Installation Qualification of Polarimeter

TABLE OF CONTENTS

Objective

Instrument Description & Identification

Installation Check List

Major Components

Utilities

Standard Operating Procedure / Calibration Procedure

Installation Verification

Summary of Installation Qualification

1. OBJECTIVE

This study aims to ensure proper installation of POLARIMETER, MODEL- ADP440+ at PharmaGuide Limited.

This study verifies:

Qualification of the unit installation and examination of all background information is performed to assure conformance to Rene Industries Limited and the manufacturer's 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 AND IDENTIFICATION

Description:

The ADP+ Polarimeter is a self-contained, easy-to-use instrument for measuring the rotation of optically active samples. The readings are displayed in either ˚angular or ˚Z ( international sugar scale) on a backlit widescreen LCD display.

Identification:

Manufacturer:

Instrument name:

Instrument ID:

Model Number:

Serial No:

Checked by:_______________

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
2.1	Basic unit (ADP440+ Polarimeter module)
2.2	Polarimeter tube (Centre filling glass tube with straight central arm for filling)
2.3	Operating instruction manual
2.4	Instruction Manual CD-ROM
2.5	Key-fob type ID tags (pack of 3)
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

4. MAJOR COMPONENTS

• Basic unit
• Polarimeter tube: (Center filling glass tube with straight central arm for filling).

ALSO READ: Qualification Protocol for Air Handling Unit (HVAC)

Basic Unit

Description	Specified	Checked By
Make	Bellingham + Stanley
Model No	ADP440+
Serial Number	P x 14057
Dimensions	L x W x H (640 x 340 x 150) mm
Light Source	Light Emitting Diode with interference filter 589 nm
Installation Consideration	Yes/No
Properly mounted, supported & connected	Yes/No
Properly labeled / Identified	Yes/No

5. UTILITIES

Electrical

Voltage: 110-230V

Frequency: 50-60 Hz

Maximum Current: 200mA

Checked by:_______________

6. SOP / CALIBRATION PROCEDURES

Identify and list the Standard Operating Procedures / Calibration Procedures

Title	Number	Checked By
Operation and calibration procedure of POLARIMETER

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, proofed, and grounded
5.	Instrument identification nameplate is visible
6.	Unit installed and secured in place as per manufacturer recommendations

7. SUMMARY OF THE INSTALLATION QUALIFICATION

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

8. CERTIFICATION STATEMENT

This installation Qualification document certifies that POLARIMETER complies/does not comply 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 Polarimeter