Medical Device Design
Heilala, Janne (2019)
2019
Konetekniikan DI-tutkinto-ohjelma
Tekniikan ja luonnontieteiden tiedekunta - Faculty of Engineering and Natural Sciences
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Hyväksymispäivämäärä
2019-11-06
Julkaisun pysyvä osoite on
https://urn.fi/URN:NBN:fi:tuni-201910264107
https://urn.fi/URN:NBN:fi:tuni-201910264107
Tiivistelmä
The function of this thesis was to design a preliminary medical device and examine its lifecycle validation process in reference of the target organization policies. The produced documentation operates as a reference frame for constructing hardware and software requirements and validation support. The methodology of this work is based on the apparatus specific lifecycle design process and its results, literature research, implicitly presented theme interviews, and extract from quantitative and qualitative analysis. Guidelines and the validation process theories and practices are combined from company policies and represented in generalized form and cited for publicly available information.
A valid computerized medical production equipment design is heavily regulated and concerns the whole pharmaceutical industry. This Master's thesis presents a preliminary way to engineer a device from theory to practice. The purpose of the device was to run medicinal production automatically while imaging operator controls it behind a simulated touch screen panel. The sweep has special requirements as it is first in the world to be implemented automatically in sequence within a certain time domain. Therefore, requirements for the User Interface (UI) implementation was stated to be as minimal, reliable and as fast as possible. The radiolabeled medical gas is intended to be delivered to the patient during positron emission tomography (PET) imaging process.
The background of the PET imaging, the basics of medical radionuclide labeling and knowledge-based approach for the synthesis process principles are associated with requirements for the design of the UI and PLC for the production equipment. Additionally, the Good Automation Manufacturing Practice 5 (GAMP 5) enables a foundation for life cycle design (LCD) process of a computerized system. GAMP includes compliant Good Practice (GxP) and Good Manufacturing Practice (GMP) principles among many standards which are derived with latest complementary standardization norms.
In which ways global compliant cutting-edge medical technology equipment and software is planned, designed and constructed when GAMP 5 is set as a reference frame, and what does an asset validation documentation require and include to be sufficient or beyond GAMP? Previous question was stated as the main research question. Briefly as one of the main results, in response to the research questions, a new preliminary automatic UI was designed. It was constructed in Visual Basic environment with versatile C/C++ node.js modules, that were itemized and compiled into Hypertext Markup Language (HTML). Touch enabled Human-Machine Interface (HMI) framework enables operator to control process directly from multiple locations via input touch panel whenever there is an internet connection. Framework is supported by JavaScript nodes and real-time-relevant programmable controller logics (PLCs) made by Beckhoff. Other results of the work included raising awareness of the devices used in process industry. Additionally, the qualification parts of the validation process that relate to validating the device legally is found.
A valid computerized medical production equipment design is heavily regulated and concerns the whole pharmaceutical industry. This Master's thesis presents a preliminary way to engineer a device from theory to practice. The purpose of the device was to run medicinal production automatically while imaging operator controls it behind a simulated touch screen panel. The sweep has special requirements as it is first in the world to be implemented automatically in sequence within a certain time domain. Therefore, requirements for the User Interface (UI) implementation was stated to be as minimal, reliable and as fast as possible. The radiolabeled medical gas is intended to be delivered to the patient during positron emission tomography (PET) imaging process.
The background of the PET imaging, the basics of medical radionuclide labeling and knowledge-based approach for the synthesis process principles are associated with requirements for the design of the UI and PLC for the production equipment. Additionally, the Good Automation Manufacturing Practice 5 (GAMP 5) enables a foundation for life cycle design (LCD) process of a computerized system. GAMP includes compliant Good Practice (GxP) and Good Manufacturing Practice (GMP) principles among many standards which are derived with latest complementary standardization norms.
In which ways global compliant cutting-edge medical technology equipment and software is planned, designed and constructed when GAMP 5 is set as a reference frame, and what does an asset validation documentation require and include to be sufficient or beyond GAMP? Previous question was stated as the main research question. Briefly as one of the main results, in response to the research questions, a new preliminary automatic UI was designed. It was constructed in Visual Basic environment with versatile C/C++ node.js modules, that were itemized and compiled into Hypertext Markup Language (HTML). Touch enabled Human-Machine Interface (HMI) framework enables operator to control process directly from multiple locations via input touch panel whenever there is an internet connection. Framework is supported by JavaScript nodes and real-time-relevant programmable controller logics (PLCs) made by Beckhoff. Other results of the work included raising awareness of the devices used in process industry. Additionally, the qualification parts of the validation process that relate to validating the device legally is found.