Sterilisation

Providing calibration for an essential service

During the COVID-19 crisis there was increased demand for a continuous supply of sterilised medical devices. Around 50% of single use sterile medical devices are sterilised using ionising radiation, either gamma rays from radioisotopes or high energy electrons and x-rays from machine sources. The industry is highly regulated, and companies must meet specific requirements on the measurement of radiation dose. Products range from high volume devices, such as needles, wound dressings and blood collection tubes, up to more sophisticated products, such as cardiac stents and equipment to maintain blood oxygen levels.

NPL does not carry out the actual sterilisation, it provides the essential calibration to the international radiation sterilisation industry. Our industrial sterilisation dosimetry service is based on standard radiation fields and alanine dosimeters and we are one of the few laboratories in the world providing support and traceability. Usually the calibration is realised on a yearly basis or on-demand if any change is made to the sterilisation process, but there was increased demand during the COVID-19 pandemic.

Calibration of dosimeters is an essential step in the quality assurance process of gamma ray and electron sterilisation. NPL is a ‘critical supplier’ to many radiation sterilisation companies and we received requests from around the world to ensure that our calibration services remain available as industry strived to meet the challenges of maintaining medical device and PPE supply chains, as well as developing new diagnostic tests and treatments.