Microbes are Everywhere, But How Are Bugs Monitored in the Pharmacy?

Friday, March 22, 2024

1:00 PM – 4:00 PM East Coast USA Time

Location: Orange County Convention Center, W314B

CE: 3.0

ACPE Number: 0202-0000-24-038-L99-P

Number of Hours: 3

Activity Type: Knowledge

Speaker(s)

Chaitali Patel (she/her/hers)

Director, Sterility Assurance and Microbiology
Cardinal Health
Dublin, Ohio, United States

Handout
Erik Pfarr, NEBB CP, NEBB CT, CETA RP-SCF,NSF49 (he/him/his)

Vice President of Operations
Technical Balance, Inc
Indianapolis, Indiana, United States

Handout
Melissa Foster, PharmD, BCNP (she/her/hers)

Pharmacy Manager
Cardinal Health NPHS
Hixson, Tennessee, United States

Handout

Disclosure(s):

Chaitali Patel: Cardinal Health: Employee (Ongoing)

Erik Pfarr, NEBB CP, NEBB CT, CETA RP-SCF,NSF49: BAMF: Consultant (Ongoing); Cardinal Health: Consultant (Ongoing); Eli Lilly and Company: Consultant (Ongoing); Ionetix Corporation: Consultant (Ongoing); Pharmalogic Holdings Corp: Consultant (Ongoing); SOFIE Biosciences: Consultant (Ongoing); SpectronRx: Consultant (Ongoing)

Melissa Foster, PharmD, BCNP: No financial relationships to disclose

We all know the importance of aseptic techniques, disinfecting, and environment monitoring while working in the pharmacy. But keeping “bugs” out and understanding those reports may be a little more complicated. This session will help attendees recognize the requirements of sampling, plan appropriately when failures occur, and gain confidence in explaining reports to auditors.

Learning Objectives:

Describe requirements for Active sampling (air and surface)
Explain when/where to use Contact plates
Discuss potential causes for contamination
Design CAPAs for failures and explain how to resolve a CAPA
Explain the structure and content of EM reports for audit/inspection