Michael Connor

Curriculum Vitae

Affiliations

  • The International Society for Pharmaceutical Engineering
  • The International Society for Instrumentation and Control
  • American Society for Heating, Refrigeration and Air-Conditioning Engineers

Wyeth Biologics, Sanford, North Carolina - Development of a plant wide standard for controlled instrumentation to create a “like-for-like” instrumentation substitution list.  The standard allows quick change-out of qualified instrumentation without costly re-validation.

Novoste, Inc. - Retrospective validation of Class 10,000 Clean Room for production of stints used in angioplasty.  Systems validated included air-handling systems HEPA filters, chilled water systems, heating water systems, humidification systems and Siemens Direct Digital Control System for room pressurization control.

Élan Pharma PLC, Athlone, Ireland - Development of a prototypical capsule filling machine for covered retard forms.

Élan Pharma, Inc., Gainesville, GA - 9,500 sqft GMP renovation to support Category 2 controlled substance R&D/Scale-Up for support of Phase-2 and Phase-2I clinical trials.  Project also included the relocation of existing manufacturing operations into new space as well as validation of utility systems.  Validated complex engineered systems including:

  • Glatt GPCG-30 Fluid Bed Dryer – Drying tower, explosion containment systems, Allen Bradley PLC/25 control systems, and WonderWare SCADA system.
  • Glatt GPCG-3 Fluid Bed Dryer – Similar to the GPCG-30 but smaller.
  • 15,000 CFM Desiccant Dehumidification System – Design, program management and validation of the environmental control system. Desiccant dehumidification to 42° F dew point, HEPA filtration to serve class 100,000 clean room.  Clean room tested to class 10,000. Also included validation of Siemens Building Automation system (Landis & Gyr) for room pressure control and communication network.
  • USP Water System – Design, installation and validation of a United States Pharmacopoeia (USP) water generation and loop circulation system.  System qualified for Total Organic Carbon (TOC) content, pH and resistivity.
  • Weighing Booth – Isolates room air from open product containers using a terminal HEPA filtered environment.  Unit was specified to produce class 10,000 conditions and tested at class 1000.
  • CF1000 Granulator – Installed process equipment that granulates the pharmaceutical product for subsequent drying in a cross flow oven.
  • CF360 Granulator – Similar to the CF1000 but smaller.
  • Cross Flow Oven – Existing oven was retrofitted for humidified drying.  It is the only humidified drying oven in the world that works without creating precipitation inside the oven.  The retrofit was designed by Mike Connor’s company.
  • Design and construction of air handling room retrofits for coating of beads.  Project included validation of the air handling systems and room pressure control system.

Serologicals, Inc. - Renovation of 25,000 sf of high bay flex space to production laboratories and manufacturing including validation to FDA/CBER requirements.  The company produces monoclonal antibodies as seed for parenteral products.  Validated systems included class 100,000 cGMP manufacturing clean room with room pressure control, -70c, -45c, and 4c freezers and coolers, as well as CAP Type I Water Systems.

Glaxo Inc. - Produced engineering design documents to install a Bailey Infi90 Distributed Control System (DCS), e.g., Process and Instrumentation Diagrams, Loop Diagrams, Panel interconnection Diagrams, I/O point and Process Database.  System has ~1750 I/O points for over 50 process air handling systems for room pressure control as well as central utilities in pharmaceutical manufacturing plant. Managed production of over 750 drawings including 615 loop diagrams.  Documentation package transitioned into validation of the DCS. Project also involved the changeover from one control system to another. Not one suite was rendered non-useable during the transition.

Publications

Title

Publication

Validation Methods in Pharmaceutical Facilities  Applied to Commissioning of High-Technology Laboratories at Universities

CLIMA 2005, 8th REHVA World Congress Transactions, Lausanne, Switzerland - October 2005

Legal Exposure in Design/Build Contracts

ASHRAE Journal - August 2003

Impact of Change Proposals

ASHRAE Journal - April 2003

User's Guide for Nanotechnology Facilities

R&D Magazine Users Guides - Fall 2003

Case Study - Renovation of a Manufacturing Facility for Production of Clinical Trial Batches

ISPEAK - ISPE Newsletter - January 1999

Use Of Databases To Perform Validation For Pharmaceutical Manufacturing Facilities

Journal of Validation Technology – February 1997

Speaking Engagements

Title

Venue

Date

Can your laboratory realize its full commercial potential? - Navigating the drug approval process

Singapore Biotech Conference

Jan - 09

Case studies in Design/Build Law

ASHRAE Annual Meeting - Long Beach California

Jun-07

Case Studies in HEPA filter challenges for Bio-containment facilities

ASHRAE Winter meeting - Dallas Texas

Feb-07

Differences in BSL-2, BSL-3, BSL-3ag and BSL-4 Labs and Animal Facilities

NC State University

Jan-07

ASHRAE Distinguished Lecturer Series - Bio-Containment

Orlando ASHRAE Chapter Meeting

Dec-06

Differences in BSL-2, BSL-3, BSL-3ag and BSL-4 Labs and Animal Facilities

2nd International Forum on Laboratory Animal Science and Technology, Beijing, China

Oct-06

ASHRAE Distinguished Lecturer Series - Bio-Containment

Ft. Wayne ASHRAE Chapter Meeting

Jul-06

Enduring a Government Tax Audit

ASHRAE Annual meeting - Quebec City, Quebec Canada

Jun-06

Lessons Learned and Best Practices for R&D Facilities

R&D Magazine Lab Design Spring 2006 - Atlanta, GA

Apr-06

ASHRAE Distinguished Lecturer Series - Technical and Legal Aspects of Design Build

Central Illinois ASHRAE Chapter Meeting

Mar-06

ASHRAE Distinguished Lecturer Series - Technical and Legal Aspects of Design Build

Wichita ASHRAE Chapter Meeting

Mar-06

ASHRAE Distinguished Lecturer Series - Technical and Legal Aspects of Design Build

Toledo ASHRAE Chapter Meeting

Feb-06

ASHRAE Distinguished Lecturer Series - Technical and Legal Aspects of Design Build

Memphis ASHRAE Chapter Meeting

Jan-06

ASHRAE Distinguished Lecturer Series - Technical and Legal Aspects of Design Build

Chattanooga ASHRAE Chapter Meeting

Dec-05

ASHRAE Distinguished Lecturer Series - Technical and Legal Aspects of Design Build

Cincinnati ASHRAE Chapter Meeting

Nov-05

Validation Methods in Pharmaceutical Facilities  Applied to Commissioning of High-Technology Laboratories at Universities

CLIMA 2005, 8th REHVA World Congress Symposium, Lausanne, Switzerland

Oct-05

ASHRAE Distinguished Lecturer Series - Technical and Legal Aspects of Design Build

Baltimore ASHRAE Chapter Meeting

May-05

ASHRAE Distinguished Lecturer Series - Technical and Legal Aspects of Design Build

San Diego ASHRAE Chapter Meeting

May-05

ASHRAE Distinguished Lecturer Series - Technical and Legal Aspects of Design Build

Birmingham ASHRAE Chapter Meeting

Apr-05

Bio-containment in an Urban Setting

Tradeline Conference on Bio-containment Facilities - San Francisco, California

Mar-05

ASHRAE Distinguished Lecturer Series - Technical and Legal Aspects of Design Build

Big Sky ASHRAE Chapter Meeting

Mar-05

ASHRAE Distinguished Lecturer Series - Technical and Legal Aspects of Design Build

Gold Coast ASHRAE Chapter Meeting

Feb-05

Nanotechnology Facility Design

R&D Magazine Lab Design Fall 2004 - Boston, MA

Oct-04

ASHRAE Distinguished Lecturer Series - Technical and Legal Aspects of Design Build

Hampton Roads ASHRAE Chapter Meeting

Oct-04

ASHRAE Distinguished Lecturer Series - Technical and Legal Aspects of Design Build

Burlington ASHRAE Chapter Meeting

Sep-04

Differences in BSL-2, BSL-3, ABSL-3 and BSL-3ag Labs and Animal Facilities

Washington State University - Pullman Washington

Jun-04

Marketing Design/Build

ASHRAE Annual meeting - Nashville, Tennessee

Jun-04

Differences in BSL-2, BSL-3, ABSL-3 and BSL-3ag Labs and Animal Facilities

University of California - Riverside, CA

May-04

Differences in BSL-2, BSL-3, ABSL-3 and BSL-3ag Labs and Animal Facilities

R&D Magazine Lab Design Spring 2004 - San Diego, CA

Mar-04

Management Aspects of Commissioning

ASHRAE Winter meeting - Anaheim California

Jan-04

Differences in BSL-2, BSL-3, ABSL-3 and BSL-3ag Labs and Animal Facilities

The Ohio Forum, Ohio State University, Columbus, Ohio

Oct-03

Differences in BSL-2, BSL-3, ABSL-3 and BSL-3ag Labs and Animal Facilities

R&D Magazine Lab Design Fall 2003 - Philadelphia, PA

Sep-03

Humidified Pharmaceutical Cross-flow Tray Drying Ovens

ASHRAE Winter meeting - Chicago, Illinois

Jan-03

Using Spreadsheets to Evaluate Heat Loads in a Brewery

ASHRAE Annual Meeting - Cincinnati, Ohio

Jun-01

From Molecule to Market - GMP Project Delivery

ISPE South Atlantic Chapter Meeting Program - Atlanta , Georgia

Mar-01

Process Air Systems in Breweries

ASHRAE Winter Meeting - Atlanta Georgia

Jan-01

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