White Paper: Human Contamination and Controlled Access in Clean Room Environments – Compliance with Annex 1, Paragraph 7.2

Jason Carter, Nav-Team, Inc. Abstract

The critical issue of human contamination in clean room environments, with a focus on compliance with Annex 1, Paragraph 7.2, of the European Union Guidelines to Good Manufacturing Practice (GMP). Personnel represent a significant contamination risk in sterile manufacturing, introducing both viable and non-viable particles into controlled environments. Annex 1 mandates stringent access control to mitigate these risks, including minimizing personnel in clean rooms and tracking entry and exit points.

NAV Team’s advanced people counting and access control solutions help manufacturers comply with these regulations. The system offers real-time monitoring, precise bi-directional people counting with 99.8% accuracy, and seamless integration with existing systems through a simple API (Application Programming Interface). Additionally, prioritizes user privacy by using time-of-flight (TOF) technology, which avoids capturing images and ensures anonymous detection.