STABILITY CHAMBERS (LAB MODEL)

• 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 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.