New generation of BINDER KBF climatic chambers for constant conditions exceeds ICH requirements
15 Oct 2008The difference between the new BINDER KBF climatic chambers for constant conditions and previous series is quite obvious even at first sight, since the double door has been replaced with a single door; the result is a smaller footprint with the same usable space, which gains valuable laboratory floorspace. What might not be as obvious at first are the technical developments in design, such as heavier insulation, a new pressurized steam humidification system, or the improved arrangement of heating, fan and refrigeration, as well as the improvements resulting from our new, fully automatic manufacturing processes. BINDER also offers patented light cartridges for the KBF ICH in accordance with the light testing requirements of the ICH guidelines, and new sensors for the KBF LQC for multidimensional measurement and documentation of light intensity, which will even “switch off the light” automatically once the test is completed. All of these design improvements and refinements are part of the reason why the new generation of KBF chambers exceeds all ICH requirements, makes work in the laboratory easier, and simplifies maintenance and servicing of chambers. New door system for greater homogeneity and easier handling
The new generation of KBF chambers benefits from advanced process technology. The inner chambers are bent fully automatically and welded at the same time in a single process step. This ensures high accuracy, process safety, and a consistently high standard of workmanship. Gaskets are provided on both the chamber housing and the outer door. The chamber also has a closing mechanism that pulls the door onto the housing and then presses it tightly against it. This provides a complete door seal, even if a user does not press hard against the door when closing it. The new KBF chambers also have a second, inner door, with separate gaskets and glass panels. This eliminates the cold thermal bridge that occurs with a single glass outer door, and which affects homogenous temperature and humidity distribution within the chamber interior. The large-surface glass door provides an optimal overview of the interior, making it possible to locate and access samples without the loss of temperature and humidity that can occur when the door is opened for a prolonged period.
Doors and door frames are equipped with separately controlled heaters. This prevents condensation on the inner and on the outer door. In this way, even highly critical parameters can be maintained without condensation. Keeping distances short provides optimal climatic conditions
Heating, fans and refrigeration, which in previous series were installed in the side of the units, were integrated into the back wall with the new models – a further optimization of the proven APT.Line. This frees up nearly the entire sidewalls for any customized access ports. Placing the heater element around the fans creates better spatial temperature and humidity distribution because of shorter air ducts, which results in a faster air exchange.
The newly developed humidification system injects pressurized steam through a valve into the interior, where the steam rapidly distributes homogenously and superfine throughout the entire chamber. Since the water is used only once, the system operates under sterile conditions. Another advantage is that the system will work independent of water quality, optionally with either distilled water or even tap water with a hardness of up to 8°dH. For water with higher hardness concentrations, BINDER offers the BINDER PURE AQUA SERVICE water purification system, which can be installed into the water feed line.
BINDER has equipped the new KBF with large-surface, split evaporators working in parallel, cooling the one section and dehumidifying the other. This not only achieves improved cooling efficiency, but also prevents ice formation, which could produce humidity variations within the interior. The new technology ensures homogenous operation, even in the lower temperature range up to 10°C.
The steam boiler and the refrigeration unit are modular, as are the electronics inserts, and are easily accessible within the designated equipment space. This ensures fast and cost-effective maintenance and servicing. Patented light cartridge for light tests according to ICH-Q1B and light measurement with the “golf ball”
New drugs are tested not only with respect to their stability under a wide variety of climatic conditions, but also in terms of photostability. In order to ensure comparable results from these tests, the light distribution must be uniform throughout the chamber interior. The high temperatures that result from external irradiation with so-called sun testers are a known problem. In BINDER KBF chambers, only the effects from light exposure are measured, and not any changes due to heat release by the light source. BINDER has developed special light cartridges with a combination of daylight and UV light for these tests. A reflecting grid in the bottom of the glass cartridge provides homogenous irradiation throughout the entire usable space The light cartridges ensure compliance with the frequency range required by ICH guidelines, without affecting the temperature in the interior. Handling is easy. The cartridges are inserted into the inside of the chamber in place of an insertion rack, and can be easily removed after the completion of tests.
BINDER developed its Light Quantum Control (LQC) package for measuring and documenting the effects of light exposure by means of sensors, which can be placed directly next to the samples on top of a small base, much like a golf ball onto a tee. These patented sensors capture the light not only above, as in conventional systems, but multidimensionally from the sides as well. An additional efficiency factor is that the sensors automatically switch off the light as soon as the required values are reached. Additional KBF versions and availability
The new KBF chambers are offered in the standard version for temperature and humidity tests specifically for the ICA Q1A guideline, or as KBF-ICH series with test parameters such as temperature, humidity and light for the ICH Q1B guideline, with additional light measurement and metering control. These chambers will be available in sizes of 240 L and 720 L interior volume, and the initial size of 240 L will be available as of Q4 this year.