Cleaning validation is the documented evidence that the cleaning procedure can effectively remove residue to an acceptable level to prevent cross-contamination. Having a validated cleaning program is of utmost importance to any GMP manufacturing facilities.
One of the critical steps in performing a successful cleaning validation is establishing the limits of residue that can remain on the surface being cleaned. Several factors can impact the selection and validation of these residual limits, such as product grouping, sampling technique, analytical methodology, and areas of non-uniform contamination. During the presentation, we will explore approaches to establish health-based exposure limits for cleaning validation by detailing the factors that are used in the limit calculation and then calculating the residue limits for a variety of dosage forms using accepted daily exposure (ADE) or permitted daily exposure (PDE) values.
This presentation highlights key elements of cleaning validation to enable a facility to stay compliant with current regulations with attention to setting health-based exposure limits.
The following topics will be discussed in detail during the presentation:
Paul Lopolito, Senior Technical Service Manager, STERIS Corporation
Paul Lopolito is a senior technical services manager for the Life Sciences Division of STERIS Corporation (Mentor, Ohio). 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 has over 25 years of industry experience and has held positions as a technical services manager, manufacturing manager and laboratory manager.
Richard Chai, Technical Service Manager, STERIS Corporation
Richard Chai is a Technical Service Manager in the Life Sciences Division of STERIS Corporation. He currently provides global technical support related to process equipment cleaning and contamination control in cleanrooms. Richard has more than 20 years of industry experience in manufacturing, validation, consultancy, and technical support. He has published several articles in contamination control and is a frequent speaker at industry events.