How well a containment system operates can be made transparent with measurable values. For this reason, we carried out a series of measurements together with the Infraserv GmbH & Co. Höchst KG, in order to determine the containment performance of our HETdynamic filter system with the WIP and Rabs features.
Background of the measurement
For a lot of manufacturing processes, it is necessary to protect both the employees and the product to the same extent. Especially in the pharmaceutical industry, where pulverized pharmaceutical substances are processed to pills, dusts are released in the process that - either partially or completely - consist so-called APIs (Active Pharmaceutical Ingredients). These APIs or HAPIs (High Active Pharmaceutical Ingredients) are intended to achieve the desired effect in the finished medication upon intake. When manufacturing, however, it is necessary to equally protect both the employee against these substances as well as the product against contamination.
Containment therefore is a major issue in any industry, where the handling of risky products inevitable.
Process and results
The measurements were carried out according to the new ISPE Guideline „Assessing the Particulate Containment Performance of Pharmaceutical Equipment“. Thus, the filter system was firstly measured in normal operating condition. Extraction of the surrogate (a test dust made of naproxen sodium) was simulated in the filter system. The lab analysis of the measuring system showed that the HET filter system does not release any particles into the surrounding environment under normal operating conditions.
In the second scenario, a filter change was simulated. The integrated WIP system (Wash-in-place) wetted the filter cell inside the filter system with water. Afterwards, the filter cell was removed applying the safe-change protection-bag replacement technology, followed by the installation of a new filter cell. The measuring system was positioned directly in front of the filter system at the height of the filters. Another measuring system was positioned close to the mouth of the person performing the filter change. This was to simulate the breathing-in of contaminated air. The results of the test delivered a measuring value of 0.49 µg/m³., which corresponds to a technical categorization class of OEB 5.
Afterwards, two further tests were carried out. The measurement of a filter change with safe-change technology, yet without WIP feature resulted in a value of 1.95 µg/m³. For a filter change without protection bag, the measured result was 105 µg/m³.
Our conclusion: Confidence is good, but measurements are better…
…as we now can say with certainty, that very good workplace limit-values are achieved with our filter systems.
As a highly-specialized manufacturer of filter systems, we are also a competent partner when it comes to containment. With our products, we provide market solutions that are suitable for all containment requirements. Thanks to our filter systems, excellent workplace limit values are achieved, up to the OEB 5 range. A containment chain that is sustained from one production machine to the next, remains in effect with our filter systems.