Pine Lake Laboratories is fortunate to have Dr. Michael Ruberto as a retained consult available to support all extractable and leachable studies.

Dr. Ruberto is the President of Material Needs Consulting, LLC  which provides consulting services to manage the development and commercialization of medical devices and packaging, with a special emphasis on material selection, extractables and leachables, and supply chain management.   He has been an active member of various pharmaceutical working groups that have developed “best practices” for characterizing and evaluating the safety of container closure systems and packaging for several different drug dosage forms.  Some of these teams include:

• PQRI Orally Inhaled and Nasal Drug Product E&L Working Group
• PQRI Parenteral and Ophthalmic Drug Product E&L Working Group
• United States Pharmacopeia (USP) Packaging and Storage Expert Committee

Dr. Ruberto was formerly the Head of Regulatory Services for the NAFTA region at Ciba Specialty Chemicals where he was responsible for worldwide notifications of new products, food contact notifications, and regulatory compliance of Ciba chemicals.    At Ciba Dr. Ruberto also served as the Director of Analytical Research.  Dr. Ruberto was employed by Ciba for fifteen years.

Dr. Ruberto received a B.S. with thesis from Stevens Institute of Technology and a Ph.D. in Analytical Chemistry from Seton Hall University.

To learn more about Dr. Ruberto, please visit www.materialneedsconsulting.com

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