Powered by Collaboration, Driven by Quality
Abby contributes deep laboratory and quality leadership experience, including service as quality director at a contract pharmaceutical microbiology laboratory. She holds the Certified Manager of Quality/Organizational Excellence credential through the American Society of Quality. Her background also includes training and curriculum development as a subject matter expert with CriticalPoint LLC, consulting leadership as Director of Microbiology for Clinical IQ, and founding Pure Microbiology in 2022.
Abby’s experience includes long-standing engagement with USP Chapter <797> requirements beginning in 2008 and service as an expert committee member on the USP Compounding Committee from 2015 to 2020. She is also an active leader within the Controlled Environment Testing Association (CETA), serving on its board of directors, speaking at annual meetings and chairing committees that revised four CETA application guides. In addition, she has been invited to speak for state Boards of Pharmacy and national organizations such as National Home Infusion Association (NHIA) and American Society of Health-System Pharmacists (ASHP).
The partnership between Pure Microbiology and Premier brings together trusted expertise in sterile compounding and microbiology with Premier’s broader solutions and services to deliver measurable impact at scale. Combined with Premier’s capabilities, this partnership is positioned to help organizations strengthen compliance, elevate quality systems and adopt best practices more consistently. The partnership is further strengthened by deep, standards-based leadership in sterile compounding and controlled environments, translating Premier’s solutions and services into practical, field-tested guidance for the organizations they support.
Abby Roth has been an invaluable resource for our organization’s sterile compounding program. Abby’s extensive knowledge of USP <797> regulations, best practice compounding skills, and environmental monitoring practices has guided our organization successfully for many years. Abby’s support has been instrumental in helping to develop and implement improved policies to promote rigorous oversight in our sterile compounding program. Abby is extremely efficient with great attention to detail when reviewing certification reports or viable environmental results. I would recommend Abby Roth and Pure Microbiology to anyone in the sterile compounding field who wants a successful and compliant program.
My management staff and I have had the pleasure of working with Abby for ISO17025 audit / accreditation support. Additionally, she has consulted with us on various projects within the Quality and Microbiology world, and has been an excellent outside resource to our organization.
Abby has been my go-to microbial expert. Her knowledge of microbial contamination, EM reports, and sterile facilities, is one of the best in the Industry. She has helped me through the years and I have learned so much about sampling and contamination control from her. Whenever I or a customer have a question, she is always receptive and educational.