Stability Test Chambers

Our LABTOP ® Stability Test Chambers are meant for conducting stability and shelf life studies on various types of drugs or medicines. These chambers have found their extensive usage in the fields of seed testing, biological studies, and in pharmaceutical industry. The design of our stability test chambers is in compliance with the guidelines of various international standardization organizations such as ICH, WHO, and USFDA. These stability test chambers are manufactured by us in various sizes.

Stability Test Chambers Features

• Precise temperature and humidity control through the use of CE approved PID controller (Auto tunning type) based on micro controller.
• A digital meter for clearly displaying the direct reading of the percentage of relative humidity inside the chamber. This reading is provided by an electronic capacitance type sensor.
• R-134a environment-friendly refrigeration system with CFC free compressor and time delay feature.
• Have a proper PC interface with installed windows based communication software.
• Programmable timer which is based on micro controller for managing the chamber illumination.
• Foamed-in-place PUF insulation ensures stability of temperature and energy saving.
• Option of audiovisual alarm in case of temperature deviation from the preset value.

Cabinet Construction and Refrigeration System
A high density CFC free polyurethane foam is used to insulate the cabinet of our LABTOP stability test chambers. The internal body of this chamber is made of 304 SS grade mirror finish stainless steel (0.8mm thick) while the external body is fabricated from powder coated mild steel (1.0mm thick). The door of this stability test chamber possesses a keyed lock having a magnetic gasket. The cooling inside this chamber is intensified by a hermetically sealed high quality compressor.

Optional Accessories
Stand by Refrigeration System A readily available standby or backup refrigeration system which can be of great help in case of regular system failure. This system is composed of compressor, condensers, evaporator, and other vital accessories.

Safety controller : A dedicated safety controller equipped with a specialized sensor which gives an audiovisual alarm and then switches off the power supply in case of temperature overshoot and undershoot.

Printer Interface : A facility to store and print records on the printer with set values, process values, date and time at a flexible print time interval. This interface also allows data storage for online and offline printing, appropriate for dot matrix 80 columns printer.

Software :A web-based communication software for data management which is CFR 21 Part 11 compliant. This software also has RS 485 multi dropping to monitor multiple chambers.

PC Interface and data management : Remote monitoring and data logging for controlling the chamber is allowed by the PC interface. It also works as a web-based software providing tabular and graphical style reports.

Temperature & Humidity Sensor : Wick, cup, and water are avoided by this electronic capacitance type temperature and humidity sensor.

PLC system : It is a programmable logic controller (PLC) which is meant for automating the task of changeover of standby systems and miscellaneous event management tasks. It possesses a 3.7” touch screen LCD enabled security lock, which helps in preventing any kind of unauthorized tampering.

US FDA 21 CFR Part 11 Features

• Ease of modifying and monitoring control parameters.
• US FDA 21 CFR Part 11 compliant.
• Multiple access levels offering full control over them.
• Multiple users with individualized username and password.
• Database backup, security, and restoration facility.
• Online and offline trends
• Chamber wise report/trend generation and printing facility. The report so created can be exported to various file formats (like PDF, Excel, etc.) with convenience.
• Stored data can be analyzed.
• Alarm acknowledgment with user comments.
• Auto account logout and lockout security feature.
• ccess control with exclusive username and password.
• Critical parameters like the alphanumeric password can only be changed through reconfirmation of individual username and password.
• Password aging complying US FDA 21 CFR Part 11 Date and Time stamp audit trails user equipments.

Documentation
For GMP complaint models LABTOP offers IQ, OQ, PQ and DQ validation with documentation, reports, calibration and test certificates

Calibration
The equipment is calibrated with the use of master calibrator, which is approved by the Government of India recognized Electronics Regional Testing Laboratory (ERTL) in traceable reference with the U.K's, National Physical Laboratory (NPL).