A UK cleanroom conference addressing key drivers in the cleanroom industry
Wednesday 21 May 2025
Agenda subject to change. More speakers will be announced in the coming weeks.
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Steve Ward, Compliance Specialist at T-squared
Nigel Lenegan, Executive Director at Energy and Carbon and Tom Stanway, ex-AstraZeneca
Abstract
The pharmaceutical industry has long sought to balance regulatory compliance, operational efficiency, and sustainability in cleanroom environments. Over a decade ago, major pharma companies conducted groundbreaking studies on cleanroom optimisation, in which Nigel was directly involved. This presentation revisits those findings, examining their long-term impact and assessing how the industry has evolved using these insights.
Drawing on his 30+ years of expertise in GMP HVAC, cleanroom design, and ISO cleanroom standards, he will explore key lessons learned, technological advancements, and best practices that have emerged since.
This session will provide practical takeaways for cleanroom professionals, covering sustainable facility design, energy efficiency in controlled environments, and regulatory considerations. Attendees will gain a deeper understanding of how past research continues to shape the future of pharma cleanrooms, aligning with modern GMP expectations and industry sustainability goals.
Arthur Lettinga, Product Manager at Elis Cleanroom
Abstract
Working in a higher class cleanroom might require sterilization of cleanroom apparel. Apart from the fact that humans are the biggest critical contamination factor, in those high class cleanroom environments, minimizing – ideally eliminating –, contamination risk is key from your production processes. In order to do so, sterilisation of apparel would be one of the parts of the chain.
This presentation explores and compares the various sterilisation techniques used for cleanroom garments, including gamma irradiation, ethylene oxide (EtO) sterilisation and autoclaving. Moreover, it also highlights briefly the other parts of the chain, as this is as much as important as the sterilisation method itself.
Cecilia Pierobon, Technical Service Manager at STERIS
Abstract
The transfer of equipment and materials into and out of the cleanrooms and critical zones is one of the greatest potential sources of contamination.” (EU Annex 1, 2022). There are many different ways of transferring equipment and materials into the cleanroom and this will depend in your facility design and availability. This presentation talks about what are the important points to consider when designing a material transfer, what is the opinion on Annex 1 on this topic and shares a case study of how a complex case of material transfer was solved
Jamie Kelly, Research and Development Project Leader & Marta Underwood, Cleanroom Textiles Group Product Manager at Micronclean
Abstract
Annex 1, implemented in August 2023, mandates that all cleanroom garment systems must meet strict quality standards and undergo qualification
studies to determine their lifespan. This paper examines key compliance factors, including testing methodologies to ensure that reusable garment
systems optimise performance whilst ensuring garment longevity.
Nataša Štirn, Managing Director at Klimer Štirn & Co. d.n.o. and Conor Murray, Principal Consultant & Contamination Control Expert at 3dimension
Abstract
The presentation will delve into how the Pharma 5.0 roadmap integrates predictive quality and digital twins for real-time release, highlighting the importance of optimising airflow patterns in cleanrooms to balance energy efficiency and regulatory compliance.
The case study will explore our client’s request to reduce air volume flow rates (air exchange rates) without compromising product quality metrics. It’s the first-of-its-kind study, and we’ll emphasise:
Applying ISO 14644-4:2022 (design) and ISO 14644-16:2019 (energy efficiency)
Achieving significant reductions in air volume flow rates and energy costs without compromising product quality
The role of Contamination Removal Efficiency (CRE) and Air Change Effectiveness (ACE) in ensuring efficient airflow and contamination control
Kirsten Heukelbach, Head of Farmacy, Hammersmith Medicines Research Ltd (HMR) and Matt Stubbs, UK & Europe Sales Manager at ENVAIR Technology
Abstract
The integration of an Environmental Monitoring System (EMS) into an isolator is pivotal in ensuring the safety and quality of pharmaceutical and biotechnological products. The EMS plays a critical role in monitoring key environmental parameters, such as temperature, humidity, particle count, microbial contamination, and pressure, ensuring they remain within predefined limits essential for maintaining sterility and product integrity.
This presentation traces the journey of incorporating EMS into isolators, starting from the initial request by the client to the final system installation. It will focus on the critical parameters that must be controlled to safeguard the quality of the final product, aligning with the stringent requirements outlined in Annex 1 of the EU GMP (Good Manufacturing Practice) guidelines, which govern the production of sterile medicinal products.
Key aspects of the presentation include:
- EMS Design Considerations for Compliance: An in-depth look at how the EMS is designed to comply with Annex 1 guidelines, including continuous monitoring, real-time data collection, alarm systems, data logging, and trend analysis. Integration with isolator management system (IMS) will be discussed.
- System Design and Functionality: A detailed overview of the EMS components—sensors, control units, and software—and their respective roles in ensuring regulatory compliance and operational efficiency.
- Ensuring Compliance with Regulatory Standards: Exploration of how the EMS helps maintain compliance with international guidelines for sterile product manufacturing by monitoring, logging, and analysing environmental data to ensure compliance with required environmental conditions.
Matts Ramstorp, Founder, Owner, CFO, BioTekPro AB
Abstract
This presentation discusses the importance of cleanroom garments, particularly in Grade B aseptic cleanrooms. It highlights the historical development of cleanrooms and the role of cleanroom garments in controlling contamination and ensuring patient safety by emphasising the need for cleanroom garments to act as barriers to prevent the dispersion of particles and microorganisms from operators into the cleanroom environment.
Furthermore, the presentation delves into the evolution of cleanroom technology and the demands outlined in Annex 1 from 2022, emphasising the importance of quality risk management and adherence to stringent cleanliness standards. It discusses the use of barrier technology, such as isolators and RABS systems, to separate operators from the products being handled.
The presentation also touches upon the evolution of cleanroom garment fabrics, from plain weaves to twill weaves, and the implications of fabric structure on comfort and filtration effectiveness. It addresses the challenges of washing and sterilisation cycles on the integrity of cleanroom garments and the lack of standardised tests for evaluating garment integrity.
The increasing recognition of the importance of cleanroom garments in recent revisions of Annex 1 guidelines and the shift of responsibility for garment integrity from suppliers to end-users is also discussed, emphasising the need for scientifically based validation of cleanroom garments, including gloves, and the importance of integrity testing to ensure filtration effectiveness and operator safety.
In conclusion, the presentation stresses the critical role of cleanroom garments as the primary barrier between operators and the cleanroom environment, highlighting the need for scientific evidence, validation of washing cycles, and integrity testing to maintain cleanliness standards and ensure patient safety in handling of pharmaceutical products.
Marc Mauro, International Sales Manager, PharmaMedia Dr.Müller GmbH
Abstract
Microbiological culture media is used for more than 100 years, however, rapid methods are much more recent. Several fields are concerned in the pharmaceutical industry: Research and development, Bioburden, Sterility testing and Environmental monitoring. Rapid methods represent a large variety of modifications in regards to the traditional culture method: composition of the medium (chromogenic), format (liquid, solid, cartridge…),
incubation conditions (automated, time, temperature), and reading (use of automatic readers). This presentation will focus on the available methods and trends for automatic readout of culture media for environmental monitoring, their advantages and limitations to increase in productivity and safety while reducing operation time in full compliance with Annex 1.
Thursday 22 May 2025
Agenda subject to change. More speakers will be announced in the coming weeks.
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Take a look at the exhibitor stands, network and meet industry peers
Tim Triggs, Consultant at Contamination Control/Air Technique International
Abstract: Cleanroom Technology – Testing Requirements and Technician Certification
Cleanrooms are essential environments in pharmaceuticals, healthcare, biotechnology, and technology, aerospace and automotive manufacturing, where stringent contamination control is required. This presentation explores the fundamental principles of cleanroom technology, with a particular focus on the testing requirements for different cleanroom classifications, including ISO 14644 standards, EU GMP and other industry best practices.
Key testing procedures such as airborne particle counting, airflow measurements, filter integrity tests, pressure differentials, and environmental monitoring will be discussed. Additionally, the presentation highlights the importance of technician training and certification, particularly through the Cleanroom Testing and Certification Board International (CTCB-I), which provides structured education and credentials for professionals in the field.
Steve Marnach, EMEA Training Manager & Specialist at DuPont
Abstract
The new GMP Annex 1, which took effect in August 2023, changed the requirements on manufacturers of sterile medicine products due to its new approach. It is expected that all the activities inside the pharmaceutical manufacturing are governed holistically by the QRM principles and documented in the contamination control strategy (CCS). Since cleanroom garment systems are a critical part of sterile and aseptic manufacturing and the only filter to keep the particles generated by the operators inside the garments to prevent them from contaminating the cleanroom, they should be managed under QRM principles too. In other words, simply relying on experience, visual checks and recommendations from the suppliers is not enough any longer. This raises the question on how cleanroom garments should be selected and validated under QRM principles to become a part of the CCS.
Andrew Wert, Founder President, CertAir
Abstract
The session will:
Provide qualitative and quantitative examples of current cleanroom certification practices and their limitations.
Demonstrate how robotics enhance precision and reproducibility, achieving full NIST-level traceability.
Highlight innovative approaches by leading companies such as Micronview, SmartCleanroom Solutions, and CertAir, which are delivering robotics and AI solutions to the market.
Showcase unique industry partnerships driving advancements in hardware, AI, AR, and software capabilities including near real-time airflow simulations and optimization models.
Matthias Angelmaier, Global Technology Partner at Pharma Plan
Abstract
Robotic applications are getting a more important aspect to reduce or best eliminate manual interventions in aseptic fill finish. The usage of robotic systems in pharma is not a new trend. Especially for supporting processes around fill-finish in the cleanrooms, the first applications had already been developed and implemented in the 1990’s. This presentation gives an overview on some of the realised solutions over the years and how they evolved in terms of aseptic design and GMP. In addition, there is a focus on the main requirements that need to be addressed in the grade A environment of RABS and Isolator systems and how different vendors realise those. As a summary, upcoming challenges that are still seen for robotic applications are demonstrated including possible solutions and upcoming trends.
Jo Fabb, Senior Manager, Product Marketing at Ansell
Abstract
Presentation will explore the vital distinctions between surgical and cleanroom gloves, emphasising why surgical gloves are unsuitable for cleanroom environments. It will delve into the unique requirements of cleanroom settings, including contamination control, material compatibility, and regulatory standards, to highlight how cleanroom gloves are specifically designed to meet these demands. Additionally, the session will compare reusable and disposable cleanroom garments, explaining how both options fulfill essential protective functions while showcasing the
fundamental differences in their performance, sustainability, and operational impact.
Jason Kelly, Applications Director at Lighthouse
Abstract
Pharma 4.0 integrates digital technologies like AI, IoT, and automation to improve pharmaceutical manufacturing, quality, and efficiency, while enhancing compliance and real-time decision-making.
Environmental Monitoring data is critical for making decisions about the sterility of batches manufactured in today’s aseptic cleanroom environments and above all the safety of injectable products for patients.
Our presenter will provide an overview of how to go from Paper-Based labor-intensive, error prone systems to real time digital solutions for EM particle count data and the multiple LIMS and intermediate digital based systems available to go fully digital.
Digital data from cleanroom environmental monitoring is key for continuous manufacturing and to move into the Industry 5.0/Pharma 5.0 space. It enables real-time detection of issues, predictive maintenance, and improved compliance, while supporting
automation and AI-driven decision-making. This data ensures proactive contamination control, enhances product quality, and drives innovation in human-AI collaboration for smarter, safer pharmaceutical production.
Haşim Solmaz, President at ICCCS and General Manager at Lighthouse Worldwide Solutions
Abstract:
Cleanroom environments play a critical role in cleanrooms, ensuring product integrity, regulatory compliance, and patient safety. However, contamination remains one of the most significant risks in controlled environments, leading to costly recalls, regulatory non-compliance, and production inefficiencies. This session will explore the essential principles of effective cleanroom monitoring and highlight best practices to minimize contamination risks.
The presentation will cover:
What Cleanroom Monitoring IS and IS NOT – Clearing common misconceptions.
Cleanroom Classification vs. Cleanroom Monitoring – Understanding the key differences.
EMS vs. BMS: Why Environmental Monitoring Systems are NOT the same as Building Management Systems.
Key Contamination Control Strategies – Implementing real-time monitoring, risk-based sensor placement, and proactive response systems.
Regulatory Expectations & Compliance – Best practices in alignment with ISO 14644, EU GMP Annex 1, and FDA guidelines.
Case Studies & Lessons Learned – Insights from contamination incidents and success stories in pharmaceutical cleanrooms.
Attendees will gain a clear understanding of how to implement an effective cleanroom monitoring strategy that ensures continuous compliance, enhances process efficiency, and prevents costly contamination events.