Walk-in test chambers for stability testing according to ICH Guideline Q1A

The extremely accurate and reliable stability test chambers of Vötsch Industrietechnik can be validated and are designed specifically to help you meet the requirements of the ICH Guideline Q1A.

Walk-in test chambers, stability tests, Votsch

The insulation elements of the walk-in test chambers for stability tests can be optimally adapted to an existing building structure since adherence to standard dimensions is not necessary. The standard height is 2700mm; other dimensions are possible. Chamber volumes from 10 up to 300m2 can be supplied by Vötsch Industrietechnik.

Standard scope of delivery

  • An excellent mechanical rigidity and optimum thermal insulation are ensured thanks to PU insulation chamber elements (CFC-free) with easy-to-clean, corrosion resis- tant double sided metal plate coating. Panels on the in- side and outside are painted RAL9010.
  • Insulated heavy duty floor construction covered with slip resistant, chequered plate stainless steel.
  • Lockable test chamber door with insulated observation window and emergency opening facility. The door frame heater prevents the forming of condensate during high humidity operation.
  • A pressure relief valve is fitted to the chamber wall.
  • Heating and cooling system consisting of ceiling evaporator with integrated electrical heater and air-cooled refrigeration unit.
  • Powerful axial fans ensure continuous intensive air circu- lation as well as uniform air distribution and temperature conditioning.
  • Climate conditioning system with energy saving ultra- sonic humidifier and separate dehumidifier.
  • Micro-processor controlled control system corresponding to GAMP-GUIDE and FDA 21 CFR Part 11 and EU GMP Annex 11, with maintenance-free electronic temperature/ humidity sensor.
  • Fully integrated user management in the control panel.
  • The switch cabinet incorporates the complete electrical section with fuses, protection-, switch-, control-, and regulation appliances. Wiring and electrics are strictly conform to safety regulations for electrical installation and materials acc. to the European Machinery Directive.
  • Safety temperature limiter for electrical heater and test
  • Specimen protection thermostat tmin / tmax and over humidity protection.
  • Multi language touch panel (German, English, French, Spanish, …).

Most important options

  • Software package SIMPATI Pharma for recording and processing of measurement values
  • Integrated Datalogger
  • Networking of several systems
  • Serial interface RS 232 C
  • Additional temperature and / or humidity sensor
  • Acoustic and optical warning signals
  • Refrigeration unit, water-cooled
  • Connection to customer provided chilled water circuit (e.g. +6°C)
  • Additional entry ports
  • Demineralisation unit with exchangeable cartridges for connection to local water supply
  • Constant temperature chamber (without controlled humidity)
  • Shelf systems
  • One-point calibration
  • Spatial calibration
  • Qualification documentation for equipment and SIMPATI software
  • Special voltages
  • Analog outputs
  • Maintenance contracts with definded response time
  • Further options available on request