Location: Virtual | 10 - 11 a.m. ET*
EU GMP Annex 1 requires aseptic processes for the sterilization of indirect product contact surfaces. Based on the design of restricted-access barrier systems (RABS) and isolators, certain indirect contact surfaces are built-in or very heavy, which would require a significant redesign of existing lines.
Each facility must apply a strategic approach to understand the risk of contamination and develop appropriate measures that support a comprehensive Contamination Control Strategy.
This webinar reviews contamination control measures for three techniques: cleaning and disinfecting, cleaning and biodecontaminating or cleaning and sterilizing to prevent contamination of stopper bowls that can or cannot be dismantled from a RABS or an isolator. Our presenters introduce a risk-based approach, comparing situations where a stopper bowl can and cannot be dismantled.
Further, this webinar proposes measures to mitigate contamination risk for aseptic areas and confirm contamination control in all situations.
* Please note that the webinar broadcast time is listed in the Eastern Time Zone (ET). If necessary, be sure to convert to your local time zone.
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Meet the Presenters
Walid El Azab | Senior Manager, Technical Services
Walid has over a decade 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.
Cecilia Pierobon | Technical Service Manager
Cecilia has over four years of experience in the qualification of pharmaceutical equipment for production and laboratory environments, Good Manufacturing Practices (GMP) and regulatory compliance. Cecilia holds a master’s degree in engineering management.
Prior to joining STERIS Life Sciences, Cecilia worked as a Project Engineer at Ellab and a GMP Compliance Specialist at Catalent.
At STERIS Life Sciences, Cecilia provides global technical support to Customers on cleaning validation, the development of cleaning cycles and cleaning chemistry applications. She also conducts technical presentations at industry events and develops technical literature.
Cecilia is an active member of the International Society for Pharmaceutical Engineering (ISPE) and the Parenteral Drug Association (PDA).