Shortening of incubation times in Streptavidin plate production : implementation of one-piece flow production
Perälä, Aleksi (2024)
2024
All rights reserved. This publication is copyrighted. You may download, display and print it for Your own personal use. Commercial use is prohibited.
Julkaisun pysyvä osoite on
https://urn.fi/URN:NBN:fi:amk-2024102726865
https://urn.fi/URN:NBN:fi:amk-2024102726865
Tiivistelmä
Thesis explores the feasibility of shortening the incubation times used in Streptavidin (SA) plate manufacturing process. During the incubation process the Streptavidin protein is coated onto polystyrene surface of microwell plate cup using passive adsorption. Manufactured SA plates are used as base for analyte specific coating process of Point-of-Care (POC) immunoassay tests. Aim of this study is also to examine how SA plates would be produced with shortened incubation times and how it would affect to the production output.
Topic of the thesis is formed based on implementation of one-piece flow manufacturing strategy of POC tests. Implementation of one-piece flow strategy in the production of POC immunoassay tests requires shortening of the incubation times used in the SA plate manufacturing. Production of the POC immunoassay tests is complex process containing multiple process phases with long incubation times and storage steps which increases lead time of the manufacturing process.
Effects of shortened incubation times to SA plates performance and quality was evaluated with quality control tests. Process flow simulations were prepared to estimate how SA plates would be manufactured with shortened incubation times and how it would affect to the production output. The study includes both theoretical and technical aspects, including alternative incubation methods and quality control tests.
Results of study indicate that the incubation times used in SA plate manufacturing could be shortened with 81 – 59 % allowing to reduce lead time of SA plate manufacturing from 3 days to 1 day. The adsorption of Streptavidin to polystyrene surface could be improved by increasing the incubation temperature. Shortening the incubation times does not significantly impact the quality and performance of the SA coated plates. However, the reduction in incubation times is only beneficial for smaller batch sizes. For the smaller batch sizes the solution manufacturing processes of SA plate coating need to improved so that the shortening of incubation times would be profitable.
Topic of the thesis is formed based on implementation of one-piece flow manufacturing strategy of POC tests. Implementation of one-piece flow strategy in the production of POC immunoassay tests requires shortening of the incubation times used in the SA plate manufacturing. Production of the POC immunoassay tests is complex process containing multiple process phases with long incubation times and storage steps which increases lead time of the manufacturing process.
Effects of shortened incubation times to SA plates performance and quality was evaluated with quality control tests. Process flow simulations were prepared to estimate how SA plates would be manufactured with shortened incubation times and how it would affect to the production output. The study includes both theoretical and technical aspects, including alternative incubation methods and quality control tests.
Results of study indicate that the incubation times used in SA plate manufacturing could be shortened with 81 – 59 % allowing to reduce lead time of SA plate manufacturing from 3 days to 1 day. The adsorption of Streptavidin to polystyrene surface could be improved by increasing the incubation temperature. Shortening the incubation times does not significantly impact the quality and performance of the SA coated plates. However, the reduction in incubation times is only beneficial for smaller batch sizes. For the smaller batch sizes the solution manufacturing processes of SA plate coating need to improved so that the shortening of incubation times would be profitable.