Validation of buffer preparation and storage processes in lateral flow test manufacturing
Vähä, Kerttu (2026)
2026
Bioteknologian ja biolääketieteen tekniikan maisteriohjelma - Master's Programme in Biotechnology and Biomedical Engineering
Lääketieteen ja terveysteknologian tiedekunta - Faculty of Medicine and Health Technology
This publication is copyrighted. You may download, display and print it for Your own personal use. Commercial use is prohibited.
Hyväksymispäivämäärä
2026-01-21
Julkaisun pysyvä osoite on
https://urn.fi/URN:NBN:fi:tuni-202601201670
https://urn.fi/URN:NBN:fi:tuni-202601201670
Tiivistelmä
Lateral flow tests are rapid point of care diagnostic tools used for detecting different kinds of analytes. These fall under in vitro diagnostic devices and follow the regulation in vitro diagnostic regulation 2017/746. The basic working principle is that the sample is added to the sample pad where it flows through the test strip. As a next step, the sample reaches the membrane where the test result can be read. On the membrane, the antigens are immobilized on a nitrocellulose matrix. There the antibodies bind to antigens and remain at the site making a visually readable line to the test.
Buffer solutions play a crucial role in ensuring a working test. These are prepared as bulk and used in parts, which makes the manufacturing and storing processes significant parts of reliable test results. Furthermore, the validation of these processes is extremely important in ensuring reproducible tests and accordance with the regulations.
This Master of Science thesis is done in collaboration with Actim oy and focuses on validating the preparation and storing processes of three most used buffers in manufacturing at Actim.
The objective of this study is to validate the processes and find new minimum mixing times, maximum storage times and acceptance limits for these buffer solutions. Validation process includes the test plans, test batches, minimum mixing times and maximum storage times determination from manufacturing sized batches, validation plans, validation batches and validation reports. The research methods include sampling, pH, conductivity and absorbance measurements as well as statistical analysis.
In conclusion, the processes were validated, minimum mixing times updated to standard operating procedures, and maximum storage times proved suitable. In the future, the validation will be done for the other buffers used at Actim Joensuu site and continuous improvement will be conducted for all the buffer solutions’ processes.
Buffer solutions play a crucial role in ensuring a working test. These are prepared as bulk and used in parts, which makes the manufacturing and storing processes significant parts of reliable test results. Furthermore, the validation of these processes is extremely important in ensuring reproducible tests and accordance with the regulations.
This Master of Science thesis is done in collaboration with Actim oy and focuses on validating the preparation and storing processes of three most used buffers in manufacturing at Actim.
The objective of this study is to validate the processes and find new minimum mixing times, maximum storage times and acceptance limits for these buffer solutions. Validation process includes the test plans, test batches, minimum mixing times and maximum storage times determination from manufacturing sized batches, validation plans, validation batches and validation reports. The research methods include sampling, pH, conductivity and absorbance measurements as well as statistical analysis.
In conclusion, the processes were validated, minimum mixing times updated to standard operating procedures, and maximum storage times proved suitable. In the future, the validation will be done for the other buffers used at Actim Joensuu site and continuous improvement will be conducted for all the buffer solutions’ processes.