Cleaning Validation: important phases in the development of the cleaning process

Cleaning Agent Selection and

Implementing a New Cleaning Process Approach

Sponsored By:
Hyde Engineering + Consulting, Inc.


Wednesday, January 20, 2016

4:00 – 7:00 pm


Baxalta (Baxter Healthcare)

Save the date:  GMP EXPO May 26  Brouwerji West


Program Managers:   
Paul Crissman, Biotechnical Solutions
Dona Tseng, Baxalta


Paul Lopolito, Manager Technical Services, STERIS Corporation
Keith Bader, Sr. Director of Technology, Hyde Engineering + Consulting, Inc.
4:00 – 5:00 pm
Registration, Networking and Dinner
5:00 -6:00 pm   
Paul Lopolito, Manager Technical Services, STERIS Corporation
Cleaning Agent Selection and Considerations
Cleaning agent screening will include a review of the cleaning chemistry, rinsability, toxicity, environmental impact, safety considerations, supplier assessment, stability of the formulation and packaging, performance, and technical support.
6:00 –7:00 pm
Keith Bader, Sr. Director of Technology, Hyde Engineering + Consulting, Inc.
A Step-wise Approach to Developing a New Cleaning Process
Cleaning processes are often developed late and out of phase with overall process development, resulting in ineffective cleaning methods. Further, the requisite rigor for development is quite frequently neglected in favor of legacy methods and tribal knowledge employed for other products without concern for the unique properties and considerations presented by new products.
This presentation discusses a phased approach that may be employed for the development of critical cleaning process parameters at the bench scale and the translation of those parameters to pilot and manufacturing scale operations. Specifically, important phases in the development of the cleaning process include, residue characterization, cleaning agent selection, cleaning process design space exploration, chemical wash phase duration estimation, and scale-up.

About the Speakers

Paul Lopolito, Manager Technical Services, STERIS Corporation
Paul provides global technical support related to process cleaning and contamination control, which includes field support, site audits, training presentations and educational seminars. He is a frequent speaker at industry events including the PDA, ISPE, INTERPHEX, ACHEMA, AALAS, and IVT. He manages the Process and Cleaner Evaluation, PACE® Program to develop and improve critical cleaning processes.
He was previously the Manager, Manufacturing Technical Services for University of Massachusetts Medical Center Biological Labatories, where he managed cross-functional teams supporting manufacturing process changes and cleaning validation. Coordinated the technology transfer of new equipment, procedures and documentation into manufacturing. Coordinate/author the development of validation protocols; oversee execution of validation studies; review data and author final reports. Lead investigation and root cause determination of complex technical process issues. Author change controls and planned deviations to support process changes and validation. Prior to that he was the Manufacturing Manager at TEI Biosciences Inc. (Formerly Tissue Engineering Inc).
Keith Bader, Sr. Director of Technology, Hyde Engineering + Consulting, Inc.
Keith holds a Bachelor of Science degree in Chemical Engineering from the University of Colorado at Boulder.  He began his career conducting government contract research in catalysts and advanced materials through SBIR grants.  Following that, he joined Hyde Engineering + Consulting, Inc. in 1999 and worked in a variety of areas from control system development to cleaning validation.  Through the years, he has provided high level consultation to Hyde’s Engineering’s clients in topic areas ranging from strategic quality and validation documentation architecture to detail oriented support such as design of experiments and supporting study design.  Specific areas of focus for Keith have included the implementation of online instrumentation and process analytical technologies for clean-in-place systems, as well as the translation of bench scale cleaning process development data to full scale manufacturing systems.  Leveraging this expertise, Keith founded Hyde’s CORE Lab, a facility devoted to the development, exploration, and scale up of cleaning processes for the pharmaceutical and biopharmaceutical industries.
Keith has also published multiple journal and periodical articles as well as a chapter in “PAT Applied in Biopharmaceutical Process Development and Manufacturing: An Enabling Tool for Quality-by-Design” by Duncan Lowe, and another in “Cleaning and Cleaning Validation, Volume 2,” edited by Dr. Paul Pluta.  Keith is currently a member of the International Society for Pharmaceutical Engineering (ISPE), American Institute of Chemical Engineers (AIChE), and the Parenteral Drug Association (PDA).
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