The Challenge:
USP General Chapter <797> is undergoing revision and there will be significant changes to the requirements for the preparation of allergenic extracts. These changes will require initial training related to garbing and aseptic technique, as well as media-fill testing, gloved fingertip sampling, and surface sampling of the work area. All these requirements are beyond what is currently required for those preparing allergenic extracts. A small allergist’s office wants to be prepared for when the proposed chapter finally becomes official and is feeling overwhelmed by the nuances of the required microbial testing.
The Solution:
Pure Microbiology assessed the office’s needs and developed an on-site training session to address its questions regarding media, incubation, sample analysis, and partnering with an experienced contract microbiology lab. The training session also included a detailed review of garbing, donning sterile gloves, handling media, and proper gloved fingertip and surface sampling technique. In addition, Pure Microbiology provided guidance during the collection of initial and ongoing gloved fingertip sampling, while office staff members performed the sampling.
The Impact:
The training provided office staff with the confidence to perform the required yearly testing on their own. The allergist’s office was also able to make an informed decision to outsource incubation and analysis of microbial testing, as they only have one individual who prepares extracts, saving them time and money.
The Challenge:
An FDA inspection led to heavy scrutiny of an organization’s sterile compounding operation, including the viable air and surface sampling. The result? The organization was issued an FDA Form 483, specifically indicating that the “aseptic processing areas are deficient regarding the system for monitoring environmental conditions.” The organization was tasked with balancing the CGMP expectations of the FDA with meeting USP 797 and state Board of Pharmacy requirements.
The Solution:
A thorough assessment of the organization’s viable sampling program was conducted. Not only were changes to policies and procedures necessary, but those responsible for the viable sampling program required training in sampling concepts and performing microbial excursion investigations. Multiple onsite visits with both staff and pharmacy leadership were conducted, with a focus on training, document review, and contamination control principles.
The Impact:
Over the last several years, the sterile compounding organization has been visited by the Food and Drug Administration, state Board of Pharmacy, National Association of Boards of Pharmacy, and The Joint Commission. Their viable sampling program and excursion investigations were thoroughly evaluated during each of the visits, but they have had zero findings related to viable sampling. The organization also now has the confidence to explain the rationale for their decisions and the knowledge to defend their viable sampling program.
The Challenge:
A leading service provider to the life sciences industry was uncertain of the best way to meet the dynamic airflow smoke pattern testing needs of their USP General Chapter <797> customers. Customer requests varied, leaving the service provider questioning the best practice methods associated with this test. In addition to resolving the dynamic airflow smoke pattern testing debate, they desired an annual training refresher on sterile compounding for their certification technicians.
The Solution:
Pure Microbiology discussed the training request with the Certification Department Manager to fully understand the training needs, and developed a customized 2-hour, on-site training session. The session consisted of a review of sterile compounding, behavior expectations, garbing requirements, viable sampling review, and dynamic airflow smoke pattern testing. As part of the smoke pattern testing discussion, equipment location, aseptic technique, and compounding workflow were reviewed, evaluated, and debated.
The Impact:
This opportunity for open discussion allowed for the service provider to identify opportunities to improve their testing procedures. In addition, it equipped all attending certification technicians with the knowledge and confidence to describe appropriate dynamic airflow smoke pattern testing to their customers. The refresher training on USP <797> topics emphasized existing company policy and highlighted the importance of chapter compliance to ensure patient safety.
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.
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.