Fermion’s plant in Oulu manufactures methotrexate, among other products. Methotrexate is an active ingredient of cancer and rheumatoid arthritis drugs. The equipment is washed after the production process. Samples are taken from the washing solution and the equipment to be analysed for any pharmaceutical residues. The raw materials delivered to the plant, as well as the intermediate products and pharmaceutical ingredients produced at the plant, are analysed for any impurities.
Tomi Svahn joined Fermion a little more than two years ago to work as a quality control chemist. One of his duties is to validate and verify analysis methods – which is professional speak for ensuring that the methods used in analyses are reliable and repeatable.
“I was hired to work on a project to renew the wash analysis methods at Fermion’s plants in Oulu and Hanko. We have now updated some 140 methods.”
Svahn also participates in developing and validating analysis methods for new pharmaceutical ingredients. When a new compound arrives at the plant in Oulu, Svahn and other professionals organise the validation of the methods and review the results of the analyses.
Everything begins with cleanliness
Quality control is an essential part of pharmaceutical production. The pharmaceutical ingredients to be produced and the production equipment must be clean to prevent residues of other pharmaceutical ingredients from ending up in the batch of products.
According to Quality Control Chemist Tomi Svahn, Fermion’s quality control laboratory in Oulu conducts more than 10,000 analyses each year. Around ten per cent of these are wash analyses.
The solution that was used to wash the equipment – often a mixture of water and ethanol – is analysed, primarily by means of the HPLC method, or high-performance liquid chromatography. In addition, a wipe sample taken from the equipment is analysed.
“There are different limits for residues of different compounds in the washing solution and the equipment. For example, a methotrexate concentration of no more than one-millionth is permitted in the washing solution.”
A quality control chemist spends only a small portion of their working time in a laboratory, the domain of lab assistants. Tomi Svahn spends much more time in meetings, as well as writing validation reports and reviewing analyses, among other things, at the computer.
“However, I frequently work with laboratory assistants, supervising their work and ensuring that analyses are conducted correctly. Through Skype, I also cooperate with Orion’s experts in more faraway locations.”
Svahn says that variety and challenges make a quality control chemist’s work interesting. For example, if an analysis method does not perform as expected during validation, it needs to be further developed to ensure reliable and repeatable results.
The pull of the pharmaceutical industry
Svahn graduated from the University of Jyväskylä in 2015, having studied Applied Chemistry. An interesting job and career opportunities attracted him to Fermion. He became interested in the pharmaceutical industry during his studies. In addition to Applied Chemistry, he studied Organic Chemistry, and expertise in both of these fields is beneficial in the industry.
Best thing about Orion: “Collaboration and the opportunity to work with top professionals.”
“As a student, I was initially interested in organic synthesis – that is, the production of new chemical compounds. Then I found myself becoming interested in analytical chemistry: determining the composition of substances.”
Text: Pirkko Koivu