Book a consulting session with Abby. During our time together, I’ll answer any questions you have related to viable sampling, contamination control, choosing a microbiology lab, or USP <797> compliance. It’s your time to get the answers you need.
30 minutes – $155
60 minutes – $260
A member of our team will email you within 2 business days of your purchase with your virtual meeting link.
I’m looking forward to working with you!
Onsite USP <797> Viable Air and Surface Monitoring Program Evaluation
As part of this service, a consultant will visit your sterile compounding facility, spending one day observing and understanding your workflow. The consultant will evaluate your viable air and surface sampling program, and provide a comprehensive analysis of your SOPs, recent results, and sampling plan, based on USP <797> requirements, contamination risks, and workflow. The report will provide detailed recommendations on sample locations and changes to your overall program. This option provides everything the sterile compounding organization needs to ensure they have a robust viable monitoring program.
Remote USP <797> Viable Air and Surface Monitoring Program Evaluation
The consultant will schedule a call with an individual who best knows the facility’s workflow. The consultant will evaluate your viable air and surface sampling program, and provide a comprehensive analysis of your SOPs, recent results, and sampling plan, based on USP <797> requirements, contaminations risks, and workflow. The report will provide detailed recommendations on sample locations and changes to your overall program. This remote option is an excellent choice for those who have a thorough understanding of their workflow and contamination risks.
Remote USP <797> Sampling Plan Evaluation
This option is for those sterile compounding pharmacies that have a good handle on their overall viable sampling program but want some help in confirming they have the best sampling plan for their facility. Pure Microbiology will schedule a call with an individual who best knows the facility’s workflow. The consultant will then evaluate past data and create a robust sampling plan to ensure the data collected not only meets USP <797> requirements but allows for valuable trending.
Viable Air and Surface Sampling Report Evaluation
Although USP <797> does not have specific requirements for viable air and surface sampling reports, there are minimum elements that must be part of a good report. Most labs cover the essentials, but how can you be sure you are getting everything you need? Our consultant can review lab reports or the data you are collecting internally, if you incubate your own samples, for the essential information required to tell the story of the sampling session. A detailed report will be provided.
USP <797> Exceeded Action Level Support
The consultant will review viable air and surface results and assess appropriate next steps in handling exceeded action levels. In addition to reviewing the report, the consultant may request specific information about past results and facility work practices and, if necessary, have a call with those responsible for organizational compliance. A concise report is prepared with next-step recommendations.
General Microbiology Assistance
Decide on the amount of time you wish to utilize the consultant, and they will be available to assist in your microbiology-related needs.
The consultant will identify what is needed for your organization to implement a USP <797> testing laboratory, including viable and surface analysis, media-fill incubation and analysis, and microbial identification. Additionally, the consultant can assist in the development of a quality program, which incorporates SOPs and necessary training.
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.