About the President - Fran McAteer

Fran McAteer is an expert consultant in USP pharmaceutical microbiology, sterile products development, aseptic technique cleanroom engineering and disinfection control. His expertise has been utilized by pharmacies, biotech, pharmaceutical, medical device, cosmetic and hospital clients. He can be reached at fran.mcateer@xprtmicro.com

Fran has also provided national leadership in USP <797> Sterile Compounding. He has provided industry guidance for MA Board of Pharmacy, major hospital associations, Group Purchasing Organization (GPO) and large multi-bed hospital pharmacies. Fran has provided remediation services for sterile compounding pharmacies due to regulatory intervention and has successfully provided technical expertise in restoring operational activity. He has instituted complete sterile compounding programs for many IV pharmacies including quality procedures, E/M testing, staff proficiencies, risk assessments, facility design, robotic compounding, cleaning and disinfection program implementation. Fran initiated the first-in-the-nation program for USP <797> compliance assessment of 3rd party 503B High Risk Compounders. He has introduced a compliance program for registered compounders to meet the standards as outlined in the recently passed US legislation, Drug Quality & Security Act. Fran is currently a member of the MA Board of Pharmacy (BOP) Advisory Committee. 

Fran’s consultation services have been used in parenterals, biologics, intravenous and implantable devices. He has set up decontamination programs for bacterial, fungal and viral contamination of aseptic operations for FDA regulated companies. Fran has detected contamination sources and implemented corrective action for the manufacture of recombinant products, cell banked products, antisense technology, imaging products, chemotherapy agents and various medical devices (arthroscopic blades, stents, surgical implants). He has authored numerous articles on environmental monitoring and aseptic technique for many drug and device industry specific magazines. Fran has presented at the Clean Rooms Boston 2006 show on Disinfection of Clean Rooms and at the Institute of Environmental Sciences (IES) national meeting 2008 on USP <797> Sterile Compounding of Parenterals. He has received numerous awards including the Best presentation of 2005 from the Society of Facilities Engineers for Clean Room Validation and the Best Paper of 2006 from the Society of Cosmetic Chemists for Prevention of Microbiological Contamination of Cosmetic Products. Fran has just authored a chapter on Setting Up an Environmental Monitoring Program, a Parenteral Drug Association 2014 Pharmaceutical Environmental Monitoring Volume 7, 2017 Environmental Monitoring: A Comprehensive Handbook Volume 8 and Environmental Monitoring for Sterile Compounding to be used as a teaching text for pharmaceutical microbiology. 

Mr. McAteer is also involved in the International Society of Pharmaceutical Engineering (ISPE) task force for Pharmaceutical Water Sampling. Fran also presented at ESTECH 2015 on Risk Assessment for Aseptic Gowning for Institute of Environmental Sciences

Fran is presently the president and founder of Xprt Micro, a microbiology consulting company. It’s mission is to provide technical microbial expertise to a wide array of markets involved with industries faced with microbiological challenges. This includes:

• Patient Care Activities      • Sterile Products Manufacturer         • Pharmacy Compounding 

• Medical Devices               • Nutritional Additives                        • Food Safety
• Biologics                           • Vaccines                                            • Hospital Networks
• Investment Advisors         • Group Purchasing Organizations      • Laundry Associations
• Personnel Protective         • Engineering Services                        • Facility Management
  Equipment Manufacturers 

• Architectural Design         • Home Health Care                            • Cosmetics 

This wide-ranging group of clients sometimes requires comprehensive microbiological knowledge, expertise and application. This is the goal of Xprt Micro. Our strategies and tactics are customized to the goals of the client and involves baseline assessments, failure risk analysis, strategic development plan and hands-on implementation. It is applicable to product development, contamination control, fiduciary advisement, design consultation, process validations and proof of principle verification. Xprt Micro provides an up-to-date approach on current microbiology based issues critical to our clients immediate needs. These are some examples of our widespread projects:

 • Manufacturing assessments for Coronavirus clearance 
• Assisting in pharmacy regulatory remediation 
• Providing verification audits of 3rd party laboratory/calibration services 
• Establishing HAACP programs for food safety 
• Assessing technical expertise and quality systems for laboratory investment acquisition targets 
• Validating new cleanrooms for pharmacy compounding 

Xprt Micro cover a list of topics to provide clients with technical expertise to insure them with more robust decision-making capabilities. Our consultants have expertise in the following: 

• Infections Disease                          • Pharmacology                                     • USP Microbiology
• Viral Clearance                              • HVAC Engineering                             • Pharmacy Management
• HAACP/Food Safety                     • Sterile Compounding                          • GMP/GLP training/auditing
• Personnel training and Education  • Cleanroom Design/Build                    • Disinfection Efficacy
• Sterilization Validation 

Xprt Micro also has 3rd party relationships with laboratories and calibration services if needed. 

Before Xprt Micro, Fran was President of Microbiology Research Associates (MRA), a consultation and FDA microbiology laboratory. He has been with MRA for the past 15 years full time starting in 2000 and as a consultant since the initiation of the company in 1993. His expertise is in pharmaceutical microbiology specializing in compendial testing (USP 51, 55, 61, 62, 71, 85, 795, 797, 823, 1072, 1111, 1116, 1231), disinfection efficacy studies, microbial integrity studies for container closure, medical device sterilization (gamma, EO and Steam), water system qualification (RODI & WFI), microbial challenge studies and cleaning validation. He initiated <797> compliance programs since 2004 and has audited many national 503B pharmacy manufacturers for major hospital associations. He led the company through significant growth and increased market share eventually attracting an investment banking firm to purchase the company in 2015. Fran is an expert in clean room Environmental Monitoring (E/M) program for viable and non-viable particles. His work has included E/M program development, Performance Qualification (PQ), sampling maps, Failure Mode Effectivity Risk Assessments (FMEA), acceptance criteria, pathogenicity impact reports, trend analysis, training seminars and compliance assessment. 

Fran has also held the following positions: 

• President (2008-2015) (Staffing) E/M Associates, Inc., Nashua, NH Founded company to service microbiological projects for multiple markets. Provided onsite contracted microbiologists for cleanroom sampling to biotech and pharma companies for new facilities approval.

• Senior Director of Operations (1996-2000) (Biologics) Organogenesis, Inc., Canton, MA Responsible for implementing a global manufacturing and distribution for the first approved Tissue Engineered commercial biologic product “Apligraf” a human skin biologic for venous ulcer indications. Successfully supplied commercially produced cell banked biologic product to US and European marketplace. • Director of Operations (1994-1996) (Medical Device) Medica Corp., Bedford MA Responsible for the manufacture and quality control of a medical device product for point of care blood gas and electrolytes levels in patients. 

• Site Director (1992-1994) (Parenterals) CIS-US, Inc., Bedford, MA Responsible for engineering, manufacture and distribution of multiple parenteral imaging agent products. Engineered and designed multiple cleanrooms for sterile vial/syringe fill finish operation. 

• Instructor (1983-1994) (Education) Massachusetts College of Pharmacy, Boston, MA Responsible for teaching Introduction to Biology Course for Pharmacy Technician Program.

Mr. McAteer has also been a member of:

• Parenteral Drug Association (PDA) 
• International Society of Pharmaceuticals Engineers (ISPE) 
• Controlled Environment Testing Association (CETA) 
• American Society for Microbiology (ASM) 
• American Society for Quality (ASQ) 
• American Society of Hospital Pharmacies (ASHP) 
• International Academy of Compounding Pharmacists (IACP) 

His bibliography includes: 

Oct 2004, Bioprocess Engineering, Environmental Monitoring: A Primer. 

April 2006, CleanRooms, Understanding USP <797>.

Jan 2007, CleanRooms, Pharmaceutical Microbiology: Harmonizing of the Microbial Limits Tests for Nonsterile Products. 

Feb 2007, CleanRooms, A Firsthand Look at a Successful 797 Compliance. April 2007, CleanRooms, Establishing a Quality Unit. 

May 2007, New England Regional Society of Quality Assurance, The Ins and Outs of Facility Sanitization in a cGMP Environment. 

March 2008, CleanRooms, Maximizing Outsourcing for Compounding Sterile Preparation. 

April 2008, CleanRooms, Getting the Bugs Out: A Look at Environmental Monitoring Compliance. 

April 2009, PharmaManufacturing, USP Updates <61> and <62> for Microbial Testing of NonSterile Pharmaceuticals. 

May 2009, Pharmacy Purchasing and Products, Develop an Approved Vendor Program for Outsourced IV Medication Compounding. 

Mar 2010, Pharmacy Purchasing and Products, Cleaning the Clean Room. 

Mar 2014, Pharmacy Purchasing and Products, Monitoring and Cleaning in the Cleanroom. 

Oct 2014, Setting Up an Environmental Monitoring Program, PDA Environmental Monitoring Textbook, Chapter 8. Editor Jeanne Moldenhauer. 

Sept 2015, Pharmacy Purchasing and Products, Environmental Monitoring & Control in the Pharmacy. 

Sept 2017, Environmental Monitoring for Sterile Compounding, Environmental Monitoring: A Complete Handbook, Volume 8, Chapter 3. Parenteral Drug Association.