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Aseptic Solutions, Inc.SM is a consulting firm offering specialized solutions to pharmaceutical manufacturers relative to sterility assurance, aseptic processing and environmental control issues.  By reviewing and evaluating our clients' processes, we are able to work with them to define corrective actions, where warranted, and to assist them in preparing for regulatory inspections and/or responding to regulatory actions.  We offer "hands-on" testing and training in Cleanrooms, including airflow studies, velocity measurements and environmental sampling rationales. Located in Clayton, NC, ASI's sister company, Aseptic Training Institute (ATI), provides hands-on training in aseptic processing, microbiology in a state-of-the-science facility.



Key Personnel:

John M. Lindsay, President (click here to download Mr. Lindsay's full CV)

20 years management experience (28 years total experience) for three of nation's leading pharmaceutical companies.

Currently, President of Aseptic Solutions, Inc., a consulting firm specializing in consultation to parenteral pharmaceutical manufacturers on sterility assurance, aseptic processing and environmental control issues.

Currently, Executive Director of the Aseptic Training Institute in Clayton, NC. The Institute specializes in aseptic processing training to the pharmaceutival and biotechnology industries.

Formerly, Senior Consultant, KMI/PAREXEL, specializing in consultation to parenteral pharmaceutical manufacturers on sterility assurance, aseptic processing and environmental controls.

Also, Senior Process Engineer, coordinating all qualification/validation activities related to the expansion of a fluid-bed coating production facility for a potential half-billion dollar per year product.

Organized and directed all validation/qualification activities for equipment and critical systems (WFI, pure steam, HVAC, compressed air, nitrogen) for the start-up of a 17,000 square foot cleanroom facility.

Organized and directed all validation of new water-for-injection system approved on initial inspection by FDA while Head Microbiological Quality Assurance for veterinary pharmaceutical firm.

Co-author of Cleaning and Cleaning Validation: a Biotechnology Perspective, the first book published by the Parenteral Drug Association.

Co-author of PDA Technical Report No. 13, "Fundamentals of a Microbiological Environmental Monitoring Program."
Co-author of PDA Technical Report No. 35, "A Proposed Training Model for the Microbiological Function in the Pharmaceutical Industry."
Co-author of PDA Technical Report No. 62, "Recommended Practices for Manual Aseptic Processes."

Committee Member of PQRI Industry-FDA Joint Committee providing recommendations to the FDA on their Concept Paper on Aseptic Processing distributed publicly in August 2002.

Selected by National Registry of Microbiologists in 1989 as Chairman of Consumer and Industrial Microbiology Examination. Elected Chairman of the Board of the National Registry of Microbiologists in 1993 and held that leadership position until July 1999.

Participant on a PhRMA Task Force to establish an industry standard for the environmental control of bulk manufacturing processes for the Biologics and biotechnology industries.

Member of ISO/TC 209 Working Group 5 developing ISO 14644 "Cleanrooms and Associated Environments-Part 5: Operations."


Contact Information:
  Telephone: (650) 430-9125 or (949) 633-3327
  General Information: info@asepticsolutions.com




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Last modified:July 23, 2014