	Observation
1	Put ON the toggle switch provided rear right-hand side. (Ensure the timer LED is OFF and temperature LED is OFF Ensure that the timer field is in xxxx mode)	The display shall show the last reached time value in the timer field and the current bath temperature in the temp field. Bath LED shall glow.
2	Put OFF the toggle switch provided rear right-hand side	All LEDs shall be switched OFF.

Checked By:__________     Verified By:__________

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Component: Set key
Function: To set the time in the timer field in combination with enter key

Step No.	Method of Testing	Acceptance Criteria	Observation
3	Put ON the toggle switch provided rear right-hand side	The display shall show the last reached time value in the timer field and the current bath temperature in the temp field. Bath LED shall glow.
4	Press the ' Set ‘ key	No change in the Timer and Temp field display, the set key LED  shall glow  and off  automatically  after 10 seconds
5	Press the 'Set' key and then the 'Timer' key.	The display shall show the previous set value in the timer field with rightmost digits flashing. The set LED shall glow and off after 10 seconds automatically. The previous set time value in the timer field changes to the last reached time
6	Press the 'Set' key, 'timer' key ', and keep on pressing the ' D'  key.	The display shall show the previous set value in the timer field with the right-most digit flashing. The flashing digit shall increase for every key press till 9 and then return to 0. Set LED shall be OFF after 10 seconds (if the operation of any key stops for more than 10 seconds).
7	Press the 'Set' key, 'Timer' key, and ' D'  key once, and the 'Enter' key	The flashing digit value shall increase by one unit.  (if the digit value is in between 0-8). If the digit value is 9, the display shall show '0' in the current flashing digit.
8	Press the 'Set' key and then the 'Enter' key.	The display shall show the last reached time value changing from xx.xx to - x.xx.
9	Press the 'Set' key and then the 'Enter' key.	The display shall show the last reached time value changing from -x.xx to xx.xx
10	Press the 'Set' key and then Temp' key.	The display shall show the previous set value in the temp field with the rightmost digit flashing. The set LED shall glow and off after 10 seconds automatically. The previous set temperature in the temp field changes to the current bath temperature.
11	Press the 'Set' key, and 'Temp' key' and keep on pressing the 'D’ key.	The display shall show the previous set value in the temp field with the rightmost digit flashing. The flashing digit shall increase for every key press till 9 and then return to 0. Set LED shall be OFF after 10 seconds (if the operation of any key stops for more than 10 seconds).
12	Press the 'Set' key, 'Temp' key' and ' D'  key once and the 'Enter' key	The flashing digit value shall increase by one unit.  (if the digit value is in between 0-8). If the digit value is 9, the display shall show '0' in the current flashing digit.

Checked By:_________          Verified By:__________

Component: Temp key
Function: To switch ON/OFF heater.

Step No.	Method of Testing	Acceptance Criteria	Observation
13	Press the 'Temp' key.	Temp LED shall glow and the display temperature shall start increasing to the set temperature slowly (heater is on).
14	Press the 'Temp' key.	Temp LED shall off and display temperature shall start decreasing to room temperature slowly (heater is off).

Checked By:________             Verified By:___________ 

5. STANDARD OPERATING INSTRUCTIONS VERIFICATION

The following Standard Operating Procedures were verified as important for the Effective Performance of the Disintegration Tester.

Sr. No.	SOP TITLE	SOP NUMBER	VERIFIED BY
1	Operation Procedure of Disintegration Tester
2	Calibration Procedure of Disintegration Tester

Refer SOP of the Disintegration Tester

6. INSTRUMENT CALIBRATION VERIFICATION

SOP Title: CALIBRATION PROCEDURE OF DISINTEGRATION TESTER

SOP No: 

Calibration Date:

7. SUMMARY OF THE OPERATIONAL QUALIFICATION

Description	Yes/No	Checked by
All acceptance Criteria outlined in the Operational qualification were met
All applicable data sheets were signed and checked and verified.

8. POST-APPROVAL

	Signatories	Signature	Date
Executed by	Quality Assurance
Reviewed by	Quality Control
Approved by	QA Manager

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