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The importance of software validation increases since the need for high usability and suitability of software applications grows. In order to reduce costs and manage risk factors, more and more recommendations and rules have been established. In the field of pharmacy the vendors of so-called chromatography data systems (CDSs) had to implement the guidelines of the Code of Federal Regulations Title 21 (CFR 21) during the last few years in order to fulfill the increasing requirements. The CFR 21 part 11 deals with electronic records and signatures. This part is binding for each company in the regulated environment that wishes to create, edit and sign electronic information instead of printing them on paper. Subsection CFR 21 part 11.10(h) explains how to perform an input check for manual user entries as well as for data that will be collected from an external device. In this article we present an approach performing the double entry method on data provided by the hardware instrument in order to investigate possible influences on the raw data by the handling CDS.
A software tool has been written which allows us to communicate with a high-performance liquid chromatography (HPLC) detector and acquire data from it. The communication is completely independent of a CDS which is started separately and connected to the same system. Using this configuration we made a parallel data acquisition of two instances at the same time possible. Two CDSs have been tested and for at least one of them it has been shown that a comparison of the acquired data can be done as with the double entry method for the data verification. For the second CDS we checked whether it would be applicable after a few modifications. The given approach could be either used for a live data verification of produced raw data or as a single test during a software operational qualification to verify the data acquisition functionality of the software.
A conductivity-based, batch-optimized system for analyzing the total of carbon parameter in water
(2023)
In cooperation with the company Purification Membranes Analytics GmbH (PMA), a prototype has been developed that analyzes the total organic carbon (TOC) content of water samples based on a complex conductivity measurement. In the process, a batchoptimized system was developed that delivers qualitative results even in highly polluted waters. This method requires small sample volumes and was assembled using an ultrapure water system, a sample mixing system, various electronic control units and a miniTOC system that uses a UV light source to decompose organic carbons and outputs differential values using two conductivity sensors. During the project, a fully automated prototype was developed and is ready for use. In the future, this method could support common methods and lead to more accurate statements on water quality in a cost-effective manner.
New technologies leading to better and more efficient light emitting diodes. The emitted radiation reaches higher energy levels and lower wavelengths especially in the UV-C spectrum. UV-C light has a cancer inducing effect on human cells. Therefore it is necessary to work in a safe way with those devices.
This work is focused on an open-source solution for rapid 3D printing of an safe UV-C radiation measuring device. Especially for research groups or universities which can not afford big safety labs.
After modeling and printing the prototype, a series of tests has shown the functionality of that UV-C Diode test system. By using black printing filaments and infill rates over 50 %, the transmission of light could be prevented and the system worked well.