INSTALLATION, OPERATIONAL & PERFORMANCE

QUALIFICATION

FOR

NAME: STABILITY CHAMBER

MAKE: OCEAN LIFE SCIENCE CORPORATION

TYPE: VERTICAL

MODEL: OLSC-103H-12

SERIAL NO: OL2303

Prepared By: Mukeem Ahmed Date:

Prepared By: Mukeem Checked & Verified By: P.N. KARAN

Ahmed

Date: Date:
 CONTENT

 System Description

 Design qualification

 Installation qualification

 Operational qualification

 Performance qualification

 Cleaning

 Maintenance program
 SYSTEM DESCRIPTION
 Vertical model.
 Robust construction outer chamber is made of Mild Steel duly pretreated & finished with powder coated paint
for lasting finish OR Stainless Steel Sheet (304 Grade).
 Inner chamber made of STAINLESS STEEL SHEET (316 Grade).
 Fitted with durable coaxial blower for forced air circulation at triple walled back to maintain temperature
uniformity in the chamber.
 Outer front double walled door is insulated and is fitted with magnetic tape for air tight closing for no
temperature loss, provided with lock and key arrangement.
 Illumination lamp is fitted inside the chamber for easy visibility.
 A full view inner Acrylic door enables inspection and monitoring of inner chamber specimens without
disturbing the process temperature.
 High grade Glass wool between outer and inner chamber for minimal thermal losses.
 Cooling is done by finned tube evaporator lie in the air circulation path by ISI marked hermetically sealed CFC
free Compressor & R-134 an eco friendly refrigerant.
 Heating elements are placed in the path of moving air duly insulated from the body.
 Inner chamber has ribs for placing the shelves at convenient levels. Supplied with adjustable high quality
stainless steel shelves for completely flexibility in use.
 Control panel having all controls and circuitry with Temperature controller cum Indicator Microprocessor
based with digital LED display for Set Value (SV) & Process Value (PV) to select any desired temperature
provided.
 Caster wheels with stopper mounted for easy portability. Supplied with cord and plug.
 Operating Voltage: 230 Volts AC (50 Hz).
 WHO-GMP, CE, ISO 9001, ISO 13485, ISO 14001 & OHSAS 18001 certified.
Technical specification:
 Approx. Volume (Ltr) : 350
 No. of Shelves (adjustable) : 3
 Temperature Range : 0°C to 60°C (Adjustable)
 Temperature Accuracy : ±0.5°C to ±1°C
 Humidity Range : 40% to 95% RH, ± 3%
 Controller : Microprocessor based safety PID controller with inbuilt thermostat
 Alarm : Safety alarm for temperature overshoot
 Display : Digital LED Display for Set Value (SV) and Process Value (PV)
 Relay : Solid state electronic relay with protective heat sink.
 Auto Tuning System : System is compatible with auto tuning system
 Air Circulation : By forced convection System
 Insulation : By Glass wool
 Operations : Nearly silent operation with ultra-low vibration
 Nominal voltage : 220-230 Volts, 50 Hz Single Phase
 Printing Facility : By Built in Mini Printer to record temperature.
 GSM System : Alarm sent to predefined Mobile Numbers
 Data Logger : 4 point temperature data logger with sensor placed at specific points at
internal chamber with memory backup for minimum 3 months.
 Regulated Voltage : By Suitable Voltage stabilizer
 DQ OF STABILITY CHAMBER

DQ: DESIGN QUALIFICATION

PURPOSE: - The purpose of the design qualification [DQ] is to ensure that the instrument
can be operated as expected

PARTICULARS (IN SWITCH ON CONDITION) REMARKS

Body is constructed of material as per specification :
Inner Chamber made of Stainless Steel 316 grade & Outer body made of mild OK
steel duly powder coated
Capacity of the instrument as per specification :- 350 liters OK
Forced air circulation assembly as per specification: For heating and cooling OK
Chamber illumination light arrangement OK
Inner Acrylic door for chamber visibility as per specification OK
Heating, cooling & Humidity setup OK
Flexibility to adjust shelve at convenient levels OK
Stainless steel shelves OK
Heavy duty castor wheels OK
Heavy duty Door with lock OK
Microprocessor based temperature controller with inbuilt thermostat OK
Safety alarm for temperature overshoot OK
Thermal printer for printing facility OK
Data logging through USB drive OK
GSM module System OK
Voltage stabilizer OK

Checked by:
 IQ OF STABILITY CHAMBER
IQ: INSTALLATION QUALIFICATION FOR STABILITY CHAMBER

PURPOSE:-

1) To have visual checking of the instruments for any damage during transportation

2) To check for all accessories of the instruments meeting the specifications.

3) To ascertain and approve that the adequate facilities shall be provided that meets the
requirement for the installation of the instruments

PARTICULARS REMARKS
Any breakage/Leakage in Stability Chamber :- No OK
Level /Balance of stability chamber :- Properly balanced OK
Power cables :- Fixed with the instruments OK
Any loose connection / fittings :- No OK
Rust if any :- No OK
Properly insulated :- Yes OK
Compressor & Fan motor properly fixed and checked :- Yes OK
Electric power supply 220-230V AC (single phase) Shall be available earthing must
OK
be proper before installation :- Yes
Inner acrylic door is fitted properly balanced :- Yes OK
Insulated double walled front door properly balanced and fitted
OK
:- Yes
Door lock with key and four castor wheels :- Yes OK
Control panel
Microprocessor based temp. controller :- Yes
Thermal Printer :- Yes
OK
USB port :- Yes
Main ON/OFF Switch :- Yes

Checked by:

OQ OF STABILITY CHAMBER
 OQ: OPERATIONAL QUALIFICATION

PURPOSE: - The purpose of the operation qualification [OQ] is to ensure that the instrument
can be operated as expected and described and further to established the
standard operating procedure [SOP]

PARTICULARS (IN SWITCH ON CONDITION) REMARKS

Power ON / OFF :- ON OK
LED display showing the initial positions of SV, PV, etc. as per the set
OK
values :- OK
Indicators and Switches :- OK OK
When we soft touch switch for Set/ ENT and Increment/Decrement key
OK
(as per instructions Working or Not) :- WORKING
Compressor & FAN :- WORKING OK
Digital temperature controller and Switches
Microprocessor based temp. controller :- WORKING
Thermal Printer :- WORKING OK
USB port :- WORKING
Main ON/OFF Switch :- WORKING

Checked by:
 PQ OF STABILITY CHAMBER
PQ: PERFORMANCE QUALIFICATION

PURPOSE: - The purpose of the performance qualification [PQ] is to ensure that the instrument can be
operated as expected and describe and further to establish the standard operating
procedure [SOP]

After cleaning the chamber & front door is closed, the instrument is switched ON and
display will ON. There are soft KEYS on the keypad provided for setting the required
parameters.

With the help of keys/buttons are available Press ENTER to start

By the following procedure provided, the following parameters are observed.

PARTICULARS REMARKS
Switching ON the Mains Press SET key to Change setting in set mode by Increment
OK
& Decrement key and Press enter to start process.
Digital display to see the parameter (Temp & Humidity) :- OK OK
Temperature reading of chamber :- OK OK
Humidity reading of chamber :- OK OK
Thermal printer :- OK OK
Data logging through USB Port :- OK OK
Mains ON/OFF switches :- OK OK
Observation:
Set points: 25°C – 60% Rh, 40°C – 75% Rh, 30°C – 65% Rh, 25°C – 40% Rh

1) For Temperature
At Temperature : 250C, Accuracy :- ±10C approx
At Temperature : 300C, Accuracy :- ±0.5 to ±1.00C approx
At Temperature : 400C, Accuracy :- ±0.5 to ±0.90C approx
OK
2) For HUMIDITY
At Humidity : 60% Rh, Accuracy :- ±5%
At Humidity : 75% Rh, Accuracy :- ±3%
At Humidity : 65% Rh, Accuracy :- ±3% to ±5%
At Humidity : 40% Rh, Accuracy :- ±5%
Note:- accuracy will be maintained within 40 min after achieving the set value
All the reports are verified by

Name Signature Date

 PREVENTIVE MEASURES PROTOCOL

1. Close Down Operation:

a) Switch 'OFF' the instrument from the panel, i.e. press 'POWER ‘key.
b) Switch 'OFF' the voltage stabilizer.
c) Switch 'OFF' the mains.

2. Cleaning Operation:
a) Wipe all the traces of organic solvent I water I moisture by tissue paper.
b) Clean all the dust from the working table by tissue paper.
c) Close the door/sash of the instrument.

3. Maintenance Program:
 When the instrument is under breakdown I maintenance I not functioning, put the tag stating 'OUT
OF ORDER' and inform to the instrument manufacturer I servicing person as per the requirement.
 After completion of repairing Servicing job, instrument should be checked for appropriate working
by the Q.C. Officer I Chemist.
 Engineer prepares the service report and Q. C. Department retains one copy of the report.
 Calibrate the instrument prior to use.

4. Records:
 Adequate records shall be maintained showing the calibration observation.
 Records of all maintenance shall be maintained.

5. Distribution: Q. C. I Q. A. I R. & D. I Production (D. P. I.)

The following information available:

Service information : Customer support Department

Contact :