Events


Oct
27
12:00 PM12:00

Successful Case Study on Energy Efficiency in Cleanroom Environments Presented by Nataša Štirn at ASHRAE CEIC 2024

Nataša Štirn, M.Sc., QA Manager and Co-Owner at Klimer, Slovenia, recently presented an innovative case study at the ASHRAE CEIC 2024 conference in Athens. Her presentation showcased the implementation of a Contamination Control Strategy (CCS) in alignment with Annex 1 requirements, which not only optimized energy consumption by reducing air volume flow rates but also emphasized the critical role of local airflow patterns around processes and workflows.

A key finding of the project was that Air Change Rates (ACR) alone do not guarantee effective cleanroom flushing quality. Instead, achieving proper mixing of “first air” with existing air at critical points within the cleanroom is essential. This approach led to significant reductions in both air volume flow rates and energy costs, without any compromise to product quality metrics. Additionally, microbiological control results showed marked improvement after implementing these changes.

A critical component of the success was the investigation and assessment of existing airflow patterns around processes and workflows. Smoke studies, conducted with MicroRite’s advanced equipment, played a pivotal role in identifying and analyzing these critical locations. MicroRite’s technology, which ensures neutral buoyancy, allowed for precise detection of areas needing improvement in airflow, supporting a more robust control strategy.

This case study highlights the potential for substantial energy savings in cleanroom environments while enhancing contamination control—a promising development for industries where energy efficiency and product quality are paramount.

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Oct
15
to Oct 18

Nataša Štirn at ISCC 2024: A Presentation on Cleanroom Compliance and Energy Efficiency

  • Google Calendar ICS

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.

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Founding Assembly of the Slovenian Cleanroom Society
Mar
22
11:00 AM11:00

Founding Assembly of the Slovenian Cleanroom Society

  • GZS Poslovna oaza (7. nadstropje) (map)
  • Google Calendar ICS

Recognizing the growing demand for expertise in cleanroom technology and contamination control, we are embarking on the establishment of an association dedicated to this vital field. Supported by the International Confederation of Contamination Control Societies (ICCCS), our initiative aims to foster professional development in cleanroom technology within Slovenia's thriving pharmaceutical industry and beyond. Joining forces with global counterparts, we are poised to implement international certification programs, ensuring optimal conditions for sensitive processes across various industries.

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Implementation of EU GMP Annex 1 in Practice
Mar
18
to Mar 21

Implementation of EU GMP Annex 1 in Practice

We are delighted to announce the successful preparation of a comprehensive week-long program focusing on cleanroom technology. It is with great pleasure that we extend our warm invitation to you to join us for these highly engaging events. Event Details: Dates: March 18th - March 22nd, 2024, Location: Various venues in Slovenia, Organizer: Klimer Stirn & Co d.n.o.

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Smoke Test Training
Jul
27
9:00 AM09:00

Smoke Test Training

Klimer ‘s first training for his employees and his business clients (Lek and Novartis) was a transformative experience, equipping participants with practical knowledge in smoke testing for the cleanroom industry. Through hands-on training with advanced equipment and expert guidance, attendees gained invaluable insights. This event exemplified Klimer's commitment to advancing industry expertise, leaving participants with enhanced skills, renewed confidence, and the ability to tackle real-world challenges effectively.

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Implementation of Annex 1 and New Partnership
Jul
26
2:00 PM14:00

Implementation of Annex 1 and New Partnership

In collaboration with our colleagues from Lek and in the esteemed presence of Mr. Conor Murray, the President of the Irish Cleanroom Society, we meticulously devised a hands-on implementation plan for the new Annex 1 regulations tailored specifically for Sandoz Pharmaceuticals d.d. As a testament to our enduring partnership and successful collaboration, Mr. Conor Murray graciously presented us with a symbolic gift, the Celtic Cross of Journeys and Meetings, signifying the strength of our alliance.

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Opening of Klimer’s New Offices and Calibration Lab  (20th July 2023)
Jul
20
10:30 PM22:30

Opening of Klimer’s New Offices and Calibration Lab (20th July 2023)

Speech at Opening of Klimer’s New Offices and Calibration Lab (20th July 2023) by Conor Murray - Chair International Confederation of Contamination Control Societies (ICCCS) 2022-2024, Convener ISO/TC09 WG2, Microbiological Contamination Control in Cleanrooms, Head of Delegation for Ireland at ISO/TC 209, Irish Subject Matter Expert ISO/TC 209.

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Opening of Klimer’s Education Center with Calibration Laboratory
Jul
20
3:00 PM15:00

Opening of Klimer’s Education Center with Calibration Laboratory

We are delighted to share an exceptionally joyful announcement with you! With great pride and enthusiasm, we invite you to the official opening of our new business premises. On this special occasion, we will formally present our new vision and business plans, while commemorating a significant milestone in our company.

Our spaces have been designed with our customers and colleagues in mind, and we are confident that you will be impressed by the modern facilities, comfortable areas, and innovative solutions we will offer.

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EU GMP ANNEX1 (Workshop 3)
Jan
24
9:00 AM09:00

EU GMP ANNEX1 (Workshop 3)

The workshop was the continuation of the EU GMP ANNEX1 (Workshop 2) event. Speaker Conor Murray, the Chair of Irish Cleanroom Society, highlighted specific critical changes in Annex1 and lead interactive sessions providing attendees with the understanding and means to implement the requirements of the new Annex 1.

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EU GMP ANNEX1 (Workshop 2)
Jan
23
9:00 AM09:00

EU GMP ANNEX1 (Workshop 2)

  • Radisson Blu Plaza Hotel Ljubljana (map)
  • Google Calendar ICS

The workshop was the continuation of the EU GMP ANNEX1 (Workshop 1) event. Speakers ICS chair Conor Murray and a representative from Rigel Life Science, Diego Bompadre highlighted specific sections with critical changes and lead interactive sessions providing attendees understanding and means to implement the requirements of the new Annex 1.

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EU GMP ANNEX1  (Workshop 1)
Nov
14
9:00 AM09:00

EU GMP ANNEX1 (Workshop 1)

  • Radisson Blu Plaza Hotel Ljubljana (map)
  • Google Calendar ICS

At the end of August 2022, the long-awaited updates to EU GMP Annex 1 were published. In the field of sterile medicine production, the document brings new standards that will mean changes for manufacturers. Two professional events were organized where we talked about how this will affect the industry and how manufacturers can prepare for the changes.

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