Cleaning Technologies for Bioprocessing Systems

Cleaning technologies, including Clean-In-Place (CIP) Technology, are a vital part of biopharmaceutical manufacturing facilities and systems. Many different approaches can be and have been used in the design of biopharmaceutical process systems such that they may be cleaned by CIP means. Review the principles and practices of the application of CIP technology to bioprocess systems including considerations for compliance and validation.

Course Directors

Dale A. Seiberling, Principle, Electrol Specialties Company

• BS in dairy technology, Ohio State University
• MS in dairy technology, Ohio State University
• Registered Professional Engineer, Wisconsin
• Seiberling started a lifetime of work in CIP Technology when he joined Klenzade products in 1957 as engineering consultant. As early as 1974, he designed a CIP able process for large volume IV solutions. He formed Seiberling Associates in 1976 as principal and director of engineering. Seiberling applied some of the first CIP systems in the pharmaceutical industry to a lipids process, a sterile albumin process, and a blood fractionation process, with all of the piping and controls accomplished prior to the Dairy Standards. Intensive work on both pharmaceutical and biotech processes followed from 1987 onward. He has guided the design of many successful CIP applications for processes for IV solutions, blood fractionation, oral medications, and the full range of bioprocess operations including fermentation, downstream processing and dry products. He participates in 3-A Sanitary Standards work with other food equipment manufacturers.

John Hyde – Chairman, Founder and CEO, JM Hyde Consulting, Inc.

• BS in food science, The Ohio State University
• BS in business administration, The Ohio State University
• MS in food engineering science, The Ohio State University
• Mr. Hyde founded JM Hyde consulting in 1993 and the firm has grown to over 90 engineers and scientists specializing in process and control systems engineering, process and equipment validation, and compliance consulting for biopharmaceutical and pharmaceutical manufacturing facilities. He had additional experience at Synergen, where he worked for 2 years, with design, start-up and validation of key process systems and the overall responsibility for the cleaning validation programs for the firm’s large scale and clinical manufacturing facilities. Mr. Hyde also has process and CIP engineering experience with Seiberling Associates where he worked for 10 years.

Bioprocessing Overview Icon
A (B) next to a course description indicates that it is part of the “Bioprocessing Overview.”

Monday, May 21

08.30 - 09.30
Biopharmaceutical Cleaning Technologies: A View from the Past into the Future (B)
Dale Seiberling, Principle, Electrol Specialties Co.

09.30 - 10.30
Cleaning Engineering Principles (B)
Samuel Lebowitz, Technical Services Manager,
Electrol Specialties Company

11.00 - 12.00
Cleaning Mechanisms and Agents for Biopharmaceutical Process Residues (B)
John M. Hyde, Chairman, Founder and CEO, JM Hyde Consulting, Inc.

13.00 - 15.00
Components, Configuration, and Operational Strategies for Automated Cleaning (B)
Dale Seiberling, Principle, Electrol Specialties Co.

15.30 - 17.00
WORKSHOP: Bioprocess Systems and Equipment Specification, Procurement, and Installation
Sami Ismaili, Project Manager, Central Engineering Biotech Projects, Merck and Company
John McGee, Senior Process Engineer, Vaccine Process Engineering, Merck and Company

Tuesday, May 22

08.30 - 09.30
CIP Spray Devices: Effective Specification,
Application, and Validation (B)
John M. Hyde, President and Founder, JM Hyde Consulting, Inc.

09.30 - 15.00
Design of Biopharmaceutical Process Systems for Best Practices of CIP Technology (B)
Dale Seiberling, Principle, Electrol Specialties Co.
John M. Hyde, Chairman, Founder and CEO,
JM Hyde Consulting, Inc.

15.30 - 16.30
Cleaning Strategies for Typical Biopharmaceutical Process Systems (B)
John M. Hyde, President and Founder, JM Hyde Consulting, Inc.

Wednesday, May 23

08.30 - 10.00
Facility Design and Project Life Cycle (B)
Considerations for a CIP-able Process Johannes R. Roebers, Senior Director of Engineering, Genentech

10.30 - 12.00
Application of CIP Technology to a Vaccine Manufacturing Facility
Peter Watler, Vice President, West Coast Operations, JM Hyde Consulting, Inc .

13.00 - 14.30
Cleaning Systems Considerations in the Design and Construction of a Large-Scale Multiproduct Biopharmaceutical Manufacturing Facility (B)
Steve Sharon, Senior Manager, Corporate Process Engineering, Genentech, Inc.

15.00 - 16.30
Managing an Effective CIP Commissioning and Validation Project: An Experience Based Approach
Marcela Goodnight, Manager, enentech, Inc.

Thursday, May 24

08.30 - 12.00
Cleaning Compliance Comments and Observations: Recent FDA Perspectives (B)
John M. Hyde, Chairman, Founder and CEO, JM Hyde Consulting, Inc.

10.30 - 12.00
Cleaning Validation Strategies for Biopharmaceutical Manufacturing Facilities
John M. Hyde , Chairman, Founder and CEO, JM Hyde Consulting, Inc.

13.00 - 14.30
Cleaning Compliance Comments and Observations: Recent Manufacturing Perspectives (B)
Steve Reich, Senior Manager, Wyeth Biopharma

15.00 - 16.30
Are Your Cleaning Systems cGMP Compliant? Methodologies for Making an Assessment (B)
Simon Forder, Director, JM Hyde Consulting, Inc.