Product Description

Whether your testing is for R&D, clinical trials or ongoing stability, the “TEMPO” stability chamber provide a stable temperature & humidity condition environment for worry-free operations with a control system that is easy to operate. “TEMPO” make stability chamber is designed as per ICH guidelines and are manufactured to comply with requirements in the industries. Stability testing is an integral part of formulation development. It helps to generate information, which permits well-considered proposals to be made for the shelf life of drug substances and products and recommended storage conditions.

The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, and to establish a re-test period for the drug substance or product under recommended storage conditions. Hence, the pharmaceutical stability chamber serves as an important quality attribute for the product.

• Temperature range               –     20°C to 60°C
• Temperature accuracy         –    ±0.2°C
• Temperature uniformity     –     ±1°C
• Humidity Range                   –     40% Rh to 90% Rh
• Humidity Accuracy              –     ±2%Rh
• Humidity Uniformity          –     ±3%Rh

Construction

Double-walled construction with backside triple-walled 3” thick PUF insulation ensures stable temperature with humidity & reduced energy consumption. Motorized Blower is fitted at the backside of the chamber.

The unit is provided with an adjustable stainless steel rod mesh tray. The equipment is mounted on caster wheels for easy movement.

Technical Specification

Controlling System

Two separate imported microprocessors based autotune PID controller with CE mark & dual display of set value & process value for temperature & humidity with direct %RH.

Air Circulation

The motorized blower at the backside of the chamber develops a unique air ow system which ensures max. uniform temperature & humidity condition inside the chamber.

Heating System

High-quality U shape S.S. tubular heater is used for better heating.

Humidity System

Steam injection system (Non-condensing type) & reservoir tank with water level arrangement with indicator.

Refrigeration System

CFC Free hermetically sealed Emerson Copeland make compressor for better cooling with R134 A (Eco Friendly) refrigerant with a time delay to safeguard compressor system.

Features

50 mm validation porthole with silicon rubber seal to insert sensors for validation. Full view observation Acrylic door with a gasket to observe the sample inside the chamber. Interior illumination for working area.
Specially designed stainless steel rod trays ensure uniform temperature distribution.

Safety Features

Additional safety thermostat to cut of dry heater supply in case temperature of overshoot. Float switch to cut off the wet heater supply in case of low water level. Audio & visual alarm. Compressor ON delay timer (2 min.) to safeguard the compressor.  Inbuilt overload protector provided for a hermetically sealed compressor.

Optional Features

• PLC for auto change over for standby refrigeration system with HMI
• CFR 21 part 11 compliance software for PLC with RS 485 or ethernet communication
• Stand by refrigeration and humidity system
• Data logger
• CFR 21 part 11 compliance software for data logger
• Data scanner complete with sensor
• SMS mobile alert system
• Door access security system
• Safety digital temperature controller
• Timer