Course Description

Quality Critical Cleaning and Cleaning Validation Processes

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Course ID 1867

In-Person Course

Who Should Attend?
The course is intended for professionals in the development and manufacture of medical devices, pharmaceuticals, food products, and related fields. Disciplines include:

  • Research and development
  • Design/process engineering
  • Safety/environmental
  • Final assembly
  • Contract manufacturing
  • QA/validation

Course Description
This 3-day accredited course teaches principles and practice of critical cleaning and cleaning validation in life-science applications. The emphasis is on medical devices (single use and reusable) and pharmaceutical applications. Critical product cleaning is distinct from sterilization. Failure to clean properly can pose risks in such applications as pharmaceuticals, medical devices, and food processing.

The program provides approaches to cGMPs for critical cleaning processes that integrate the factors of chemistry, equipment and process methods, and that also consider regulatory and economic issues. A successful cleaning process utilizes the 4Ds: define, develop, document, and defend. The course also addresses challenges and standards/guidance development for applications where residues are adherent or are difficult to access or detect. We encourage interaction during the course; and participants are encouraged to provide examples of “pain points” and nagging problems.

Course Director
Barbara Kanegsberg; President, BFK Solutions, LLC and Ed Kanegsberg, PhD; Vice President , BFK Solutions, LLC

Barbara Kanegsberg, President of BFK Solutions, LLC, is a recognized expert in critical/industrial cleaning and contamination control. Her education and professional background includes biology, clinical chemistry and aerospace. She develops critical cleaning processes, conducts validations, and resolves product-related regulatory issues. As a member of the ASTM medical device Cleanliness Testing Task Force, she takes an active role in development of standards and guidance documents including “Guide for Validating Cleaning Processes for Medical Devices” (F3127-2016). Ms. Kanegsberg is an appointed United States Expert to ISO/TC 209 WG 12: “Cleaning of surfaces to achieve defined levels of cleanliness in terms of particle and chemical classifications.” She has a master degree in biological chemistry.

Ed Kanegsberg, PhD, Vice President of BFK Solutions, is a chemical physicist and engineer who troubleshoots and solves manufacturing production problems. He is a recognized advisor and consultant in industrial cleaning process design and process performance. He expedites projects in medical device development and in other high-value product. He has decades of experience in physics and engineering, specializing in the transition of products from prototype to production. He moderated a session at the 2014 FDA workshop on Additive Manufacturing of Medical Devices. Mr. Kanegsberg has a doctorate in physics.

The Kanegsbergs are the industry leaders in critical cleaning. As independent consultants, they work with manufacturers of high-value product, including medical device manufacturers and their suppliers. They publish extensively, lecture at the post-graduate level, and teach practicing engineers and manufacturers. They are co-editors of and contributors to the two-volume “Handbook For Critical Cleaning,” second edition, CRC Press, 2011.

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