Operational Qualification of UV Spectrophotometer UV 1800

TABLE OF CONTENTS

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

1. OBJECTIVE

The purpose of this study is to qualify and certify the operational performance of UV SPECTROPHOTOMETER, MODEL: UV 1800 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.

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2. PURPOSE

The purpose of this protocol is to establish documentary evidence to ensure that the installed UV SPECTROPHOTOMETER, MODEL- UV-1800 will operate reproducibly and consistently within its full dynamic range of operation according to the manufacturer’s specifications.

3. CONTROL PANEL TESTING

Objective: To verify that all components on the control panel function as designed.

Testing procedure:

1. Check all the components on the key panel are properly labeled/identified
2. Turn on the power to the key panel
3. Set the required controls
4. Verify the function of each Key/component on the panel against its specification
5. Observe and record the responses of each component of the panel

3.1 Control Panel Testing

To check the role of the control panel key

Control Panel Key	Use	Observation
START/STOP	This is the key for starting and stopping measurement once parameter setting has been completed
Auto zero	On pressing this key, the absorbance (transmittance) at the current wavelength will automatically be set to 0 abs (10% transmittance)
GOTO WL	This is the key used to change current wavelength
ENTER	When u enter a value, press this key after the value to set the entering value
>      <       ㅅ       V	These keys to move the cursor in the LCD screen upward/downward, or left/fright.
F1  F2 F3  F4	These are the keys corresponding to the function that are displayed at the bottom of the LCD screen
RETURN	Use this key to display to the previous screen
Print	Use this key to output a hard copy of the monitor screen
0 - 9	Use these keys to enter numeric values
CE	Use this key to clear a numeric value entry error. On pressing this key numeric value that has been entered will be cleared

Checked By:____________

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To check the mode menu screen

Sr. No	Key Operation	Display	Description	Observation
1	1	[Photometric]	Display the screen for selecting the Photometric mode measurement method
	2	[Spectrum]	Display the measurement parameter configuration screen for spectrum mode
	3	[Quantization]	Display the measurement parameter configuration screen for spectrum mode
	4	[Kinetics]	Displays the screen for selecting the kinetics mode measurement method
	5	[Time scan]	Displays the measurement parameter configuration screen for time scan mode
	6	[Multi-component]	Displays the measurement parameter configuration screen for multi-component
	7	[Bio-method]	Displays the screen for selecting the bio-method mode measurement method
	8	[Utilities]	Display the screen for performing the instrument utility setting
2	F1	[Load Parm]	Calls the condition stored in the built-in memory
3	F2	[FileMng.]	Used to perform various operations on stored files in the built-in memory
4	F3	[Mainte.]	Display the screen for performing inspection and maintenance of the UV-1800
5	F4	[PC Ctrl]	Allows controlling the UV-1800 via an external computer
-	RETURN	-	Log out the current user when the security function is on

4. STANDARD OPERATING INSTRUCTIONS VERIFICATION

The following Standard Operating Procedures were verified as important for the Effective Performance of UV SPECTROPHOTOMETER, MODEL: UV-1800.

Sr. No.	SOP TITLE	SOP No.	VERIFIED BY
1	Operation and calibration Procedure of UV SPECTROPHOTOMETER, MODEL-UV-1800

5. INSTRUMENT CALIBRATION VERIFICATION

SOP Title: Operation & Calibration Procedure for UV Spectrophotometer, MODEL: UV-1800

SOP No :

Calibration Date:

6. SUMMARY OF OPERATIONAL QUALIFICATION

Description	Yes/No	Checked by
All acceptance Criterion outlined in the Operational qualification was met
All applicable data sheets were signed checked and verified.
Standard operating Instructions/ calibration Procedures were verified for completeness and accuracy

	Signatories	Signature	Date
Executed by	Quality control
Reviewed by	Quality control
Approved by	Quality Assurance

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