Photostability Chamber with Humidity and Temperature Control
Model No JRIC – 11C
» Specification
Designed specifically to meet ICH and FDA requirements for Photo Stability testing. Near UV and visible light testing is performed simultaneously. Calibrating 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 and humidity 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 to achieve ICH recommendation of 200W-hr/m2)
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VIS intensities: 12 lux(requires about 100hrs to achieve ICH recommendation of 1.2million lux-hr)
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Temperature range: 15.0°C to 40.0°C. Accuracy / Uniformity: ±0.1°C/±1°C
a) Distilled water OR DM water continuous supply with tap for boiler input of ½” BSP at 3 feet height.
b) 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.
c) Stabilized input voltage of 230V AC 20 Amps. Use of servo controlled stabilizer is recommended.
d) Water drain line with ½” nozzle to be provided at floor level.
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 in kgs
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) Digital light indicator (Lux meter with UV Indication)
b) Controller with printer interface to connect to EPSON Dot matrix line printer. Date, time and temperature can be printed whereas print interval can be set between 1 to 99 minutes. (Not supplied with printer)
c) PC interface for above controller with software on CD & hardware or software with 21 CFR Part 11 features
d) Imported RH sensor European make Rotronic Switzerland for higher accuracy
e) Standby humidity system (except for 52 and 120 liters)
f) Standby refrigeration system (except for 52 and 120 liters)
g) Data logger: 4 point temp. Data logger with sensors placed at specific points in chamber with printer interface and memory
h) 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 and humidity 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.
