Company Name Page 1 of 6

Equipment Name Stability Chamber Effective Date:

Document No. Revision No.: 00

USER

REQUIREMENT

SPECIFICATION

OF

STABILITY CHAMBER
Company Name Page 2 of 6
Equipment Name Stability Chamber Effective Date:
Document No. Revision No.: 00

INDEX
1.0 OBJECTIVE:________________________________________________________________3
2.0 SCOPE:____________________________________________________________________3
2.1 BASIC OF SYSTEM:______________________________________________________________3
3.0 TEMPERATURE AND HUMIDITY RANGE:_____________________________________3
4.0 STAND-BY SYSTEMS:_______________________________________________________3
5.0 CONTROL SYSTEM:_________________________________________________________4
5.1 TEMPERATURE CONTROLLER:__________________________________________________4
5.2 HUMIDITY CONTROLLER:_______________________________________________________4
5.3 PC / PRINTER INTERFACE UNIT:_________________________________________________4
5.4 SAFETY CONTROLLER:_________________________________________________________4
5.5 SCANNER:______________________________________________________________________5
5.6 PLC:____________________________________________________________________________5
5.7 DOOR ACCESS SYSTEM:_________________________________________________________5
5.8 MOBILE ALERT SYSTEM:________________________________________________________5
5.9 CONTROL PANEL:_______________________________________________________________5
6.0 SAFETY FEATURES:________________________________________________________5
6.1 SAFETY CONTROLLER FOR LOW / HIGH TEMPERATURE AND HIGH HUMIDITY:__5
6.2 SAFETY THERMOSTAT:_________________________________________________________5
6.3 HUMIDITY SAFETY THERMOSTAT:______________________________________________5
6.4 WATER LEVEL SAFETY:_________________________________________________________6
6.5 COMPRESSOR SAFETY:_________________________________________________________6
6.6 ELECTRICAL SAFETY:__________________________________________________________6
7.0 OPTIONAL ACCESSORIES:__________________________________________________6
7.1 SOFTWARE:____________________________________________________________________6
7.2 WATER TANK:__________________________________________________________________6
7.3 PRINTER:_______________________________________________________________________6
8.0 VALIDATION DOCUMENTATION:____________________________________________6
9.0 APPROVAL:________________________________________________________________6
Company Name Page 3 of 6
Equipment Name Stability Chamber Effective Date:
Document No. Revision No.: 00

1.0 OBJECTIVE:
This document is to identify the user requirements of the Stability Chamber. This is a basic document for
the Stability system and it will be used for further life cycle of project. The requirements specified in this
document will be verified in performance qualification tests.

The user requirement for procurement of Stability Chamber capable of maintaining desired temperature
and humidity and accommodating required number of samples with a capacity of approximately

 1000 Ltrs : 

2.0 SCOPE:
The scope of this document is applicable to the Stability Chamber with the following conditions:
25°C & 60% RH Condition
30°C & 65% RH Condition
40°C & 75% RH Condition
___°C & ___% RH Condition
2.1 BASIC OF SYSTEM:

 Capacity : 1000 Ltrs

 Inner Size (W X D X H) : 800 W x 800 D x 1570 H mm
 Material of Construction
GMP Model : Inside S.S. 304
Outside S.S 304 
Standard Model : Inside S.S. 304 N.A.
Outside MS Powder coated
 Total No. of Trays : 2 Nos
 Environment condition temperature and humidity specified requirement as per ICH guideline
 Running condition : Temperature ____°C & Humidity ___% RH

3.0 TEMPERATURE AND HUMIDITY RANGE:

Range : Temperature 20°C to 60°C
& Humidity 40% RH to 98% RH
Accuracy : Temperature + /- 0.2°C & Humidity + /- 2% RH
Uniformity : Temperature + /- 2°C & Humidity + /- 3% RH
4.0 STAND-BY SYSTEMS:
a) Humidity √

A standby humidity system which should work in case of failure of the regular humidity system
b) Refrigeration √
A standby refrigeration system, which should work in case of failure of the regular refrigeration system.
Company Name Page 4 of 6
Equipment Name Stability Chamber Effective Date:
Document No. Revision No.: 00

5.0 CONTROL SYSTEM:

 Temperature Controller √

 Humidity Controller √

 PC / Printer Interface Unit √

 Safety Controller √

 Scanner √

 PLC √

 Door Access System √

 Mobile Alert System N.A.

 Control Panel √

5.1 TEMPERATURE CONTROLLER: √

o Microprocessor based PID Temperature controller.

o Access control for setting parameters in controllers.
o Low / High alarm setting

5.2 HUMIDITY CONTROLLER: √

o Microprocessor based PID Humidity controller.

o Access control for setting parameters in controllers.
o Low / High alarm setting

5.3 PC / PRINTER INTERFACE UNIT: √

o Settable print interval as per requirement.

o Real time clock in built
o Capable for interface with pc

5.4 SAFETY CONTROLLER: √

o Temperature Range : -5 to 70 °C.
o Humidity Range: 10 to 99 %RH.
o Alarm range for Temperature 2 to 5 Deg C
o Alarm range for Humidity 2 to 9.9 %RH.
Company Name Page 5 of 6
Equipment Name Stability Chamber Effective Date:
Document No. Revision No.: 00

5.5 SCANNER: √

o Data logger / scanner 8 channel (4-point temperature and 4-point RH) with a provision
for increase in up to 16 channels. Microprocessor based Datalogger for continuous
monitoring of temperature and humidity.
o Data logger with printer port and computer interface port.
o Adjustable period for scanning of channels.

5.6 PLC: √

o Automatic change over of refrigeration system

o Automatic change over of humidity system

5.7 DOOR ACCESS SYSTEM: √

o Accept proximity card 24 hrs access suitable for automatic and manual door.
o Facility available to authorized entry to selected card holders
o Facility to delete the card
o No restriction on number of card holder
o Chamber security system with access door security with multilevel password

5.8 MOBILE ALERT SYSTEM: N.A.

o SMS sending facility to three users.

o Facility available to reprogrammed user number with the help of SMS software.
o Upto 8 no of chambers can be connected to one unit.

5.9 CONTROL PANEL: √

o Printer port : Position side mounting
o Electrical Component : Solid State Relay, Contactor, MCB’s, Switch

6.0 SAFETY FEATURES:

Control system should take care for avoiding overshooting or under shooting of control parameter in worst
case.
6.1 SAFETY CONTROLLER FOR LOW / HIGH TEMPERATURE AND HIGH HUMIDITY:
There should be a cutoff in case of overshoot or undershoot of temperature with audio visual alarm
through PLC and overshoot of humidity with audio visual alarm.

6.2 SAFETY THERMOSTAT:

There should be provision of safety relay which will cut off the main contactor through PLC in case of
variation in the set conditions

6.3 HUMIDITY SAFETY THERMOSTAT:

There should be provision of safety relay which will cut off the running humidity system through PLC in
case of temperature increased in the evaporative tray.
Company Name Page 6 of 6
Equipment Name Stability Chamber Effective Date:
Document No. Revision No.: 00

6.4 WATER LEVEL SAFETY:

There should be provision for magnetic float switch in the reservoir tank.

6.5 COMPRESSOR SAFETY:

There should be provision for over load relay and time delay.

6.6 ELECTRICAL SAFETY:

The wiring should be as per the IS code and it should be with various MCB’s for safety purpose.
7.0 OPTIONAL ACCESSORIES:
7.1 SOFTWARE: √

o CFR 21 Part 11 compliance window based communication software for data management.
o Complete with RS 485 multi dropping to monitor multiple chamber to one

7.2 WATER TANK: N.A.

o Water storage S.S tank of 30 ltrs capacity with 2 tap connection, lid and stand

7.3 PRINTER: N.A.

o 80. Col Dot matrix printer along with S.S stand

8.0 VALIDATION DOCUMENTATION:

o Design Qualification
o Installation Qualification
o Operational Qualification
o Performance Qualification
o Test and Calibration Certificates.
o Preventive Maintenance Procedure
o Standard Operating Procedure

9.0 APPROVAL:
Activity Name Designation Signature / Date

Prepared By

Reviewed By

Approved By