Detailed Product Description

Stability Chambers are designed to carry out stability and shelf life test on drug and drugs substance according to ICH / WHO / FDA guidelines.

Salient Features :

• Double walled Construction with regular and GMP models.
• 80mm thick PUF insulation lagged in-between the walls to prevent loss of conditions.
• The chamber has two doors, inner full view glass door and outer metallic door with positive locking.
• A port hole of 50mm dia is provided on the side wall for inserting calibration transmitter.
• A well balanced CFC-free bypass ducting refrigeration system with eco-friendly refrigerant.
• Easily replaceable air tubular heater to heat the chamber.
• Low pressure water boiler & water reservoir with float valve & water level switch.
• Non-condensing water vapours injected into the chamber for humidification.
• Suitable dehumidification system by refrigeration method to maintain low humidity is provided within the prescribed accuracy.
• Dynamically balanced chamber circulatory system.
• Microprocessor based 2 channel multifunctional PID Temperature / Humidity (RH) controller used for processes requiring simultaneous control of temperature and % RH using capacitor type transmitter as RH sensor.
• The controller provides independent control output in the form of DC pulses for external solid state relays to control air heater, compressor and boiler heater.
• Separate display for Temperature, Humidity Set point and process values & real time clock.
• Easy front panel keyboard programmable.
• Temperature & RH configuration
      25?C / 60% RH.
      25?C / 40% RH.
      30?C / 65% RH.
      40?C / 75% RH.
      40?C / 25% RH.
• Capacity : 200 / 400 / 800 & 1000 Litres

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.
• Validating products to GAMP guidelines.
• Recorded files are in binary, compressed and checksumed format.
• Protection of records to enable their accurate and ready retrieval.
• Each user can have individual password protected user accounts.
• Secure computer generated, time stamped runtime audit trail of batch stop/start, alarm acknowledgements, logins, signature details, configuration changes.
• Multi batch recording.
• Standard networking via Ethernet.
• Report generation via Excel Add-in option.

Tamper proof Electronic Records

• Process Values and Audit Trails. (Alarms, Events, Electronic Signatures)
• Date and Time stamped.
• Time Synchronisation.
• Viewable in human readable format.
• Export conversion facility to Excel.

Electronic Signature

• User actions with signing and authorization.
• Unique signatures required.
• Automatic Log-off.
• Minimum length password.
• Access control according to authority level.