​Matthew C. Lemieux has over 40 continuous

                              years of field experience as a biological safety

                              cabinet certifier, air and water balancer &

                              cleanroom certifier. 

Mr. Lemieux has a B.S. in mechanical engineering from Northeastern University, a Massachusetts E.I.T. registration, an Associate’s Degree in electronics engineering from ITT Technical Institute, a former Massachusetts HVAC license, Eagleson Institute honor member recognition and has been an ANSI/NSF-49 accredited biological safety cabinet certifier since 1997.  He is a NEBB CPT-CP certified professional as well as a holding CETA accreditations for Sterile Compounding Facilities, ASHRAE-110 Fume Hoods and Cleanroom Certifier.

Mr. Lemieux is the most sought-after controlled environment instructor in the United States and Asia. He is a certified NEBB instructor and is a regular contributor to the CETA Performance Review newsletter and NEBB Professional publications. Mr. Lemieux has written two books on cleanroom testing and certification and critical analysis of cleanroom and balancing reports.  His proprietary and unique instructional approaches, methods and material nearly always guarantee both written and practical accreditation exam success with only the minimum mandated requisite field experience.

Credentials

PharmaCerts, LLC

                              Donald F. Cunha has 35 years in the cleanroom

                              industry as a constructor, designer, and certifier.

                              He has worked in aerospace, microelectronics,

                              pharmaceutical, medical and biotechnology.  Core competencies include testing and certification of cleanrooms, troubleshooting, remediation, hepa filters, pre engineering surveys and cleanroom optimization.

                               Mr. Marquis is a R.Ph. graduated from

                               Northeastern University and has over 16 years

                               of experience in the cleanroom operation and

                               certification industry.   While Manager of Record for Freedom Fertility Pharmacy in Byfield, MA the compounding operations were found to be only 4 of 37 pharmacies fully compliant with state rules. While working as Director of Pharmacy Practice at Express Scripts Mr. Marquis had oversight of numerous sterile compounding facilities nationally.  Mr. Marquis began directing and performing testing services since 2014 for approximately 100 cleanroom clients including several institutional networks.  Mr. Marquis has been presenting Live Continuing Education Courses for Pharmacist for Sterile Compounding for the last five years and is also a Patent Holder for “METHODS AND SYSTEMS FOR PHARMACEUTICAL COMPOUNDING”.

In 2016 Brian Marquis obtained the Registered Cleanroom Certification Professional – Sterile Compounding Facilities (RCCP-SCF) from the Controlled Environment Testing Association’s National Board of Testing (CNBT).  While not required to perform pharmacy cleanroom testing, this certification required 2 years of field experience as well as successful completion of  written and practical examinations encompassing both engineering control certification and viable environmental monitoring of pharmacy environments.  The certification demonstrates knowledge and skills not just of technical testing procedures but of cleanroom operation and current regulations.  There are only 285 individuals with this qualification nationally.

Through experience and study, Mr. Marquis has been providing valuable gap analysis and consulting services for facilities to help guide clients with unique practice requirements through the myriad of proposed and new regulations.  Value is added to projects through early interactions, design review, and assistance or performance of final commission/certification with a keen eye focused on possible regulatory inspection aspects as well as engineering control challenges that are unique to 503(a), 503(b), and cGMP practice settings.