Utilization of environmental monitoring information in pharmaceutical manufacturing

Abstract

In the manufacturing industry in general, digitization has been a big trend for some time now. However, manufacturing companies do not yet know how to utilize all the data they collect about production processes and thus gain additional value. The pharmaceutical industry is very different industry compared to other manufacturing industries and requires the manufacturer to closely monitor the processes to guarantee their reliability. Pharmaceutical manufacturers also have to follow exact requirements and laws, which are monitored by external parties. The purpose of this thesis was to focus on pharmaceutical manufacturing and environmental monitoring data that is collected from production processes. The company, for which this thesis was done, needed to find out how the monitoring data of their current environment is utilized and how it could be developed. The company was aware that they collect certain information in order to meet the requirements for pharmaceutical manufacturing, but there are still gaps in how they utilize this collected information. A lot of information in the pharmaceutical industry is collected only because of requirements, and companies do not always think about utilizing that information for other purposes. The answered research question of this thesis was “How environmental monitoring data can be utilized better in a pharmaceutical production environment?”. The research was conducted at one manufacturing site of a pharmaceutical company. The study was conducted as a semistructured interview study where the participants were personnel who are involved in monitoring the manufacturing environment at the site. The thesis also explores technical solutions for the utilization of environmental monitoring data, which were developed based on the interviews. Based on the interviews and the site's documents, it was possible to get an understanding of the current environmental monitoring programme and how the data collected from it is utilized. With the help of the key points that emerged from the interviews, it was possible to design technical solutions for better utilization of the environmental monitoring data in production. The results of the thesis are presented to the company and site, and the implementations of these technical solutions are not part of this thesis. The thesis brought up the current state of utilization of data in one area of the manufacturing industry, where there are still not many studies to compare with. Although this study only gave a small view of the utilization of data in the pharmaceutical industry, and especially of the utilization of environmental monitoring data. It is important to create the basis for possible new research in this area, where there is clearly a lot to be developed. The utilization of manufacturing industry data is to some extent comparable to pharmaceutical manufacturing, but due to its differences, it is important to remember the details that make it different. Because of the differences, this industry has different needs for the usage of data

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