Installation Qualification of UV Spectrophotometer UV-1800

TABLE OF CONTENT

1. Objective
2. Instrument Description & Identification
3. Installation Check List
4. Major Components
5. Utilities
6. Standard Operating Procedure / Calibration Procedure
7. Installation Verification
8. Summary of Installation Qualification

1. OBJECTIVE

This study aims to ensure proper installation of UV SPECTROPHOTOMETER, MODEL: UV-1800 at PharmaGuide Limited.

This study verifies:

• Qualification of the unit installation and examination of all background information are performed to ensure conformance to PharmaGuide Limited and manufacturer specifications.
• The Instrument meets the current regulatory requirements.
• No unauthorized or unrecorded modifications have taken place.
• Standard Operating Procedures (SOP), Calibration Procedures and

Checklists have been identified and listed.

• All critical instrumentation has been identified.
• All utilities are properly connected.
• All test reports, drawings, and manuals, are available and maintained

2. INSTRUMENT DESCRIPTION & IDENTIFICATION

Description

• The UV-1800 is a compact, double-beam UV-VIS spectrophotometer wrapped in a sleek form-fitting case.
• The UV-1800 uses a Czerny-Turner monochromator which provides for a bright optical system, in a compact design.
• The UV-1800 can be operated as a stand-alone system or with UV Probe software. 
• The UV-1800 is USB-memory ready, which enables users to save measurement data to USB memory for data analysis and printing on a PC. 
• Sophisticated and easy-to-use UVProbe PC software comes standard and makes data processing easy. Offering Spectrum, Photometric, Quantitation, Kinetics, Time Course, and Bioapplication modes, the UV-1800 is equipped to handle all of your laboratory needs.
• With an array of user-friendly features, the UV-1800 easily satisfies pharmacopeia requirements and the demands of university laboratories, government agencies, and the food industry.

Identification

Manufacturer:
Instrument Name:
Instrument ID:
Model Number:
Serial No.:

Checked By:_______________

ALSO READ: Installation Qualification of FTIR (IR Affinity-1S)

3. INSTALLATION CHECKLIST

Sr. No	Item
1	Instrument appearance check
2	Parts Check
3	Installation site check

Sr. No	Item		Observation	Checked by
1	Instrument appearance check
2	Part Check	Part No	Observation	Checked by
2.1	Basic unit
2.2	AC power cable
2.3	Instruction manual, operation guide
2.4	Instruction manual, system user guide
2.5	UV-1800 Inspection certificate
2.6	UV-Probe CD ROM
2.7	UV Probe tutorial
2.8	UV Probe software release note
2.9	UV Probe software release note
2.10	Shimadzu user authentication Tool instruction manual
2.11	Software agreement license
3	Installation site Check
3.1	Dry and indoors
3.2	Away from draughty or hot equipment like fans or heater
3.3	Within reach of PowerPoint
3.4	Away from potential sources of interference, such as RFI-generating equipment
3.5	Not to use a power circuit that also has large motors
3.6	Away from direct sunlight

Checked By:_______________

4. MAJOR COMPONENTS

Basic Unit

Description	Specified	Checked By
Make
Model No.
Sr. No.
Dimensions
Light Source
Installation Consideration	Yes/No
Properly mounted, supported & connected	Yes/No
Properly labeled / Identified	Yes/No

Checked By:_______________

ALSO READ: SOP for Calibration of Shimadzu UV–1800 UV Spectrophotometer

5. UTILITIES

Electrical

Voltage	110 - 230V
Frequency	50 - 60 Hz
Maximum Current	200 mA

Checked By:_______________

6. SOP / CALIBRATION PROCEDURES

Identify and list the Standard Operating Procedures / Calibration Procedures

Title	Number	Checked By
Operation and calibration procedure of UV SPECTROPHOTOMETER

7. INSTALLATION VERIFICATION

Sr. No	Consideration	Yes/No	Checked By
1.	Major components are securely anchored and protected from shock
2.	There is no observable physical damage
3.	Sufficient room for servicing provided
4.	Required electrical connections are tight and weather proofed and grounded
5.	Instrument identification nameplate is visible
6.	Unit installed and secured in place as per manufacturer recommendations

8. SUMMARY OF THE INSTALLATION QUALIFICATION

Sr. No	Description	Yes/No	Checked By
1.	All acceptance criteria set forth in the Installation Qualification was met
2.	All specifications verified
3.	Deviations if any

9. CERTIFICATION STATEMENT

This installation Qualification document certifies that the UV Spectrophotometer is complies / not complies with the entire requirement contained in the protocol.

	Signatories	Signature	Date
Executed by	Quality control
Reviewed by	Quality control
Approved by	QA Manager

ALSO READ: Operational Qualification of UV Spectrophotometer UV 1800