URS Microscope

BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD.
R.S. No. 578, Near Effluent Channel Road, Vill.: LUNA, Tal.: Padra, Dist.: Vadodara - 391440
USER REQUIREMENT SPECIFICATION
TITLE USER REQUIREMENT SPECIFICATION FOR MICROSCOPE
URS NO. BDR/URS/72 Page No: - Page 1 of 7
Name of equipment : Microscope

Department : QC Microbiology
Area : Media Preparation Room
URS number : BDR/URS/72
No. of pages (Including Cover Page) : 01 to 07

1.0 APPROVAL:
SIGNATORIES
Prepared By
Department Name Designation Signature Date
Reviewed and Approved By

Department Name Designation Signature Date
Accepted By Vendor
The User requirement specification has been discussed and agreed upon. We hereby declare that we
will supply the equipment / system as per above laid down specification.
Name of Vendor Signature Date
2.0 SCOPE OF URS:

The User Requirements Specification (URS) document is for the purpose of specifying the user
requirements for a Microscope used to observe the grams’ staining slides for microbes and mounted
fungal slides.
Based on the URS, the supplier shall provide design qualification / functional specification which shall
be duly approved by BDR Pharmaceuticals International Pvt Ltd. as well as supplier.
3.0 BRIEF OVERVIEW:
Microscope should provide sufficient magnification of the object to be observed under microscope with
clarity and shall support the highest requirements for safety, efficiency, quality assurance and ease of
compliance.
4.0 REQUIREMENT DETAILS:
4.1 Name of Equipment/ System: Microscope

4.2 Purpose of Equipment : This Microscope is to be used for the observation of the
gram’s staining slide of microorganisms and for the observation of mounted microorganism and
motility of microorganisms in Quality control microbiology laboratory.
4.3 Type: Binocular microscope along with camera for the photograph of the object observed
under microscope.
4.4 Component Details/Technical specification:

Sr. No. Part Specification
4.4.1 Microscope Coarse/Fine adjustment on the right side
frame Fine focus graduated knob
Stage movement (X Y direction)
Quadruple revolving nosepiece
Plane stage approx. 120 X132 mm
Right handed mechanical stage
Condenser with diaphragm
Blue filter
Universal Power supply (100V to 240V) for 6V
illuminator
8cc immersion oil
Dust cover
Mirror unit
4.4.12 Observation Binocular observation tube (Indication 45°), inter pupillary
tube distance adjustment range 53-75 mm), Diopter adjustment

on the left.
4.4.13 Objectives 5 X anti-fungus

10 X anti-fungus
45 X spring anti-fungus
100 X spring anti-fungus, oil immersion
4.4.17 Eyepiece 10 X (anti-fungus) X2
4.4.18 Lamp 6V 20W Halogen Lamp x02
4.4.19 Power cord NA
4.4.20 Camera 3 or 5 MP
Required Resolution which is enough for better clarity and
to distinguish the different structures of microorganisms
under microscope.
4.4.22 Software Operating system to save the analytical data and to take
print out
Image format in JPG/PDF format
4.4.24 Electrical PC/Laptop-USB-2
interface Power supply 5V DC via USB
4.4.25 Operating -10 ° C to 50 ° C
temperature
4.4.26 Operating 30-80 % RH
humidity
4.4.27 Printing and Should be able to save and print the analytical data
storage of data
4.5 Process Control Requirement:
Sr. No. Component(s) / Feature(s) Required Description

( Yes / No ) ( as applicable )
4.5.1 Internal calibration NO Not Applicable as
measuring of object is
not to be done
4.5.2 Earthing Yes ---------
4.6 Functional requirement:

Clear and distinguished microbial structural morphology under microscope as well as in
image print out.
4.7 Mode of operation:

Manual or automatic
4.8 Power Failure/Recovery: Yes
4.9 Safety Features:
Sr. Component(s) / Required Description

No. Feature(s) ( Yes / No ) ( as applicable )
4.9.1 Emergency Stop Yes ON/Off Push Button
4.9.2 Electrical Yes Non Flame proof
Protection
( Flame Proof /
Non Flame Proof )
4.9.3 Alarms and NO Not Applicable
Warnings
4.9.4 Earthing Yes All metal parts are properly grounded to
lead any electrostatic charge to the ground
system.
5.0 UTILITY REQUIREMENTS:
Sr No. Type Specification Remarks

5.1 Electrical 230V-240V --
6.0 SUPPORTS FROM VENDOR
6.1 Development:
The Supplier shall provide a Project Representative for the project to provide a single
communication point with the User.
6.2 Maintenance:
The expected hardware and software maintenance support including ease of maintenance,
expansion capability (software only), likely enhancements (software only) expected lifetime
and long-term support are described below.
System shall be maintained on a schedule as indicated by the supplier. Supplier is to provide

(at minimum) the following maintenance instructions.
Maintenance activities for all sub-systems provided (Maintenance and operation manuals of
vendor equipment)
A lubrication list and recommended lubrication schedule.
A comprehensive recommended maintenance (regular recommended inspection intervals, wear

points, recommended spare parts list).
Supplier shall supply three copies of Operation, Installation, Maintenance and de-
commissioning manuals.
6.3 Testing:
FAT/SAT
In order to verify that the equipment / system delivered as per purchase order, the SAT (Site
Acceptance Test) may be followed.
6.4 Documentation:
Installation, operation, and maintenance instruction documentation for the system.
The Supplier shall provide documentation reflecting “as-built” condition with final delivery.
All documents shall be in the language of the destination country (English) and supplied with
hard copies and electronic versions supplied in the format identified for each document. The
documentation and format requirements for this project are listed below.
No. Title Required Description

( Yes / No ) ( as applicable )
I Material of Construction
Yes
( MOC) certificate of Contact parts
II Qualification document
Yes
(DQ / IQ, OQ)
III Operational and Maintenance Manual in
Yes
English language ( 3 set )
IV Spare parts list with Part No
Yes
V Component list with manufacturer list and Yes
address
VI Others
a Inspection at Vendors end Yes
b Technical Support Yes
6.5 Training:
User training shall consist of 2 hours of Operator training and 2 hours of Maintenance training.
The Supplier shall notify the User on preventative maintenance system improvement
availability on a regular basis.
7.0 Abbreviation
Abbreviation Definition
URS User Requirements Specification
MP Mega Pixel
SAT Site Acceptance Test
FAT Factory Acceptance Test
MOC Material of Construction
IQ Installation Qualification
OQ Operational Qualification
RH Relative Humidity
DC Direct Current
°C Degree Celsius
V Volt
mm millimeter
W Watt

URS Microscope

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BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD.

Name of equipment : Microscope

No. of pages (Including Cover Page) : 01 to 07

Reviewed and Approved By

2.0 SCOPE OF URS:

3.0 BRIEF OVERVIEW:

4.0 REQUIREMENT DETAILS:

4.1 Name of Equipment/ System: Microscope

4.4 Component Details/Technical specification:

tube distance adjustment range 53-75 mm), Diopter adjustment

4.4.13 Objectives 5 X anti-fungus

4.5 Process Control Requirement:

Sr. No. Component(s) / Feature(s) Required Description

4.6 Functional requirement:

4.7 Mode of operation:

4.8 Power Failure/Recovery: Yes

4.9 Safety Features:

Sr. Component(s) / Required Description

5.0 UTILITY REQUIREMENTS:

Sr No. Type Specification Remarks

6.0 SUPPORTS FROM VENDOR

System shall be maintained on a schedule as indicated by the supplier. Supplier is to provide

A lubrication list and recommended lubrication schedule.

A comprehensive recommended maintenance (regular recommended inspection intervals, wear

No. Title Required Description

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