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    Email: info@tritec-klima.de

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    Climatic Rooms for stability testing (acc. to ICH)

    Climatic rooms for stability tests play a central role in pharmaceutical research: the reproducibility of climatic conditions is crucial for the development and approval of new active ingredients and products. A stability test provides information on how the test unit behaves or changes under certain conditions and over a certain period of time. tritec® climatic rooms for stability tests are compliant according to the ICH guideline and are the ideal choice for your laboratory to reliably emulate climatic conditions for the tests of your pharmaceutical products. We only use the latest technologies for cooling, temperature and humidity control to guarantee the precision and performance of the climatic room while maintaining energy efficiency.

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    tritec®-Climatic Rooms – Equipment on customer’s request

    Stability tests have an important part in the development and approval of new drugs and pharmaceutical products. The target of stability testing is to find out how the products or substances will change under certain conditions during a particular time period

    tritec®-climate rooms the latest technology to simulate and maintain environmental parameters individually or linked precisely accurate. Microprocessor-controlled program, sequence, continuous or profile controller with integrated computer for time steps or cyclical operations, optionally change parameters Temp. / Humidity, day / night, light / dark phases and Others Circuits are possible. Records of all operations via recorder, controlled with different feed rates, but also on digital timer. Operation and life phases for documentation are unproblematically  Safety equipment such as high and low temperature, among other things, either visually and acoustically, even delayed acoustically, are standard.

    • Temperature range from -40°C up to 80°C (to –85°C partially)
    • Humidity range from 5% rel. hum. up to 95% rel. hum.

     

    Self-supporting wall, ceiling and floor elements
    In sandwich construction type, 60 to 150 mm thick thermal insulation made from polyurethane
    hard foam (closed cell) with a foam density of 40 kg/m³ and a thermal conductivity group 025 according to DIN 4108.

    Thermal bridge free cell elements, sturdy and measurement accurate. Element connection via slot/spring system with PE foam band sealing between the elements inside and corrosion protected eccentric clamping locks. Wall and ceiling elements inside and outside made from steel sheeting, galvanised, with antimicrobial SmartProtec coating, colour: white.

    Door width adjustable from 700 up to 1000 mm x 2000 mm, single leafed. (on request bigger sizes as a double-leafed door), Door hinge selectable DIN right or left, door in the wide side of the cell. Door opening to the outside, close fitting with magnetic sealing profile.

    Features according to customers request:

    • Capacity: 5 m3 to 100 m3, other sizes on request
    • Horizontal / vertical air convection provides excellent uniformity
    • electronic PID controller for temperature
    • Cable port of 30 mm to 200 mm diameter
    • On request: stainless steel housing
    • On request: CO2 electronic controller (1% up to 20%)
    • Wide range of accessories

    The large number of variations in features, size, current and future applications, use any existing energies should first be carefully clarified by technical discussions. This includes meaningful offers, working sketches (floor plan, front view, vertical section). Planning and decision-making tools, carefully thought, can save a lot of money.

     

    Your wishes are our mission!
    Please contact us.

     

    Have we piqued your interest? Please download our PDF-Formular below to get more details. Save and print the filled out formular and send it back to us! We will work it out immediately and get in contact to you!

    tritec® climatic rooms for stability tests comply with the ICH guideline

    Choose a climatic room from tritec® and receive a reliable product that can be freely adapted to your specifications and therefore optimally integrated into your laboratory. Our tritec® climatic rooms for stability tests comply with the ICH guideline and meet all requirements of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). You can rest assured that your durability tests will be performed under optimal conditions. Of course, both short-term and long-term tests can be carried out in the climatic rooms by tritec®. The climatic rooms can serve a temperature range from -40 to +80 degrees Celsius, sometimes even down to -85 degrees Celsius, and a humidity range from 5 to 95 percent relative humidity. Thus, the stability tests of your products can be reliably adapted to the prevailing climatic conditions of the consumer region.

    tritec® climatic rooms deliver reliable results

    The performance of stability tests in climatic rooms is subject to strict requirements formulated by organisations such as the ICH. At tritec® you receive products according to the ICH guideline, therefore, you can fully rely on their functionality. With our climatic rooms you reproduce ideal conditions under which you can test your samples.

    State-of-the-art technologies enable the authentic simulation of environmental parameters within the climatic rooms. Changing parameters is also possible: temperature and humidity, day and night cycles with light and dark phases can easily be programmed. The climatic rooms for stability tests are constructed in the tried and tested sandwich construction method and is insulated according to heat conduction group 025 according to DIN 4108. The wall and ceiling elements are self-supporting and made of sheet steel galvanized in the Sendzimir process with an additional antimicrobial coating. The recording of all operating procedures, safety devices with optical and acoustic alarm is standard.

    Are you interested? Please fill out our PDF form and send us your enquiry via email. tritec® realizes your individual and powerful laboratory inventory, on which you can rely at any time without restrictions.