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
Paul has over two decades of industry experience in pharmaceutical manufacturing and laboratory research settings, with expertise in process cleaning, cleaning validation and contamination control.
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He holds a bachelor’s degree in biological sciences.
At STERIS Life Sciences, Paul provides global technical support through field consultations, site audits, training presentations and educational seminars. He also manages the Process and Cleaner Evaluation (PACE™) program and analytical testing laboratory, which simulate Customer cleaning processes and support analytical method development and validation.
Paul is experienced in managing cross functional projects related to process cleaning and critical environment operations, with direct experience in the biopharmaceutical and biomedical device industries. He is a frequent speaker at industry events and has published several articles and book chapters related to cleaning validation and contamination control. He is also 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 industry experience, with expertise in 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.
At STERIS Life Sciences, Matt supports global Customers, regulatory and industry groups with consulting and technical guidance for contamination control strategies and sterilization applications. His areas of specialization include Vaporized Hydrogen Peroxide (VHP™) biodecontamination, VHP sterilization, moist heat sterilization, pharmaceutical and laboratory washing systems, pure steam production, purified water systems, and equipment services. He is also a dedicated student of lean methodologies, focusing on maximizing value for Customers through streamlined processes.
Matt is an active member of the Parenteral Drug Association (PDA), the Association for the Advancement of Medical Instrumentation (AAMI) and the International Society for Pharmaceutical Engineering (ISPE). He serves as a PDA course instructor and participates in the ISPE Mentoring Program. His industry contributions include co-authoring PDA Technical Report No. 48: Moist Heat Sterilization Systems: Design, Commissioning, Operation, Qualification and Maintenance, as well as authoring and contributing to numerous publications on biodecontamination, sterilization, washing technologies, water for injection systems and pharmaceutical equipment selection.
Juha Mattila
Juha has over two decades of experience in pharmaceutical, medical device, research and biosafety technologies, with expertise in moist heat and Vaporized Hydrogen Peroxide (VHP™) sterilization, VHP biodecontamination technologies and Water-for-Injection (WFI) distillation and pure steam systems.
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He holds a master’s degree in business informatics and a bachelor’s degree in heating, ventilation and air conditioning (HVAC) and process engineering.
At STERIS Life Sciences, Juha serves as a Senior Manager of Technical Services for sterilization applications, equipment and critical utilities technologies. He provides technical leadership across sterilization and biodecontamination systems and supports global Customers with complex equipment and utility related needs.
Juha is an active member of the Parenteral Drug Association (PDA), a Nordic Board member for the International Society for Pharmaceutical Engineering (ISPE) and a member of the Finnish Biosafety Network. He has authored several technical articles and presented at numerous industry events. He also contributes to standards development through involvement with the International Organization for Standardization (ISO), the European Committee for Standardization (CEN), the Finnish Standardization Organization (SFS), ASTM International and the British Standards Institution (BSI). Juha also 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 industry experience in pharmaceutical manufacturing, with expertise in cleaning, disinfection, sterilization and contamination control. He has held several positions within the pharmaceutical industry, representing quality assurance programs and collaborating with global regulatory agencies.
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He holds a bachelor’s degree in genetics.
At STERIS Life Sciences, Aaron leads the global Technical Services team, which includes scientists such as chemists, biologists and microbiologists. In addition to his leadership responsibilities, he plays a critical role in evaluating and consulting global manufacturing sites to ensure compliance with international regulations. He also provides global technical support for critical environments, sterility assurance and sterility maintenance applications and validations.
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. His professional contributions also include posters, publications, virtual and live technical presentations and leading global sterilization master classes.
Olivier Van Houtte
Olivier has over a decade of industry experience, with expertise in product portfolio management for Good Manufacturing Practices (GMP) and research washer and steam sterilization technologies.
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He holds a bachelor’s degree in business marketing.
At STERIS Life Sciences, Olivier is responsible for developing long-term vision and strategy for several product lines, as well as the tactics required to implement that vision. He also oversees new product and market development, monitors evolving industry standards and regulations and provides product training to support company objectives.
Olivier is an active member of the International Society for Pharmaceutical Engineering (ISPE) and the Parenteral Drug Association (PDA). He has coauthored several articles featured in scientific publications and has spoken at industry events for 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