SubscribeBINDER KBF climatic chamber with improved ICH light and new options: a complete high-performance solution for photo-stability tests.
Overall, the sun is a blessing for humanity; however, it can sometimes be very damaging to the shelf life of medications or pharmaceutical products. For this reason, the proof that the products will maintain their characteristics within the period of use must therefore, among other things, be provided through the photo-stability test with light. Here, the ICH guideline is binding since 1996. This is why BINDER made further optimizations to the KBF climatic chamber with ICH-conforming lighting.
BINDER climatic chamber KBF 720 With new ICH-conforming lighting
New: 2 spherical light sensors for reliable recording of the light values
Challenges for pharmaceutical companies
Since the fulfillment of this guideline must meanwhile be documented to the authorities mandatorily and without exception, pharmaceutical companies face great challenges in their test laboratories in this regard.
For the new photo-stability tests, samples must be exposed to a light amount of 1.2 million Lux* hours, as well as UV radiation of 200 Watt*hours /m² in climatic chambers with ICH lighting. But how can these light values be proven safely and objectively?
New options at BINDER for light tests
The fundamental prerequisite for reliable recording is the new option of light integration and display of the light values on the controller. This includes the automatic shutoff of the lamps (VIS and UV separately) when the freely selectable dosage values are reached.
Reliable recording of the light values is ensured by the two spherical light sensors which were developed for us and, due to their direction-independent characteristics, function more precisely than planar sensors.
Another important point for the testing authorities: BINDER chambers possess the APT-COM DataControlSystem software. Here, the light values can be saved and documented in a GLP/GMP-conforming form. In this manner, Binder offers the user comfortable options for documenting the test conditions in every phase.
BINDER does not simply sell the chamber, but a complete solution consisting of the chamber, software, documentation, calibration/validation, and service.
Valid for all international standards
All of this makes the KBF with ICH lighting a high-performance complete system solution for stability and photo-stability tests in accordance with all international standards and ICH guidelines, whether by Q1 A or Q1B, but naturally, also conforming to the requirements of the FDA or GLP/GMP.