Pharmaceutical manufacturing is a highly regulated industry governed by the strict requirements of GMP (Good Manufacturing Practice). These standards ensure that medicines are produced and controlled in accordance with established quality protocols.

“We are regularly audited by several authorities, including the Swedish Medical Products Agency. A fundamental requirement to pass these inspections is that our measurements are of high quality – that we have control over our instruments, possess the right expertise, and can trust the values we obtain,” says Stellan Carlsson, head of one of the calibration units at AstraZeneca in Södertälje.

Thousands of Calibrations Each Year

Every year, Stellan Carlsson and his team perform thousands of calibrations in areas such as temperature, humidity, conductivity, pressure, flow, electrical quantities, and mass.

“We calibrate virtually all types of measuring instruments used in our manufacturing processes. Our mission is to ensure that the measurement equipment functions correctly, detect any deviations, and manage them appropriately. Together with our colleagues, we carry out around 16,000 calibrations annually at our Södertälje facilities,” he says.

Calibration involves comparing a measuring instrument against a traceable reference – a standard with a known value. The purpose is to determine how much the instrument's reading deviates from the correct value.

“Reliable measurements are critical for controlling production and ensuring quality. If the measured values are inaccurate, the consequences can be significant – both in terms of quality and cost,” says Stellan Carlsson.

RISE Ensures Traceability

When calibrating a scale, for example, a reference weight with a known mass is used. But how can one ensure that the reference weight itself is accurate? The answer is traceability – and RISE.

“RISE has long ensured our traceability by calibrating the reference standards we use in our work,” says Stellan Carlsson.

Traceability means that a measurement result can be traced all the way back to the international definition of the unit, through an unbroken chain of calibrations with known measurement uncertainties.

AstraZeneca’s scales are calibrated using AstraZeneca’s own reference weights, which in turn are calibrated against RISE reference weights – forming a chain that ultimately links back to Sweden’s national kilogram at RISE.

“It is the traceability chain that ensures one kilogram is the same everywhere in the world. It’s a fundamental requirement for international trade, research, and industry. At RISE, we offer fully traceable calibrations across nearly all measurement quantities and at all levels – from accredited calibrations to highly specialized calibrations at our national metrology laboratories,” says Petra Lantz, Head of the Control and Calibration Unit at RISE.

Comprehensive Solutions and the Future of Metrology

RISE offers more than just calibration – it also provides advisory services, training, and metrology support, such as courses in measurement uncertainty and weighing technology. The goal is to give customers the right conditions for efficient and quality-assured production.

“With accurate measurement values, product quality, competitiveness, and profitability all improve. Incorrect measurements can lead to extensive rework, quality issues – and in the worst case, product recalls or loss of licenses,” says Petra Lantz.

Through the customer portal KWP Calibration, AstraZeneca has access to a digital instrument register with calibration status, history, and calibration certificates. When it's time for calibration, the service is easily booked online. RISE's transport service collects the reference equipment in Södertälje and delivers it to Borås for calibration.

“Then we get it back, calibrated and ready. It works very smoothly with extremely high delivery reliability. We also have a close dialogue with RISE and can resolve any issues quickly and efficiently,” says Stellan Carlsson.

Towards a More Data-Driven Future

The future of metrology is about more than calibrating at fixed intervals. The vision is for measuring instruments to be able to indicate themselves when calibration is needed, based on how their readings change over time.

“We collect large volumes of measurement data and are constantly working to use it in smarter ways – to analyze trends, make better decisions, and further develop not only our measurements but also our processes. I believe there is great potential for continued collaboration with RISE in this area,” says Stellan Carlsson.

Ludvika has over 120 years of experience in power transmission innovation. They are experts in the art of moving energy from the source to the point of use. Transformers weighing up to 500 tonnes and shunt reactors the size of truck cabins roll out of the Hitachi Energy factory. The production environment is high-tech - and the digitalisation journey continues.

"Discussions with RISE have opened our eyes to fibre optics as a technology for measuring critical parameters. Fibre optics can provide us with much more information than traditional sensors, and in real time. This is crucial for optimising our processes and taking the next step in digitalisation," says Christos Athanasopoulos, Principal Engineer at Hitachi Energy's Transit R&D department.

Francisco Penayo, R&D specialist at Hitachi Energy:

"To become more data-driven in manufacturing, you need this kind of data. We can't use AI or other machine learning tools without models, and the models are based on data from the manufacturing process."

Fibre optics paves the way for smarter manufacturing

In the manufacture of transformers and high-voltage components, the use of thermocouples for temperature measurement has long been the standard, but fibre optics offers more possibilities. The technology is based on passing light through thin glass fibres, allowing very accurate measurements even in hard-to-reach environments.

As fibre optic sensors are insensitive to electromagnetic radiation, they work well in high voltage applications. In addition to temperature, fibre optic sensors can also measure moisture and vibration. This gives Hitachi Energy a nuanced picture of what is happening in different parts of the production line.

"We use this information to improve our simulation models. This leads to better designs, better test results and ultimately more durable products. If things go well, there are plans to integrate fibre optics directly into our products, for example in transformers and bushings. In this way, we can not only optimise production, but also help our customers to optimise use and operation," says Francisco Penayo.

"RISE has deep knowledge"

Maximilian Patzauer is a researcher and project manager and part of the fibre optics team at RISE. He points out that fibre optic sensors have been around for a long time, but for high voltage products they are still relatively new. According to Patzauer, RISE's role in the collaboration has been very much to open doors and show what is possible - then it is up to Hitachi Energy to choose which solutions to go ahead with.

"Hitachi Energy is a world leader in its products and its manufacturing is very advanced, but with large and expensive processes comes the pressure to make sure nothing breaks. You don't want to put in sensors that could have a negative impact. The customer has to make sure that the digitalisation steps are big enough to make a difference, but at the same time proceed with caution," says Maximilian Patzauer.

Together with RISE, Hitachi Energy has conducted two feasibility studies in which the parties have tested fibre-optic sensors, for example for moisture measurement. Today, the company is working directly with RISE to develop the next generation of fibre optic measurement technology. The RISE team has carried out tests and measurements both on-site at Hitachi Energy in Ludvika and in its own laboratory. RISE has also delivered tailored lectures and workshops on fibre optics for Hitachi.

"RISE has in-depth academic knowledge, is focused on projects and is used to delivering. "We are in direct contact with the experts at RISE and have ongoing discussions. This makes the collaboration both faster and better," says Francisco Penayo of Hitachi Energy.

Fibre optics is an important key

Hitachi Energy in Sweden is currently experiencing strong growth with 7,000 employees, of which almost 5,000 are based in Ludvika. The goal is to have a total of 8,000 employees by 2030. To cope with this growth, we need not only more production capacity, but also more efficient and smarter manufacturing.

"We are investing billions in Ludvika over the coming years. If we are to achieve sustainable growth, we need to make better use of our resources, which means increasing the use of data. Fibre is an important key to this," says Francisco Penayo.