Location: Virtual | 6 - 7 p.m. GMT+8
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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Meet the Presenters
Walid El Azab Senior Manager, Technical Services, has over 13 years of experience as an Industrial Pharmacist. He provides technical support for STERIS Life Sciences Customers for cleaning, disinfectants, sterility assurance, and process validation. Walid holds a master’s degree in pharmaceutical sciences and an additional master’s degree in industrial pharmaceutical sciences.
Areas of expertise for Walid include upstream and downstream pharmaceutical operation and validation in non-sterile and sterile processes. His previous experience includes project management, handling deviations and complaints, releasing raw materials, conducting external audits of suppliers, leading Customer and regulatory audits and developing strategies for process cleaning and system gap analysis.
As a member of the Technical Services team at STERIS Life Sciences, Walid supports Customers with the development of contamination control program, provides guidance on cleaning and disinfection and assists with the creation of technical literature.
Walid is an active member of the Parenteral Drug Association (PDA), the International Society for Pharmaceutical Engineering (ISPE), the European Compliance Academy (ECA) and the Association for Clean and Parenteral Products (A3P). He has published several articles and book chapters on contamination control. Walid has been involved in the creation of several industry guidelines, including CCS and derouging and passivation guidelines. He is also active with the A3P GIC working groups on sterilization, derouging and passivation, GMP Annex 1, and Contamination Control strategy. Walid is also part of the ECA EU GMP Annex 1 task force and leads the ECA task force on contamination control strategy.
Matt Hofacre Senior Director, Technical Services, has over 23 years of experience in pharmaceutical and biopharmaceutical production, advanced therapy medicinal product production, high containment, food and beverage, medical device and laboratory research industries. He holds a master’s degree in finance and marketing and a bachelor’s degree in chemical engineering.
For STERIS Life Sciences, Matt supports Customers globally with design applications, project maintenance and technical guidance for integrated Vaporized Hydrogen Peroxide (VHP), steam sterilization, washing, pure steam, water systems and services. He is a student of lean practices to maximize value stream to Customers.
The Parenteral Drug Association (PDA), the International Society for Pharmaceutical Engineering (ISPE) and the American Society of Mechanical Engineers (ASME) 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 contributed to numerous other articles on water for injection systems, VHP and pharmaceutical equipment selection.