Photostability Chamber

Photostability Chambers are developed according to the ICH 1Qb guidelines keeping in mind that light testing is an integral part of the stress testing. The chambers closely monitor temperature, Humidity (optional) and light intensity on the drug and drug substance.

The chambers are provided with a glass door for sample viewing & quick retrieval. They are connected through Ethernet to state-of-the-art 21 CFR Part 11 ready software that provide tools for viewing, trending, alarm management, audit trails, MKT & many other such features so as to comply with regulatory guidelines.

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Standard Features

This unit has double walled chamber, with PUF insulation.

Interior is made of Stainless Steel & Exterior is either made of Mild Steel finished with powder coating or Stainless Steel.

Fluorescent Tubes for day light effect and UV tubes for ultra violet ray in accordance to the ICH guidelines requirement of a lighting energy for 1.2 mil lux hours and UV-A light for 200 watt hours/m2

Inside full length observation glass door with secure gasket

The unit has outside metal door with gasket & lock.

The unit is provided with perforated Stainless Steel trays with adjustable height.

Forced air circulation for uniform temperature and Humidity.

PU wheels for easy move ability.

Heating System

Long lasting stainless steel tubular heaters with S.S. fins.

Cooling System

CFC free, the cooling system consists of hermitically sealed compressor coupled with evaporation coil and condenser, safe guarded by time delay circuit.

Sensor

PT-100 sensor used for measurement.

Temperature in degree Celsius with 0.1°C resolution.

Control System

PLC based control system with fast Ethernet communication.

4.3” color touch screen display

Temperature Range

  • 20°C to 60°C
  • Accuracy: ±0.2°C
  • Uniformity: ±1°C

Safety

UV light will be switched OFF when the door is open.

Unit is provided with safety devices for high and low temperature in case of malfunction.

Alarms

Automatic switch off of UV and fluorescent light when the test is over giving alarm.

Audio and Visual alarms are generated for temperature variation, utility failure.

Optional Accessories

  • SDMS Web based application for Alphatech Make Multiple Equipments
  • Mobile Alert System.
  • Door Access System.
  • Remote Alarm system

The unit works on 230 Volts AC and 50HZ mains supply

Note:

Note: Photostability Chamber with Humidity option also available.