Cleanroom Operations for USP 797

The USP chapter 797 addresses Pharmaceutical Compounding – Sterile Preparations. One of the objectives of this chapter is to describe the conditions and practices that prevent harm to patients that could result from microbial contamination. This course will address cleanroom operations and what is required to reduce the risk of microbial contamination.

Course outline     Who should attend?     Course materials     Instructor    

 


Course outline

 

 

  • Overview of design
  • Personnel – gowning and controls
  • Cleaning and sanitization
  • Admittance and transfer of items
  • Environmental monitoring
  • Operations in a biosafety cabinet or laminar airflow device

Who should attend?

I need to learn about cleanroom operations for USP 797 because:

 

 

  • I design USP 797 facilities
  • I manage and/or operate a USP 797 facility


Course materials

 

 

  • Copy of IEST-RP-CC018.4: Cleanroom Housekeeping: Operating and Monitoring Procedures
  • Copy of IEST-RP-CC026: Cleanroom Operations
  • Copy of PowerPoint presentation in course binder
  • Certificate of attendance for completion of CEUs

IEST-RP-CC018.4 provides guidance for maintaining a cleanroom at the level for which it was designed. This document is intended as a guide for establishing appropriate housekeeping procedures essential for the overall contamination control program of the cleanroom. In addition, test procedures are provided for use in establishing the frequency of housekeeping and monitoring the effectiveness of the housekeeping.

IEST-RP-CC026.2 provides guidance for maintaining the integrity of the cleanroom during ancillary operations.

Continuing Education Units: .6 CEUs

Instructor

 

Anne Marie Dixon