Automated disinfection systems in GMP environments
Evolving roles, practical realities and strategic integration
Reinigung & Desinfektion
Abstract
Automated disinfection systems, such as UV-C robots, aerosolized hydrogen peroxide units, and hybrid platforms, are increasingly being used in pharmaceutical cleanrooms to reduce operator-dependent variability and enhance contamination control. Yet automation does not replace manual cleaning or periodic sporicidal treatment, both required under Annex 1 of the EU GMP Guideline. This article examines the capabilities and practical limitations of current technologies, such as shadowing, line of sight constraints, and material compatibility, alongside regulatory expectations for validation under a risk-based contamination control strategy (CCS). It outlines a structured pathway from risk assessment and pilot study through to routine integration, and presents the sustainability case for automation, including reduced chemical and water consumption, lower consumable and personal protective equipment (PPE) waste, arguing that these benefits only materialize when automation is planned alongside existing manual programs and not simply added on top of them.
Correspondence:
Stefaan Vanhalle
Tunnelweg 20, 2845 Niel, Belgium
s.vanhalle@staxs.eu
 | Stefaan Vanhalle is an experienced professional with over 20 years of hands-on expertise in various biotechnology fields, primarily within cleanroom and GMP-regulated environments. Since 2013, he has been working at STAXS®, part of CWS cleanrooms, a leading supplier of contamination control solutions and cleanroom products. For the past 8 years, he has held the role of R&D Manager, where he leverages his extensive background to drive innovation and develop effective solutions tailored to the stringent demands of controlled environments. |
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