| Stability Chambers Lab Model
Walk-in Type
Walk-in Stability chambers are especially built to pass FDA and ICH Q1A compliance standards and have a reputation for reliability, quality and performance. Exceed FDA / ICH guidelines for long term, Intermediate and Accelerated Stability studies.
- Construction as per cGMP regulations
- Pre-engineered, Pre-fabricated modular panels with 80mm ‘PUF’ insulation with easy-to-assemble panels on site.
- Inside coating of floor is of stainless steel sheet 16 SWG thick, pressed, non-slip.
- Fastenings are cam locks for easy assembly and possible disassembly.
- Metallic door with double pane glass viewing window, hinged with positive locking.
- Stainless steel Racks with perforated trays .
- Consisting of refrigeration, air handling, humidification, dehumidification,
temperature/humidity controlling
- Microprocessor based 2 channel multifunctional PID Temperature / Humidity
( RH) controller for simultaneous control of temperature and % RH. OR
PLC based system for chamber control and auto changeover of standby system with touch screen display.
- Printer interface & PC interface for data storage
- Standard networking via Ethernet.
- Standard temperature & RH configuration.
25°C / 60% RH
30°C / 65% RH
40°C / 75% RH
- Specially designed chambers to carry out stability studies at low temperature and low humidity conditions such as
25°C / 40% RH,
40°C / 25% RH,
30°C / 35% RH,
40°C / 15% RH,
55°C / 20% RH and
55°C / 75% RH.
Data Acquisition system complying to US FDA 21 CFR Part 11
- Data records & process control systems have Electronic Signature & Electronic Record capability. The controllers have a lockout feature that permits changes through a 21CFR Part11 compliant operator station, thus providing the necessary audit trail.
- Mean Kinetic Temperature value.
- Password security for log in and door operations.
- Operators need to enter user name and password before taking any action.
- Report search option using date and sample name.
- Secure computer generated, time stamped runtime audit trail of batch stop/start, alarm acknowledgements, logins, signature details, configuration changes.
- User actions with signing and authorization.
- Access control according to authority level.
- Export conversion facility to Excel.
Temperature Range |
: 20°C to 60°C |
Accuracy |
: ± 0.2°C |
| Temperature uniformity |
: ± 1 °C. |
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Humidity Range |
: 40% to 95% |
Accuracy |
: ± 2% RH |
Humidity Uniformity |
: ± 3% RH |
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Power supply |
: 3 Phase, 440V AC, 50 Hz
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Temperature and RH Data Logger :
8 channel (4 temperatures + 4 humidity) or 16 channel
(8 temperature + 8 humidity), calibrated data logger to print date, time, temperature and humidity set and process values for mapping and auto validation. Features like printer and PC interfacing provided.
Standby Systems:
Standby refrigeration, humidity and RH sensor
Mobile Alert :
- Different Alarm indication through Mobile SMS Alert
(from single to multi user)
- Process value indication through Mobile SMS Alert
(from single to multi user)
Validation :
DQ/ FAT /IQ / OQ / PQ documentation with test and calibration certificate.
Safety features :
- Audio alarm provided to signal variation in temperature and relative humidity.
- Water level alarm & indicating device
- Safety digital temperature controller.
- Dedicated safety system to shut off the Boiler heater and air heater in case of over shoot of temperature by giving Audio visual alarm.
- In built over load protector provided for hermetic sealed compressor.
- Door can be unlocked from inside. Alarm switch and intercom connection provided inside the chamber for use in emergency.
Internal & External dimension :
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