STERIS presents a series of webinars that equip medicinal drug product manufacturers and industry stakeholders with information to better manage compliance with the newly released revision of EU GMP Annex 1 in contamination control strategy (CCS) development and documentation.
The presented topics cover a range of process activities, including identification of contamination risks and mitigation strategies critical for compliance with Annex 1. Additionally, the webinars present opportunities for quality and productivity improvement.
Annex 1 FAQs
To comply with Annex 1, pharmaceutical manufacturers are required to identify, review and update critical controls to ensure holistic confidence in the measures implemented for contamination prevention.
STERIS Life Sciences has answered a list of frequently asked questions related to implementation and evaluation of a contamination control strategy for Annex 1 compliance.
On Demand Webinars
Implementation of a Contamination Control Strategy for Compliance with Annex 1
This webinar presents an overview of the contamination control strategy (CCS) process in a medicinal production facility. We introduce the European Compliance Academy (ECA) template as a tool for documenting the CCS process with examples of elements to consider, including cleaning, decontamination, sterilization and sterility maintenance.
The webinar also covers an overview of Annex 1 changes in contamination control and a discussion of challenges manufacturers may face with the holistic CCS approach. We discuss how to leverage modern technology (e.g., software, virtual reality) and statistical analysis to overcome these challenges. Finally, attendees will participate in a survey to share their experience and benchmark status regarding Annex 1 implementation.
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Environmental Cleaning, Decontamination, Biodecontamination and Disinfection for Compliance with Annex 1
This webinar focuses on environmental contamination control measures, including cleaning, decontamination, biodecontamination and disinfection as they relate to Annex 1 requirements.
We begin by identifying common contamination sources in cleanrooms and during production by walking through a generalized production process. Then, we present the elements to consider before designing contamination control measures for cleanrooms, material transfer, aseptic suites, critical utilities and process equipment.
The webinar includes a discussion of Vaporized Hydrogen Peroxide (VHP) as a decontamination modality in the Annex 1 framework. Finally, we review the risks associated with insufficient cleaning after implementing environmental disinfection measures, advising the manufacturer of a suitable set of controls to ensure effective contamination control.
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Cleaning and Sterilization of Product Contact Equipment for Compliance with Annex 1 – Part I
Medicinal product manufacturers must evaluate the maintenance of product contact equipment through cleaning and sterilization as part of a contamination control strategy (CCS). This two-part webinar focuses on Annex 1 requirements for critical product contact surfaces, including best practice recommendations for sterility assurance compliance.
Manufacturers can optimize the cleaning process within automated equipment washers and the sterilization process within autoclaves for production efficiency while meeting the Annex 1 requirement to minimize the risk of contamination.
To cover cleaning and sterilization of product contact equipment, the two-part webinar walks through an example “life cycle” of product contact equipment, identifying potential contamination risks and mitigation solutions. This demonstrates best practices for achieving compliance with Annex 1. The steps included in Part I of this webinar are product contact equipment washing and pre-sterilization wrapping.
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Cleaning and Sterilization of Product Contact Equipment for Compliance with Annex 1 – Part II
Part II of this webinar carries forward in the cleaning and sterilization “life cycle” of product contact equipment, focusing on sterility maintenance through wrapping, sterilization, transport, storage and aseptic presentation. We discuss potential contamination risks and mitigation solutions at each step of the life cycle.
Additionally, the webinar reviews terminal product sterilization using Vaporized Hydrogen Peroxide and how it meets requirements for repeatability and reliability.
To conclude, the webinar demonstrates best practices for achieving compliance with the revised regulation by defining the contamination risks and identifying appropriate controls for critical surfaces.
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Annex 1 Panel Discussion
STERIS subject matter experts conclude the “Navigating Annex 1” webinar series with a highly interactive panel discussion that reviews the key changes within the newly released EU Annex 1 and recommendations for compliance with the changes.
The discussion recaps the contamination control strategy holistic approach principles and elements to consider when documenting your contamination control strategy.
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Meet the Presenters
Paul Lopolito
With over two decades of industry experience in pharmaceutical manufacturing and laboratory research settings, Paul provides global technical support for process cleaning, cleaning validation and contamination control, which includes field support, site audits, training presentations and educational seminars.
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He holds a bachelor’s degree in biological sciences.
Prior to joining STERIS Life Sciences, Paul spent three years as a Manufacturing Technical Services Manager at Massachusetts Biological Laboratories providing technical support and project management for the vaccine, monoclonal antibody, blood product and filling/packaging groups. He also spent time at TEI Biosciences, where he held positions of Research Associate, Laboratory Manager and Manufacturing Manager.
Paul manages the Process and Cleaner Evaluation (PACE™) program and analytical testing laboratory for STERIS Life Sciences, which simulates a Customer’s cleaning process to make recommendations for improvements and analytical method development and validation. He has expertise in managing cross-functional projects related to process cleaning and critical environment operation with direct experience in the biopharmaceutical and biomedical device industries.
Paul is a frequent speaker at industry events and has published several articles and book chapters related to cleaning validation and contamination control. He is an active member of the International Society for Pharmaceutical Engineering (ISPE) and the Parenteral Drug Association (PDA).
Matt Hofacre
Matt has over two decades of experience providing sterilization, biodecontamination, water, steam and washing applications for the biopharmaceutical, medical device, food and beverage, biological containment and laboratory research industries.
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He holds a master’s degree in finance and marketing and a bachelor’s degree in chemical engineering.
For STERIS Life Sciences, Matt supports global Customers, regulatory and industry groups with consulting and technical guidance for contamination control strategies and sterilization applications. Related technologies include Vaporized Hydrogen Peroxide (VHP™) biodecontamination, VHP sterilization, moist heat sterilization, washing, pure steam production, purified water systems and equipment services. He is also a student of lean practices to maximize value stream to Customers.
The Parenteral Drug Association (PDA), International Society for Pharmaceutical Engineering (ISPE), INTERPHEX, ACHEMA and American Society of Mechanical Engineers (ASME), amongst others, have welcomed Matt as a presenter and trainer at several national and international conferences.
Matt co-authored PDA Technical Report No. 48 Moist Heat Sterilization Systems: Design, Commissioning, Operation, Qualification and Maintenance and has authored and contributed to numerous other articles on water for injection systems, steam sterilization, VHP and pharmaceutical equipment selection.
Juha Mattila
Juha has over two decades of experience in pharmaceutical, medical device, research and biosafety technologies.
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At STERIS Life Sciences, he is a Senior Manager of Technical Services for sterilization applications, equipment and critical utilities technologies. Juha’s expertise covers moist heat and Vaporized Hydrogen Peroxide (VHP™) sterilization, VHP biodecontamination technologies and Water-for-Injection (WFI) distillation and pure steam systems. He holds a master’s degree in business informatics and a bachelor’s degree in heating, ventilation and air conditioning (HVAC) and process engineering.
In addition to being an active member of the Parenteral Drug Association (PDA), Nordic Board member for the International Society for Pharmaceutical Engineering (ISPE) and the Finnish Biosafety Network, Juha has authored several technical articles and spoken at many industry events. He also contributes to the International Organization for Standardization (ISO), the European Committee for Standardization (CEN), Finnish Standardization Organization (SFS), American Society for Testing and Materials (ASTM) International and the British Standards Institution (BSI) work groups considering these technologies.
Juha coordinated the STERIS Life Sciences Equipment and Services commentary through the PDA for the European Union (EU) Good Manufacturing Practices (GMP) Annex 1 draft and participated in the PDA EU GMP Annex 1 Workshops in 2022 and 2024.
Aaron Mertens
Aaron has over two decades of experience in pharmaceutical manufacturing, with expertise in cleaning, disinfection, sterilization and contamination control.
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He has held several positions within the pharmaceutical industry, with experience working at pharmaceutical manufacturing organizations representing quality assurance programs and collaborating with global industry regulatory agencies. He holds a bachelor’s degree in genetics.
At STERIS Life Sciences, Aaron performs global manufacturing site evaluations and consultations to ensure compliance with international regulations. He is also responsible for providing global technical support for critical environments, sterility assurance and sterility maintenance application and validation.
Aaron is an active member of the Parenteral Drug Association (PDA) and the International Society for Pharmaceutical Engineering (ISPE). He previously served as President of the ISPE Great Lakes Chapter and is currently a member of the ISPE Sterile Products Processing Steering Committee.
Additional professional activities for Aaron include delivering technical content to the industry with posters, publications, virtual and live technical presentations, as well as leading global sterilization master classes.
Olivier Van Houtte
Olivier has over a decade of experience managing the STERIS Life Sciences portfolio of products for Good Manufacturing Practices (GMP) and research washer and steam sterilization technology. He holds a bachelor’s degree in business-marketing.
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At STERIS Life Sciences, Olivier is responsible for developing a long-term vision for several product lines and the strategies and tactics to implement that vision. He is also responsible for new product and market development, understanding the latest industry standards and regulations and providing product training to achieve company objectives.
He is an active member of the International Society for Pharmaceutical Engineering (ISPE) and the Parenteral Drug Association (PDA). Olivier has co-authored several articles that have been featured in scientific publications. He has also spoken at industry events for the ISPE, PDA and other associations.
Dedicated Scientific Support
Our technical services team, comprised of industry-recognized scientists and engineers, provides exceptional expertise in contamination control strategies, process optimization, regulatory compliance, validation support and quality assurance. Navigate complex regulatory landscapes, reduce operational risks and accelerate your time-to-market with support from our professionals.
Meet the Team