tritec® Climatic Cabinets for stability tests ( acc. to ICH-guidelines)
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® Climatic Cabinets the ideal solution for stability testing of pharmaceutical products according to the ICH – Directive. Temperature range up to 70 °C and moistening and dehumidification to 96% rel. hum.
tritec®-Climatic cabinets for stability tests (acc. to ICH-guidance)
Capacity
- 400 Litres
- 600 Litres
- 1350 Litres
Air circulation
for rapid and uniform temperature and humidity control, reducing the gradients to a minimum.
Microprocessor-controlled temperature and humidity controller
- With digital LCD-display.
- Entry with membrane keypad, readable on LCD-display.
- Signalling in event of excess and falling of the set point acoustically.
Temperature ranges
- -2°C to 70°C / Temperature accuracy +/- 0,3°C
- 15°C to 60°C / Temperature accuracy +/- 2,0°C
- Other temperature ranges on request
Humidity ranges
- from 20% to 96% rel.hum. / humidity accuracy +/- 4 % r.F.
- from 40% to 90% rel.hum. / humidity accuracy +/- 5 % r.F.
- Humidity provided by means of very fine atomising using ultrasonic humidifier.
Water quality: For the humidity system distilled or deionised water has to be used. The cabinet can be connected to the own maintenance. Optional it is possible to use a water tank (10 litres) above or beside the cabinet. The water pressure should not exceed 1bar.
Solid door
- With right or left-hand hinge
- Partially with Inspection Window
- Optional with door lock
Additional accessories:
- Software
- Door lock incl. 2 keys
- Stainless steel shelves
- Illuminated shelf
- Printer (listing)
- Socket outlet (damp room) located in the cabinet interior
- -Wall opening with piping connections and screw cap
- Castors
- CO2 fumigation
Have we piqued your interest?
For more details please refer to the technical data sheets.
Please select your preferred model: (other sizes on request)
Climatic Cabinets for stability tests with reliable results
In order to determine the shelf life of medicinal products, climatic cabinets are used which ensure constant climatic conditions. Pharmaceuticals must comply with specifications defined from a microbiological, chemical and physical point of view over a certain period of time. For example, the active ingredient content must not fall below a predetermined guideline value (e.g. 90 percent) over the duration of a stability test. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, or ICH for short, provides precise guidelines on how such stability tests should be carried out.
New drugs are subjected to both long-term and short-term tests. The latter are so-called accelerated stability tests, which are usually used in addition. For a maximum of six months, the samples are stored in their final packaging at a temperature of 40 degrees Celsius and a relative humidity of 75 percent in a climatic cabinet. In order for a drug to be released, three batches in particular must be tested under long-term conditions. Such tests are carried out for a maximum of five years and the climatic conditions depend on the respective consumer region. These are either 25 degrees Celsius and 60 percent relative humidity or 30 degrees Celsius and 65 percent relative humidity.
tritec® climatic cabinets comply with the ICH guideline
Organizations such as ICH place high demands on the performance of stability tests. At tritec® you get high-quality climatic cabinets, which are perfectly adapted to the given guidelines. With our high-quality laboratory equipment you ensure reliable quality assurance. Our climatic cabinets simulate perfect conditions under which you can check that your samples fully meet the specified criteria.
We offer you climatic cabinets with volumes of 400, 600 and 1,350 litres. Depending on the size, these units have a temperature range between -2 and 70 or 15 and 60 degrees Celsius. Alternatively, we can manufacture a device with a temperature range of your choice. Thanks to modern technology, we achieve a particularly high temperature accuracy. Optionally we equip your climatic cabinet with an acoustic over-temperature alarm, so that you always keep an eye on the compliance with your target values.
To ensure ideal climatic conditions, our units can also be equipped with an ultrasonic humidifier, which ensures constant ultra-fine atomisation. Depending on the size of the climatic cabinet, this allows a humidity range of 15 to 90 or 30 to 96 percent.
Using intuitive operating elements with digital LCD display, you can set and program the temperature and humidity ranges exactly according to your specifications. With tritec® climatic cabinets you carry out short and long term tests which fully comply with the current requirements of the ICH guideline. Benefit from the precise results that our devices provide.
Your individual climatic cabinet with perfect configuration
At tritec® you get exactly the right climatic cabinet for your laboratory. We will be happy to adapt your desired device with further accessories, such as additional shelves, a water container for distilled water or a door lock. You can also freely select the door flap or have a viewing window integrated. Our experts are at your disposal for advice and show you the possibilities you have when configuring an ideal climatic cabinet for your laboratory.
In addition, the tritec® team is at your side for the maintenance and servicing of your equipment as well as GMP-compliant qualification and calibration. Our comprehensive services apply to both our own and third-party equipment.
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