Metrology for Billions of Life-Saving Tablets

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.