The symposium brought together experts from pharmaceutical manufacturing, microbiology, contamination control, validation, quality assurance and cleanroom technology, providing valuable insights into current Good Manufacturing Practice (GMP) requirements and practical industry experience.

Klimer d.n.o. actively participated in the event through a professional presentation delivered by the company’s Managing Director and President of the Slovenian Cleanroom Society (SCS), Nataša Štirn.

The presentation entitled:

“Recovery Time (ISO 14644-3) vs. Clean-up Time (EU GMP Annex 1)”

addressed one of the frequently discussed topics in cleanroom qualification and GMP compliance. The presentation focused on the key differences between the requirements of ISO 14644-3 and the expectations of EU GMP Annex 1 regarding the assessment of air cleanliness recovery following particle generation, as well as practical approaches to planning and executing qualification tests in cleanroom environments.

The symposium programme also covered a number of other highly relevant topics, including:

• Microbiological monitoring
• GMP facility design for ATMP manufacturing
• Aseptic processing support areas
• Validated cleaning and disinfection systems
• Material transfer strategies
• Regulatory updates and current GMP requirements

Participation in professional events of this kind is an important part of Klimer’s mission, enabling the exchange of expertise, continuous monitoring of evolving regulatory expectations, and active contribution to professional discussions in the fields of contamination control and cleanroom technology.

Klimer would like to thank the organizers for the invitation and the excellent organization of the event and looks forward to future opportunities for professional cooperation and knowledge sharing.

Expertise, Experience and Collaboration for Safer and More Efficient Controlled Environments.