Introduction
The USP released Chapter 797 Sterile Compounding Regulations in January of 2004 with recent updates released December 2008. This Chapter gives the standards of practice for all pharmacies who compound sterile preparations. Many areas are addressed within these regulations including gowning, media-fills, staging, dry-heat sterilization and disinfection of the clean room and materials brought into that area. This CE will provide an understanding of these areas addressed in USP Chapter 797. The importance of microbiology and how it relates to disinfection, staging, sterilization and cleaning will be addressed. At the completion of this program, compounding pharmacists and technicians will have a deeper understanding of several areas addressed within USP Chapter 797.
Learning Objectives
1) Discuss dry-heat sterilization slowest to heat zone validation.
2) Describe the levels of disinfectants and the differences in their ability to kill microorganisms
3) Explain Staging as it applies to microbiology and particulates
4) Demonstrate gowning as it applies to entering a clean room
5) Discuss the appropriate time and size of a media-fill to be performed.
6) Describe the appropriate media, incubation and how often to perform media-fills
Target Audience
Pharmacist
Authors
Megan Jeffrey, MS
Megan Jeffrey, MS, joined PCCA in 2006 as a Pharmacy Compliance Specialist. Her experience includes microbial identifications based on nucleic acid technology to include both Ribotyping and DNA Sequencing. Skilled in both aseptic and environmental microbiology, Megan has experience in pharmaceutical manufacturing, sterilization, pharmacy compounding and rapid microbiological methods. Her formal education includes a bachelor’s of science in biology and chemistry from Barat College, and a master’s in biotechnology and chemical sciences from Roosevelt University.
Keisha Lovoi, RPh
Keisha Lovoi, RPh, joined PCCA in October 2003. Keisha worked several years in chain and independent retail settings before working for several PCCA members in the Houston and surrounding areas. In order to gain further knowledge, she has attended a symposium on Sterile Products: Formulation, Manufacture and Control. Keisha teaches PCCA’s Introductory Aseptic Compounding Course and Advanced Aseptic Compounding Course which focuses on USP Regulations, Aseptic Processing and Quality Assurance. Currently, she is the Chair of the Texas Pharmacy Association Compounding Academy.
Language
English
Accreditation
ACPE UNIVERSAL PROGRAM NUMBER 288-000-07-170-H04-P.
Release Date: 12/20/2007
Expiration Date: 12/20/2010
PCCA is approved by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmaceutical education. This activity will provide a total of 1.50 contact hour(s) (0.1500 CEU'S) of continuing education credit in states that recognize ACPE-approved providers.
