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Installation Qualification for FTIR

PHARMASKY

INSTALLATION QUALIFICATION

Fourier Transform Infrared Spectrophotometer (IR Affinity-1S)

VALIDATION PROTOCOL No :

Page 11 of 11


INSTALLATION QUALIFICATION

AREA

:

Quality Control Department

INSTRUMENT

:

Fourier Transform Infrared Spectrophotometer

INSTRUMENT ID

:

 

MAKE

:

Shimadzu

MODEL

:

IR Affinity-1S

SERIAL No.

:

 

This document details the static attributes of the FTIR located in Quality Control department and the services required for Installation of the instruments. It also provides evidence that the FTIR has been installed correctly and the installation specifications given by the manufacturer as well as the ones required by us have been met.

PROTOCOL

COMPILED BY

PROTOCOL

APPROVED BY

PROTOCOL

AUTHORISED BY

 

 

Quality Control

 

 

Quality Control

 

 

Quality Assurance


1.            TABLE OF CONTENTS

Section No.

Title

Page No.

1.       

Table of Contents

2

2.       

Purpose

3

3.       

Objective

3

4.       

Reference

3

5.       

Responsibility

3

6.       

Instrument Description & Identification

4

7.       

Installation check List

5

8.       

Major Components

6

9.       

Utilities

6

10.  

Standard Operating Procedure

7

11.  

Calibration Procedure

10

12.  

Installation Verification

10

13.  

Summary of Installation Qualification

11

14.  

Certification Statement

11

2.             purpose:

To ensure that the FTIR is installed as per the specifications given by the manufacturer and also meets the design criteria.

3.            Objective:

The objective of this study is to ensure proper installation of FTIR, IR Affinity-1S at XYZ Limited.

This protocol is applicable for installation of the FTIR. The Installation Qualification is an essential part of GMP documentation and serves as a base document for the validation activity.

This study verifies:

Ø  Qualification of the unit installation and examination of all background information is performed to assure conformance to XYZ Limited and manufacturer's specifications.

Ø  The Instrument meets the current regulatory requirements.

Ø  No unauthorized or unrecorded modifications have taken place.

Ø  Standard Operating Procedures (SOP), Calibration Procedures and Check-list have been identified and listed.

Ø  All critical instrumentation has been identified.

Ø  All utilities are properly connected.

Ø  All test reports, drawing, manuals, are available and maintained

4.            REFERENCE:  Operating Instruction Manual

5.            RESPONSIBILITY:

5.1        Validation officer/ QC Assistant Manager shall be responsible for installation.

5.2        QA Manager shall conclude and approve the results

 

6.            Instrument Description and IDENTIFICATION:

6.1        Description:

The IRAffinity-1 uses a high-energy long life ceramic light source, which sends light to a spherical mirror. The beam is then converged at the aperture, and is sent to the collimator to make parallel beams that are sent to the interferometer.

The beam splitter divides the light beam to the fixed mirror and the moving mirror. When the distance between the beam splitter and the fixed mirror equals the distance between the moving mirror and the beam splitter, the beams are in phase, and interfere constructively. When the moving mirror is displaced by ¼ of the wavelength of the beam from the source, the two beams will be out of phase and will interfere destructively. This optical path difference is measured very accurately via a He-Ne laser.

In the IRAffinity-1, the beam splitter is made of a potassium bromide substrate on which germanium is evaporated. This beam splitter is very easily damaged by moisture, and as such, it is protected with a moisture resistant coating. Furthermore, the instrument is equipped with a dehumidifier. Nevertheless, care must be taken to avoid moisture building up in the instrument.  

These two beams are then reflected by two flat mirrors, and are converged at another mirror. The resulting parallel interfered beam then goes through the sample compartment. Thereafter, the beam goes through another converging mirror and then to the detector. For this instrument, the detector is a deuterated L-alanine triglycene sulfate pyroelectric detector, which has a high sensitivity and does not require cooling.

6.2        Identification:

Manufacturer    

:

Shimadzu

Instrument Name

:

Fourier Transform Infrared Spectrophotometer

Instrument ID

:


Model Number

:

 IR Affinity-1S

Serial No                               

:    


Purchase Order Number

:    


Date Received

:    


Date Installed

:    


 

 Checked by: 

7.            INSTALLATION CHECKLIST:

Sr. No

ITEM

7.1

Instrument Appearance Check

7.2

Parts Check

7.3

Installation Site Check


Sr. No

Items

Observation

Checked by

7.1

Instrument Appearance Check

 

 

7.2

Parts Check

 

 

7.3

Installation Site Check

 

a.         Dry and indoors

 

 

 

b.        Away from draughty or hot equipment like fans or heater

 

 

 

c.         Within reach of power point

 

 

 

d.        Away from potential source of interference, such as RFI generating equipment

 

 

 

e.         Not to use a power circuit that also has large motors

 

 

 

f.          Away from direct sunlight

 

 


Checked by:

8.            MAJOR COMPONENTS:

8.1        Basic Unit

Description

Specified

Checked By

Make

Shimadzu

 

Model No

IR Affinity-1S

 

Sr. No


 

Dimensions

Width

514 mm

 

Height

273 mm

 

Depth

606 mm

 

Weight

30 kg

 

Installation Consideration

Yes / No

 

Properly Mounted, Supported & Connected

Yes / No

 

Properly Labeled / Identified

Yes / No

 


Checked by:

9.            Utilities:

9.1        Electrical

Supply voltage

AC 100 - 240 V

 

Frequency

50/60 Hz

 

Power consumption

150 VA (at used), 4VA (at standby)

 


Checked by:
 

10.        Standard Operating Procedures

10.1         Login to the computer using your ID and password.

10.2         Turn on the FTIR machine (the power button is in the front)

10.3         Start IRSolution software. Start -> All Programs -> IRSolution

10.4         A window may pop up asking to remove marked data. Click yes.

10.5         Another window may pop up saying “Autoadjust required. Perform autoadjust now?” Click yes. a. This may take several minutes

10.6         On the top toolbar, click on Measurement -> EasyScan

a.      A window will pop up with some options. Typically, nothing needs to be adjusted, but you can select the range of wavenumbers scanned (in cm-1).

b.      Name the data file and add any comments. Then click ok.

10.7         It will ask to execute BKG (background) measurement. Click yes.

10.8         It will ask to execute BKG measurement again. Click no.

10.9         Now it is time to place the sample in front of the beam. There is a triangular sample holder that can be used. Tape can also be used to hold the sample in front of the beam. (The beam is red; make sure it is going through the part you want to test).

10.10     Once the sample is in place, close the chamber and click ok. The spectrum will be acquired

10.11     It will ask “Are you all right?” Click ok.

10.12     Save the XPS file if desired. It contains the spectrum and lists peaks in a table.

10.13     Now, you can export the data to a text file for use in Excel or other software if desired. File -> Export. Save as (ASCII) which will make a .txt file.

10.14     See the figure below to see what the screen should look like.

10.15     A peak or spectrum search can now be performed by clicking on search. It is recommended to try both as one may find a better match than the other.

10.16     The Y-Axis can be changed to absorbance or % transmission by clicking Graph -> Y-axis mode -> Tra or Abs

10.17     The blue – red = green button (circled in the image below) will put both the acquired spectrum and the matched spectrum on the same graph.

10.18     When finished   

a.      Log off

b.      Close the software

c.      Remove the sample

d.      Turn off the power

11.        CALIBRATION PROCEDURES:  

11.1         Ensure that the FTIR System is placed on a clean and dust free platform.

11.2         Ensure that the instrument has been connected to power supply. Ensure that the   all communication cords between the units are connected properly.

11.3         Dry indicator checks; the check must be done before turning the instrument ON.   There are two indicators – an orange lamp as Dry indicator and green lamp as Power indicator on the front. Dry indicator light shows the humidity in the interferometer of the FTIR even if it is off. Always confirm that the Dry indicator is on.

11.4         Silica gel check; this check must also be done before turning the instrument ON.

11.5         Power spectrum check; this is done by clicking [BKG Scan] icon to perform background scan measurements. A power spectrum is displayed after scanning.

11.6         Click the [Data] tab and then set scan parameters such as the number of scans and resolution.

11.7         Enter filename and sample information as “polystyrene film” and save in a specific folder as “Calibration of FTIR”.

11.8         Insert in the polystyrene film provided in the sample chamber cassette of the FTIR and start measurements.

11.9         A typical spectrum of polystyrene will appear.

11.10     Check the instrument for the following parameter and record the results in calibration sheet.

11.10.1        Wave no accuracy

11.10.2        Resolution

12.        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 name plate is visible

 

 

6.

Unit installed and secured in place as per manufacturers recommendations

 

 


13.       
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

 

 


14.        CERTIFICATION STATEMENT:

This installation Qualification document certifies that FTIR has been found to be complies / not complies with the entire requirement contained in the protocol.

 

Signatories

Signature
Date

Executed by

Quality Control

 

 

Reviewed by

Quality Control

 

 

Approved by

Quality Assurance Manager

 

 



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