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.
Download Annex 1 FAQs Document
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.
Presenter: Walid El Azab – Senior Manager, Technical Services
Watch Contamination Control Webinar Recording
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.
Presenters: Walid El Azab – Senior Manager, Technical Services | Matt Hofacre – Director, Application Project Management
Watch Environmental Compliance Webinar Recording
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.
Presenters: Paul Lopolito – Senior Manager, Technical Services | Olivier Van Houtte – Senior Product Marketing Manager
Watch Product Contact Sterilization (Part 1) Webinar Recording
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.
Presenters: Aaron Mertens – Senior Manager, Technical Services | Juha Mattila – Director, Sterilization Technologies
Watch Product Contact Sterilization (Part 2) Webinar Recording
Annex 1 Panel Discussion
Meet Our Presenters
Our webinar presenters have extensive knowledge of GMPs and experience helping manufacturers enhance their contamination control strategies.
Walid El Azab | Senior Manager, Technical Services
Walid has more than 13 years of experience as an industrial pharmacist, providing technical support for upstream and downstream pharmaceutical operations with experience working at multiple pharmaceutical and biotechnology organizations prior to joining STERIS Life Sciences eight years ago. He delivers expertise in cleaning, disinfectants, sterility assurance and process validation and is an active member of PDA, ISPE, ECA and A3P. He is a Qualified Person and has a master’s degree in pharmaceutical engineering. He is an active member of Annex 1 working groups and leads the ECA task force on contamination control strategy.
Paul Lopolito | Senior Manager, Technical Services
Paul has over 20 years of industry experience in pharmaceutical manufacturing and laboratory research settings. He currently provides global technical support related to process cleaning, cleaning validation, and contamination control, which includes field support, site audits, training presentations and educational seminars. Paul is a frequent speaker at industry events and has published several articles and book chapters related to cleaning validation and contamination control.
Matt Hofacre | Director, Application Project Management
Matt has over 23 years of experience in the life sciences pharmaceutical/biopharmaceutical production, food and beverage, medical device and laboratory research industries. His team assists STERIS Life Sciences Customers with design applications, project maintenance and technical guidance for integrated Vaporized Hydrogen Peroxide (VHP) systems. Matt is a presenter and trainer at national and international conferences, including PDA, ISPE and ASME. He co-authored “PDA Technical Report No. 48 Moist Heat Sterilization Systems: Design, Commissioning, Operation, Qualification and Maintenance” and contributed to numerous other articles on water for injection (WFI) systems, VHP and pharmaceutical equipment selection.
Juha Mattila | Director, Sterilization Technologies
Juha has over 20 years of experience in pharmaceutical, research and biosafety technologies, managing the STERIS Life Sciences portfolio of products for Vaporized Hydrogen Peroxide (VHP) and steam sterilization, material transfer biodecontamination technologies, as well as WFI and pure steam generation systems. He is an active member of PDA, ISPE and the Finnish Biosafety Network and has authored several technical articles and spoken at many industry events. Juha also contributes to ISO, CEN and BSI standard work groups considering these technologies. He has a bachelor’s degree in HVAC and process engineering and a master’s degree in engineering in business informatics. He provided the STERIS Life Sciences Equipment and Services commentary responses through PDA to the EU Annex 1 draft in 2020 and participated in the PDA EU Annex 1 workshop in 2022.
Aaron Mertens | Senior Manager, Technical Services
Aaron is a microbiologist with 20 years of experience in pharmaceutical manufacturing, with expertise in cleaning, disinfection, sterilization and contamination control. He has held several positions within the pharmaceutical industry, with experience working at pharmaceutical manufacturing organizations representing quality assurance programs and working with global industry regulatory agencies. Aaron has a bachelor’s degree in genetics and is an active member of PDA and ISPE. He is also the past president of the ISPE Great Lakes chapter.
Olivier Van Houtte | Senior Manager, Product Marketing
Olivier has 11 years of experience managing the STERIS Life Sciences portfolio of products for GMP and research washer and steam sterilization technology. Olivier holds a bachelor’s degree in business-marketing from Quebec University in Canada. He is an active member of ISPE and PDA and has published articles and spoken at industry events.