a passion for industry; driven to succeed
Abby’s lab experience started in 2004 and continued through 2017, where she held the role of Quality Director at a contract pharmaceutical microbiology laboratory. To improve her quality knowledge base, she holds the Certified Manager of Quality/Organizational Excellence certification through the American Society of Quality. Prior to founding Pure Microbiology in 2022, she was a subject matter expert for CriticalPoint LLC, a health care training and development company. In addition to operational responsibilities, she developed curriculum for educational sterile compounding products. Abby was also a consultant for Clinical IQ, serving as their Director of Microbiology.
Abby’s passion for sterile compounding started in 2008 when USP Chapter <797> introduced the requirement for viable air and surface sampling. This passion really blossomed in 2015 when she had the honor of serving as an expert committee member for the USP Compounding Committee for the 2015 to 2020 cycle. She is an involved member of Controlled Environment Testing Association (CETA), serving on their Board of Directors, speaking at their annual meetings, and chairing committees for the revision of four CETA Application Guides. Abby has been invited to speak for state Boards of Pharmacy and for organizations such as the National Home Infusion Association (NHIA) and the American Society of Health-System Pharmacists (ASHP).
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 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.
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.