STABILITY CHAMBERS (WALK – IN TYPE)

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
Litres
Internal chamber
dimension
W x D x H (mm)
External dimension
W x D x H (mm)
Maximum trays
can be
accommodated
WIL-196A 8000 2000 x 2000 x 2000 2178 x 2973 x 2205 24
WIL-196B 12000 2400 x 2400 x 2000 2578 x 3373 x 2205 28
WIL-196C 15500 2500 x 3000 x 2000 2680 x 3975 x 2205 36