Professional Documents
Culture Documents
Agilent Rid Urs
Agilent Rid Urs
,
Puducherry
Analytical Research and Development
USER REQUIREMENT SPECIFICATION FOR
TITLE
REFRACTIVE INDEX DETECTOR
Approved date
URS No. URS/D-AD/003-02
Page No. 1 of 13
Cover page 01
3.0 Purpose 04
4.0 Scope 04
5.0 Responsibility 04
12.0 References 08
13.0 Attachment 08
PROTOCOL APPROVAL
SIGNATUR
RESPONSIBILITY NAME DESIGNATION
E & DATE
Prepared by (AD)
Reviewed by (AD)
Reviewed by (QA)
Approved by (QA)
Steril-Gene Life Sciences (P) Ltd.,
Puducherry
Analytical Research and Development
USER REQUIREMENT SPECIFICATION FOR
TITLE
REFRACTIVE INDEX DETECTOR
3.0 PURPOSE
4.0 SCOPE
The user requirement specification (URS) is applicable to the proposed refractive index
detector for Steril-Gene Life Sciences (P) Ltd. Puducherry.
5.0 RESPONSIBILITY
Department Responsibilities
Analytical Research and
To prepare and review the URS
Development
Refractive index detector plays a crucial role in detecting and quantifying compounds
that lack chromophores or fluorophores of raw materials and drug products
REQUIREMENT
URS-ID DESCREPTION/SPECIFICATIONS
S
REQUIREMENT
URS-ID DESCREPTION/SPECIFICATIONS
S
Operational procedures
REQUIREMENT
URS-ID DESCREPTION/SPECIFICATIONS
S
REQUIREMENT
URS-ID DESCREPTION/SPECIFICATIONS
S
REQUIREMENT
URS-ID DESCREPTION/SPECIFICATIONS
S
As per below requirements the E-sign shall be considered
legally valid,
Adopted by the signer with the intent to sign the
document.
Attached to or logically associated with the document.
SERVICE REQUIREMENTS
Software and service Agreements like AMC,QTA,SLA
SR-01
but not limited too
Service
SR-02 Software release notes.
Requirements
Software and service manuals like operational manual,
SR-03
user manual, data sheets but not limited too
Steril-Gene Life Sciences (P) Ltd.,
Puducherry
Analytical Research and Development
USER REQUIREMENT SPECIFICATION FOR
TITLE
REFRACTIVE INDEX DETECTOR
PERFORMANCE SPECIFICATION
DESCREPTION/
URS-ID REQUIREMENTS
SPECIFICATIONS
Optical zeroing via set screw
Optics temperature
5 °C above ambient to 55 °C
control
Volume: 8 µL Maximum pressure: 5 bar (0.5 MPa)
Sample cell
Maximum flow rate: 5 mL/min
Valves Automatic purge and automatic solvent recycle
Inlet port to sample cell 62 µL,
Volumes
inlet port to outlet port 590 µL
Liquid contact materials 316 stainless steel, PTFE and quartz glass
pH range 2.3 – 9.5
Performance Short term noise: <±1.25·10-9 RIU
specifications Drift: <200·10-9 RIU/hr
Time programmable
polarity, peak width
parameters
Maximum data rate 74 Hz
Detector zero automatic zero before analysis
Lab Advisor B.02.07 or above
Instrument Control
LC and CE Drivers A.02.12 or above
Local control Agilent Instant Pilot (G4208A)
Recorder/integrator: 100 mV or 1 V,
Analog outputs
output range selectable, one output
LAN, controller-area network (CAN), ERI: ready,
Communications
start, stop and shut-down signals
Steril-Gene Life Sciences (P) Ltd.,
Puducherry
Analytical Research and Development
USER REQUIREMENT SPECIFICATION FOR
TITLE
REFRACTIVE INDEX DETECTOR
DESCREPTION/
URS-ID REQUIREMENTS
SPECIFICATIONS
Extensive diagnostics, error detection and display,
leak detection, safe leak handling, leak output signal
Safety and maintenance
for shutdown of pumping system. Low voltages in
major maintenance areas.
Early maintenance feedback (EMF) for continuous
tracking of instrument usage with user-selectable
GLP features limits and feedback messages. Electronic records of
maintenance and errors. Automated operational
qualification/performance verification (OQ/PV).
Housing All materials recyclable.
10.0 DELIVERY
To be delivered at the following site address,
Steril-Gene Life Sciences (P) Ltd.,
No.45, Mangalam main road,
Mangalam village, Villianur Commune,
Puducherry- 605 110
11.0 ABBREVIATIONS
12.0 REFERENCES
12.1 Standard Operating Procedure “Equipment Qualification” QA/124
12.2 EU Annexure 11.
12.3 21 CFR part 11 and sub parts.
13.0 ATTACHMENT
13.1 Specification of Agilent 1260 Infinity II Refractive Index Detector (G7162A).
01 01 New URS