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Stability Test Chambers

Climate Chambers for Stability Tests of Pharmaceutical Products

When testing the stability of drugs according to the guidelines ICH (International Conference on Harmonization)products must be stored under defined climatic conditions.
The test systems VP 280, VP 600, VP 1300 and VP 2000 were specially developed for use in laboratories and supplement the spacious walk-in chambers.

Features

  • The interior fittings are entirely made of stainless steel offering a storage area of 0.7m2 (VP 280), 2.07m2 (VP 600), 4.14m2 (VP 1300) and 6.21m2
    (VP 2000) on 2, 6, 12 or 18 loose shelves which are supplied as a standard feature.
  • The working range of the cabinets easily meets the requirements of the ICH Guideline Q1A.
  • The cabinets also permit the implementation of tests with other specifications in the performance range of the respective system.
  • Controlling of temperature and humidity is performed with highly precise sensors in combination with a specially designed control unit.

The control system responds quickly in order to correct set-point variations caused by

  • the influence of the cabinet’s contents (absorption or emission of water vapour by the test specimens or their packaging)
  • external influences (e. g. laboratory temperature, opening of door)

Application

The International Conference on Harmonization, comprising councils representing the pharmaceutical industry, as well as scientists and authorities, defines the demands on functionality, performance and documentation for stability tests in the pharmaceutical industry in its ICH guidelines. Europe, Japan and the USA agreed to common stability tests.

The objective of these tests is to gather information in order to make recommendations regarding the stability of substances or pharmaceuticals. The ultimate goal is to verify the stability of chemical, microbiological and physical characteristics after exposure to temperature and humidity over a defined period.

Standard Version

  • Digital measuring and control system Simpac* with 3,5" TFT-colour touch panel
  • Ethernet interface
  • Lockable doors
  • Password protected control panel
  • Door contact switch
  • stackabel (VP 280)
  • 6 feet (VP 280) or 4 castors, 2 of which with brakes (VP 600, 1300, 2000)
  • Water tank, 13 l (VP 280) or 19 l (VP 600, 1300, 2000) with automatic and manual water supply of demineralised humidification water
  • Air-cooled refrigeration unit with low noise emission
  • Patented vapour humidification system (Sterile Steam System)

Options

  • Simpati* Pharma
  • Networking (RS 485 interface)
  • Serial interface RS 232
  • Registration of temperature and humidity
  • Independent sensor for temperature and humidity
  • Acoustic and optical warning signal
  • Water-cooled refrigeration unit
  • Glass door, heated (VP 600, 1300 and 2000)
  • Feet separately adjustable in height
  • Additional shelves
  • Additional entry ports
  • Height-adjustable feet (VP 600, 1300 and 2000)
  • Qualification documentation for Pharma test system and Simpati Pharma software
  • Special voltage
  • Analogue outputs
  • Qualification on site
  • Calibration on site, also DAkkS accreditation

Contact

In case of further questions please call us (+49 7433 303-0) or use the following form.

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