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.
|Models||Capacity||Internal chamber||External dimension||Weight (Kg)||Maximum trays|
|Litres||dimension||W x D x H (mm)||can be|
|W x D x H (mm)||accommodated|
|WIL-195A||90||450 x 450 x 450||710 x 970 x 1070||125||2|
|WIL-195B||200||600 x 450 x 750||800 x 1000 x 1370||175||3|
|WIL-195C||400||600 x 600 x 1100||800 x 1140 x 1720||250||4|
|WIL-195D||800||800 x 750 x 1300||1000 x 1300 x 1930||315||8|
|WIL-195E||1000||800 x 800 x 1520||1000 x 1360 x 2150||355||10|