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Urs Ftir

The document outlines the User Requirement Specification (URS) for an FTIR (Fourier-transform infrared) spectrometer intended for the Quality Control department at Julphar Pharmaceuticals PLC in Ethiopia. It details the purpose, required features, and technical specifications of the instrument, including compliance with pharmacopeia standards and operational qualifications. The document also includes an approval section for key personnel involved in the procurement process.

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ashenafi Gezahegne
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290 views5 pages

Urs Ftir

The document outlines the User Requirement Specification (URS) for an FTIR (Fourier-transform infrared) spectrometer intended for the Quality Control department at Julphar Pharmaceuticals PLC in Ethiopia. It details the purpose, required features, and technical specifications of the instrument, including compliance with pharmacopeia standards and operational qualifications. The document also includes an approval section for key personnel involved in the procurement process.

Uploaded by

ashenafi Gezahegne
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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JULPHAR PHARMACEUTICALS PLC.

(ETHIOPIA)

USER REQUIREMENT SPECIFICATION

Name Item : FTIR (Fourier-transform infrared) spectrometer


Functional area ( Department) : Quality Control
URS No:

Name of Instrument: FTIR (Fourier-transform infrared) spectrometer

Effective data:

1
JULPHAR PHARMACEUTICALS PLC. (ETHIOPIA)

USER REQUIREMENT SPECIFICATION

Name Item : FTIR (Fourier-transform infrared) spectrometer


Functional area ( Department) : Quality Control
URS No:

1. Approval
Signing this approval page of the user requirement specification (URS) signifies
agreement with the content of this document. If any modifications become necessary,
an addendum will be prepared and approved accordingly.

Prepared by Designation Signature Date


Ashenafi Gezahegne QC Manager
Checked by Designation Signature Date
Sara Tadessa Sr. QA Pharmacist
Approved by Designation Signature Date
Tilahun Alemayehu QA Manager
Authorized by Designation Signature Date
Kedir Sherif Country Manager

2
JULPHAR PHARMACEUTICALS PLC. (ETHIOPIA)

USER REQUIREMENT SPECIFICATION

Name Item : FTIR (Fourier-transform infrared) spectrometer


Functional area ( Department) : Quality Control
URS No:

2. Purpose: The purpose of the user requirement specification (URS) for an FTIR
(Fourier transform infrared) spectrometer is to provide suppliers with the necessary

details to prepare a price quote, including the design and manufacture of the
equipment. The user requirement specification (URS) will be regarded as an integral
part of the procurement agreement with the selected instrument vendor. The
supplier or vendor will be expected to comply with the specification and conditions

outlined in this document, as well as the purchasing and delivery terms established
by the client.

3. The FTIR should have the following features (not limited):


3.1. The FTIR (Fourier transform infrared) should have software for operation and

control of the instrument.


3.2. The FTIR (Fourier transform infrared) should have a built in heater to effectively

remove humidity.
3.3. The FTIR (Fourier transform infrared) should be capable of interfacing with the

PC and should include an auto-validation feature for system performance


checks.

3.4. The FTIR (Fourier transform infrared) should be designed to meet the
requirements of both the British pharmacopeia (BP) and the United States

pharmacopeia (USP) standards.

3
JULPHAR PHARMACEUTICALS PLC. (ETHIOPIA)

USER REQUIREMENT SPECIFICATION

Name Item : FTIR (Fourier-transform infrared) spectrometer


Functional area ( Department) : Quality Control
URS No:

4. The FTIR (Fourier transform infrared) shall be used for:


4.1. The FTIR (Fourier transform infrared) should be capable of performing

identification tests on a variety of sample types including Solid, Liquid, Pellets,


pastes, powders, gels and gases (optional).
5. Technical Specifications

ITEM SPECIFICATION
 The FTIR should feature a high
throughput Michelson interferometer
with both fixed and moving flat mirror.
Interferometer  The interferometer must be sealed and
desiccated and equipped with an
automatic drying system to ensure
optimal internal condition
Beam splitter  KBr or Znse ( standard)
Scan range (Cm-1)  7.800- 350
Operational system  Microsoft windows
 The FTIR system should support addition,
Multiplication, Abs to % T conversion,
Data Processing Normalization, baseline correction, log
conversion, Smoothing, derivative data
processing system.
 The FTIR system should equip with
Spectrum Search spectrum search parameters and
spectrum library.
 The system should display High
Display wavenumber compression, Zooming,
Auto scaling, Overlay, Shift display
Printing  Report generator
 Container function with stored
Audit trail
interferogram/ back ground

4
JULPHAR PHARMACEUTICALS PLC. (ETHIOPIA)

USER REQUIREMENT SPECIFICATION

Name Item : FTIR (Fourier-transform infrared) spectrometer


Functional area ( Department) : Quality Control
URS No:

interferogram operation history,


password protection and log recording in
accordance with FDA 21 CFR part 11
compliance with electronic signature.
Power requirement  100-240 V, AC 50/60Hz
 The FTIR Provider or winning supplier
should install and perform operational
qualification (OQ) for the instrument
ensures that the system is set up
Installation, operational qualification & properly and meet all operational
training specification after installation.
 The FTIR provider or winning supplier
should provide application training for
the QC staff to ensure proper and
effective use of the instrument.
 Temperature : NMT 24oc
Environmental condition of installation site
 Humidity: NMT 55%
 User and Maintenance Manual
 Software guide
Documentation
 Qualification documents
 Certificate for compliance

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