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

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