On October 17, 2024, Nataša Štirn, M.Sc., QA Manager and Co-Owner at Klimer, Slovenia, participated in the prestigious International Symposium on Contamination Control (ISCC 2024) in Milan. Teaming up with Conor Murray from 3dimension and Klemen Škrlec from Novartis, she presented a pioneering case study focusing on aligning cleanroom compliance with the latest EMA and PIC/s Annex 1 regulations, while paving the way for the Life Sciences and Pharma industry toward carbon neutrality.
Their collaborative presentation highlighted a comprehensive approach to cleanroom contamination control, emphasizing the integration of Pharma 5.0 initiatives—including predictive quality and digital twins for real-time product release. The session underscored the importance of optimizing airflow patterns in cleanrooms to achieve both regulatory compliance and energy efficiency, thus enhancing product quality and patient safety.
The groundbreaking case study introduced at ISCC 2024 emphasized:
Application of ISO 14644-4:2022 for cleanroom design and ISO 14644-16:2019 for energy efficiency,
Achieving annual energy savings of €47,000 and reducing energy consumption by 376 MWh,
The role of Contamination Removal Efficiency (CRE) and Air Change Effectiveness (ACE) in improving cleanroom airflow and contamination control.
This presentation provided valuable insights for professionals dedicated to sustainable cleanroom design and comprehensive Contamination Control Strategies (CCS).
In addition to her presentation, Nataša represented the Slovenian Cleanroom Sociaty (SCS) at the ICCCS delegates' meeting, where SCS was officially welcomed as a member. As Vice President of SCS, Nataša introduced the association's goals and missions, emphasizing Slovenia's commitment to advancing cleanroom technologies and industry standards.
This dual involvement underscored Slovenia’s expanding influence in the global cleanroom community and highlighted SCS’s dedication to promoting excellence in contamination control and sustainable practices.
