About Us
Microbiology Consultant
There are a number of Microbiology Consultants with much in the way of theoretical knowledge, not many of whom have spent much time lately in the trenches of day-to-day testing, evaluation and investigation of microbiology data.
MicroGuard Consulting, LLC was formed to fill the need for expertise in the field of Pharmaceutical Microbiology that comes from a long and recent immersion in the testing of raw materials, excipients, in-process materials, down-stream process intermediates and finished products for sterile and non-sterile dosage forms.
The Principal Microbiology Consultant, Robert F. Guardino, comes from a deep and varied career in Biotechnology, Microbial Diagnostics, and Pharmaceuticals. MicroGuard Consulting offers practical solutions to microbiology contamination, control and compliance issues faced by Pharmaceutical and Biotechnology Companies.
Principal Consultant Biography
Robert F. Guardino, M.S.
Principal Microbiology Consultant
MicroGuard Consulting, LLC
4837 Wedgefield Drive
Wilmington, NC 28409
(Cell) 910-616-0066
E-mail: rfg@microguardconsulting.com
Mr. Guardino is the founder and principal microbiology consultant for MicroGuard Consulting, LLC. MicroGuard exists to assist the Pharmaceutical and Biotechnology industries with microbiological compliance and contamination and control issues.
Education & Training
Prior to this role Mr. Guardino served as the Director of the Microbiology Lab for AAIPharma Services Corp. where he managed a full-service contract Microbiology Laboratory in support of the Pharmaceutical and Biotechnology industries. In this role Mr. Guardino interacted with many clients and client companies offering consulting and testing services.
After earning a Master of Science Degree from the University of Buffalo in Medical Technology with a concentration in Microbiology, he performed research in Microbiology and Biotechnology for several years and supervised an industrial microbiology lab for five years.
Mr. Guardino has also held positions as a product development / quality assurance supervisor for rapid microbial diagnostic products and as a principal scientist during the development of PCR-based diagnostic products for a JNJ Company. His Quality System / Good Manufacturing Practice Regulations experience span 20 years.
Expertise
Areas of expertise include microbial contamination and control; microbial specifications for non-sterile and sterile dosage forms; drug substance, excipient, in-process and finished product microbiological testing requirements; release and stability requirements and testing strategies; down-stream / purification process contamination and control for biotechnology products; disinfectant qualification; water system and environmental validation.
He has presented seminars and workshops domestically and internationally on the theory and practice of microbiology testing, including training for FDA CDER and CBER branches.
