Enhancing Operator Comfort and Contamination Control
Evaluation of an Integrated Airflow Garment System in compliance with EU GMP Annex 1
Ausstattung
Abstract
This study investigates an integrated airflow garment system developed for sterile cleanroom environments, with a focus on improved contamination control in alignment with EU GMP Annex 1 (2022) and comfort for the operators. The system incorporates adaptive top to bottom driven airflow, full facial coverage, and ergonomic design to mitigate CO₂ buildup, visor fogging, and user fatigue. Comparative testing, including particle emission (body box), CO₂ analysis, and reusability assessments demonstrated substantial improvements in operator comfort and environmental cleanroom compliance. While particle counts were marginally higher than a traditional garment system, all values remained within the maximum allowable particles of 0,5 μm per m3 as defined in the ISO 14644-1 for an ISO 5/GMP class A environment, supporting the suitability for higher grade pharmaceutical and biotechnological applications.
Correspondence:
Arthur Lettinga
Elis Cleanroom, Koopman Heeresweg 10, 8701 PR Bolsward,
Niederlande
arthur.lettinga@elis.com
 | Arthur Lettinga has been part of the Elis Cleanroom group for over 10 years. As Product Manager, he is responsible for driving innovation in process and product development, ensuring that cleanroom textiles meet the evolving demands of customers. A key aspect of his role involves providing regular training and education, not only on products but also on general cleanroom knowledge. |
Abstract
This study investigates an integrated airflow garment system developed for sterile cleanroom environments, with a focus on improved
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