These Stability chambers are designed as per ICH guidelines and are manufactured to comply with the requirements of cGMP in industries for stability and shelf life test on drugs and drug substances. The chambers have outer body of SS 304 (dull buff finish) and inner chamber of SS 316 (mirror finish). The chambers are equipped with capacitance type humidity sensor for direct display of humidity and temperature with user friendly Microprocessor control system for setting and control of run parameters. The use of RS-485 port & software greatly enhances the performance of the cabinets. PC interface allows the user to monitor the performance of number of cabinets even from a remote location. Windows based software allows the user to store & analyze the data obtained from various stability chambers / incubators & deep freezers within the lab. Reports are generated both in tabular & graphical formats. The security features incorporated in the software meets the requirements of 21 CFR part 11.
Salient Features:
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Digital display of temperature & humidity.
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Menu driven 10 program memory
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Safety thermostat to prevent over heating.
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Audio Visual alarm warnings of Temp. & RH variation and low water level.
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Built in safety circuit, which cuts off system & stops unit in case of malfunction of microprocessor.
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Non volatile memory for data storage up to 2500 records.
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Centronics interface for keeping hard copy of Temp., Humidity, Time & Date. RS-485 interface to transfer data to PC for further analysis.
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Adjustable print interval.
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High voltage safety cutoff for unit protection.
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Validation protocol for IQ, OQ, PQ as per ICH guidelines.
Optional:
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RS-485 Interface to personal computer for multiple networking of chambers.
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Software Complying with 21CFR Part 11
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Chamber illumination with fluorescent or ultra violet lights.
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Cyclic timer for regulating illumination conditions.
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8 channel temperature/humidity data logger.
Technical Data
CHM-6S (GMP)
CHM-10S (GMP)
CHM-12S (GMP)
CHM-16S (GMP)
Internal Volume
170 LTRS
285 LTRS
340 LTRS
5O0 LTRS
No. ot Shelves
2
3
3
5
Int. Dimensions W x D x H (mm)
500 x 410 x 840
580 x 490 x 990
620 x 520 x 1020
700 X 600 x 1100
Ext .Dimensions W x D x H (mm)
620 x 670 x 1380
700 x 750 x 1530
740 x 780 x 1510
830 x 870 x 1770
Temperature Control
Microprocessor
Temperature Range
10ºC to 60ºC ± 1ºC
Humidity Range
40% to 95% ± 3%
Inner Chamber Material
Stainless steel 316 (AISI Grade, Non Corrosive, Non Magnetic)
Outer Body Material
Stainless steel 304 (AISI Grade, Non Corrosive, Non Magnetic)