Eltronic specializes in compliance and automation solutions for the Life Science industry. In particular, Eltronic’s strong automation and compliance competencies, as well as knowledge within industry standards (e.g., GAMP5, S88), were crucial for the client in the process of developing a plant in their cannabis production.
In the extensive project, all of Eltronic’s diverse competencies have come into play. The mechanical design of the plant was in place before Eltronic joined the project, hence the task was to deliver the actual contents of the plant.
Eltronic has been responsible for the development of automation design, PLC programming, and hardware design for automation management. In addition, Eltronic has produced electrical panels for the solution and ensured safe on-site assembly in a so-called ATEX zone, where special precautions must be taken. Earlier in the project, Eltronic’s Compliance department was also involved in establishing a Quality Management System (QMS).
Finally, Eltronic has secured documentation from start to finish in connection to the implementation of the process- and CIP plants in accordance with GAMP 5 (e.g., Risk Assessment, URS, FAT/SAT, FS/HS/SS, and IQ/QQ).
In 2018, a four-year trial scheme with medical cannabis came into force in Denmark. The purpose of the scheme was to give patients a legal opportunity to test treatment with medical cannabis, given that they had not benefitted from conventional medicine approved for use in Denmark. The trial scheme has now been extended for another four years.
The Danish authorities have high demands, and GMP is fundamental when it comes to the production of medical cannabis.
The quality must always be consistent and reliable – and there is no debating on this matter as it concerns legislation, rules, and guidelines. Therefore, it has been particularly important for the client to choose a supplier with extensive experience within the area of GMP.
Eltronic A/S competencies
Eltronic was able to deliver the project – from design to qualification/validation of the system – within six months. This also includes the delivery of components and the actual installation of the complete plant at the client’s production facility in Denmark.
Eltronic A/S’ competencies in the project: