The Danish allergy company ALK produces, among other things, allergy vaccines, and during thorough quality control, vaccines are sorted out if, for example, particles are detected in them.
Unwanted particles examined under microscopes
'All manufactured allergy vaccines undergo a 100% visual inspection, where every vial is screened for defects and deficiencies that may occur during production. During this quality control, it sometimes happens that particles are observed, and we use FORCE Technology to analyse these particles as part of our root cause analysis and deviation handling. It makes a huge difference for us, as we do not have the capability to examine the particles in the same way in-house. The particles are very small, for example 100 µm, and we would never have determined the material composition of the particle ourselves. It’s not something you can see with the naked eye', says Sophie Chakroun Jacobsen, Chemist – Visual Inspection & TBQ at ALK.
FORCE Technology has a large range of microscopes, which can analyse and detect, for example, particles and other contamination in products and production equipment. Additionally, they can characterise, for example, surface structure, roughness, and elemental composition.
The reference library is invaluable for root cause analyses
Over a longer period, ALK has been sending material present during production to FORCE Technology. Everything has been analysed and is now included in a reference library, which forms the basis for analysing ongoing cases:
'If the analysis shows that the found particle matches a bag we use in production, we immediately start investigating how it could have ended up in the finished product', continues Sophie.
She adds: 'The analyses then become part of our overall root cause analysis, ensuring that we find the right explanation and helping us to implement appropriate corrective actions so that we can prevent it from happening again. For example, if we get new hairnets, we immediately send them for analysis so they can also be added to the list'.
The reference library is invaluable to us and allows us to identify the cause much more quickly, which otherwise could have taken a significantly longer time.”
Continuous alignment of expectations
'We hold regular meetings with FORCE Technology, where we align expectations, and it really makes the whole process easier as we have gotten to know each other well over time', concludes Sophie Chakroun Jacobsen.
