Standards for sensors in sterile environments
The Engineering Network Ltd
Posted to News on 11th May 2026, 12:00

Standards for sensors in sterile environments

The new Annex 1 requirements make the careful selection and integration of sensor technology essential. Hygienic, flexibly mountable stainless-steel sensors from Leuze help you to comply with the requirements.

Standards for sensors in sterile environments

Previously, decontamination was considered sufficient for sensors and reflectors installed in a way that interrupted first air. Annex 1 "Manufacture of Sterile Medicinal Products Guideline" requires that these components also be treated with validated, penetrative sterilisation methods (e.g., autoclaving).

The image show an example of an Annex 1 compliant solution: Leuze ToF sensors mounted on the side or underneath the product reliably detect it without entering the first-air area, so the sensors do not need to be sterilised.

With over 60 years of experience, Leuze has become an expert in innovative and efficient sensor and safety solutions in automation technology. Today, around 1,300 Sensor People worldwide use curiosity, passion and determination to drive progress and change. Their motivation is the lasting success of their customers in a constantly changing industry.

Leuze offers its customers an individual competitive advantage through intuitive and reliable solutions for safe and non-safe position detection. For example, switching and measuring sensors, identification systems, solutions for data transmission and image processing.

As a family-owned company and safety expert, the company also focuses on components, services and solutions for occupational safety. Thanks to its broad and in-depth application expertise in the machine and system construction, Leuze is a competent and flexible partner for customers with a wide range of industrial requirements.

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Leuze electronic Ltd

1B Fenice Court
Phoenix Park
Eaton Socon
PE19 8EW
UNITED KINGDOM

+44 (0)1480 408500

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The Engineering Network Ltd