The release of Annex 1 in 2022 marked a turning point, introducing stringent new requirements that challenge both end-users and service providers to rethink their approach. This regulatory update has brought cleanroom garments into sharper focus, raising questions about their development and the responsibilities of laundry services and operators in ensuring compliance with the revised guidelines.
The presentation examines the historical trajectory of cleanroom garment practices, shedding light on their intended function and the limited advancements made over the years. It also explores the implications of Annex 1, outlining how the updated requirements could shape the future of cleanroom operations. Central to this discussion is the practical question: can current practices and systems realistically meet these new expectations? Framed within the context of Quality Risk Management (QRM), the session provides a forward-looking perspective on how cleanroom garments can evolve to address both regulatory and operational challenges.
Matts Ramstorp…
…is a highly respected expert in cleanroom technology and biocontamination control, with a career spanning over four decades. Holding a master’s degree in chemical engineering and a PhD in Pure and Applied Biochemistry, he was appointed professor of cleanroom technology at Lund University, Sweden, in 2002. His influence extends internationally, having served as president of the International Confederation of Contamination Control Societies (ICCCS) from 1998 to 2000.
Since 1990, the Ramstorp family has operated three businesses dedicated to advancing knowledge and innovation in contamination control and cleanroom technology. Matts is widely recognized as an engaging lecturer, sharing his expertise with industrial professionals and academic institutions alike. Beyond teaching, he is a sought-after consultant, subject matter expert, and author of numerous scientific publications and textbooks, making significant contributions to the global cleanroom community.