Designed specifically to meet ICH and FDA requirements for Photo Stability testing. Near UV and visible light testing is performed simultaneously. Calibrated Photon detectors measure lamp intensity on the product shelf. Lamp intensity (W/m2 or Lux) and exposure level (W-hr/m2 or Lux-hr) are conveniently displayed at eye level by a calibrated digital light meter. After a programmed exposure level is reached the lamps automatically shut-off. To enhance reliability, internal air temperature conditions are controlled throughout the photo stability test
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Lamp type: Fluorescent
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UVA intensities: 1.8 W/m2 (requires about 111hrs achieving ICH recommendation of 200W-hr/m2)
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VIS intensities: 12 Klux (requires about 100hrs achieving ICH recommendation of 1.2million lux-hr)
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Temperature range: 15.0°C to 40.0°C. Accuracy / Uniformity: ±0.5°C/±1°C
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Temperature display: Digital LED 3½ digit
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Control: Microprocessor based PID control. With Auto tune CE marked
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Temperature sensor: PT – 100
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Heating: ‘U’ shaped Nichrome wire heater in SS sheathing
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Cooling: CFC free Copeland make compressor utilizing R 134A eco friendly refrigerant, with condenser, motor and relay
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Air circulation: Flange motor with impeller/blower
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Construction: Double wall, with insulation, outer door key lockable, inner glass viewing door
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Chamber illumination: Fluorescent light with door switch
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Safety features
: High temperature safety cut off
: Electrical overload cutoff relay for compressor
: Time delay for compressor switch ON
: Electrical circuit breaker
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Feet: Castor wheels
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Trays: SS wire mesh heavy duty
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Electrical: 230V / 15A / 50 Hz
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Calibration certificate by ERTL – Mumbai with traceability to NPL – New Delhi
Pre Installation Mandatory Requirement :
(Guarantee void incase of non compliance)
We understand customer needs as well as aim at exceeding general expectation
Constantly strive to strengthen and sustain quality levels
36 years old organization with sound integrity and commitment
a) Room temperature around machine preferably at 25°C with air conditioning or a well ventilated room with exhaust fan. However surrounding temperature should not exceed 30°C
b) Stabilized input voltage of 230V AC 20 Amps. Use of servo controlled stabilizer is recommended
STD Model
GMP Model
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Outer cabinet mild steel powder coated
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Outer cabinet SS 304 grade dull matt finish
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Inner chamber stainless steel 304 grade
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Inner chamber stainless steel mirror finish
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With DQ, IQ, OQ documentation
Capacity
Internal Size
External Size
Shelves
Shpg Wt
Cu.ft
Liters
W x D x H cm
W x D x H cm
(SS)
4
120
45 x 45 x 60
65 x 114 x 130
2
200
8
200
60 x 60 x 60
79 x 121 x 130
2
240
12
324
60 x 60 x 90
79 x 121 x 165
3
250
16
450
60 x 60 x 125
79 x 121 x 199
4
265
21
600
60 x 60 x 155
79 x 121 x 247
5
295
28
800
80 x 80 x 125
99 x 141 x 199
5
325
34
1000
80 x 80 x 155
99 x 141 x 247
5
375
Optional Extras / Accessories
a) PLC based system: PLC with HMI 3.7” touch screen grey monitor with 21 CFR Part 11 features (OSLOG) software
b) Magnetic door lock feature
c) GSM system: alarms sent to predefined mobile numbers
d) HMI: 5.7” touch screen grey in lieu of 3.7”
e) Digital light indicator (Luxmeter with UV Indication)
f) Digital PID controller with printer interface to connect EPSON Dot matrix line printer. Print interval programmable, can print date, time, temperature
g) PC interface for above controller with software on CD & hardware or software with 21 CFR part 11 features
h) Data logger: 4 point temp. Data logger with sensors placed at specific points in chamber with printer interface and memory
i) PC interface for above controller with software on CD & hardware
Temperature Mapping
Photo Stability Chamber : Performance qualification with temperature and humidity mapping on site.
Temperature mapping consist of one cycle at any one temperature point for a 24 hours period. This is done to demonstrate the uniformity of temperature and humidity within the chamber is acceptable and that the samples within the chamber receive a uniform temperature and humidity condition.
Data is collected in printed format from up to eight different points ( i.e six temperature points and two humidity points ) within the chamber.
Temperature uniformity is considered acceptable if the deviation is less ±1ºC of set temperature. Humidity uniformity is considered acceptable if the deviation is within ±3% of set humidity.
Note: Every OSWORLD Photostability Chamber is validated prior to dispatch at the factory. Those customers who do not require on site mapping may request for FREE copy of factory mapping cycle data sheet.
