|
Stability Chambers
Photostability Chamber
B.O.D Cooling Incubator
Pharma Refrigerators
Bacteriological Incubator
Plant Growth Chambers
Deep Freezer
Automatic Ice Flaker
Basket Centrifuge
Laboratory Centrifuge
Vacuum Oven
Laboratory Oven
Water Jacketed Oven
Hot Air Drying Oven
Ultrasonic Bath
Water Bath
Ultrasonic Emulsifier
Cryostat
Oil Bath
Constant Temperature Bath
Constant Temperature Bath with Agitator
Magnetic Stirrer Bath
Double Deck Incubator Shaker
Orbit Incubator Shaker
Orbital / Rotary Shaker
UV- Cabinet
Muffle Furnace
Vertical Dehumidifier
Industrial Flocculator
| |
Stability test 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.
- 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 are available 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 |
: ± 2°C. |
| |
|
Humidity Range |
: 40% to 95% |
Accuracy |
: ± 2% RH |
Humidity Uniformity |
: ± 3% RH |
| |
|
Power supply |
: 1 Phase, 230V ± 10% AC, 50 Hz.
OR 3 Phase, 440V. |
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.
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 hermetically sealed compressor.
Internal & External dimension :
|
|
