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.
