Environmental Monitoring Program for Aseptic Processing

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Environmental Monitoring Program for Aseptic Processing
Level: Intermediate
Lecture Hours: 12.00
Lab Hours: 4.00
Total Contact Hours: 16.00

Description

An Environmental Monitoring (EM) program  provides meaningful information on the quality of  the aseptic processing environment as well as environmental  trends of ancillary clean areas. Environmental monitoring should promptly  identify potential routes of contamination, allowing for implementation of corrections before product  contamination occurs.The establishment of the EM program, training of personnel, data assessment, investigations and product disposition as defined  by regulatory organizations highlight course content.

Topics Include

This two day,16 hour course, covers the following topics:

  • Importance of microbiological evaluation  program for controlled environments
  • Critical  factors involved in design and  implementation of a EM control program
  • Review regulatory requirements for  environmental monitoring programs
  • Establishment of cleanrooms classification and validation requirements
  • Sanitization program for EM
  • Training  and  certification  of
  • personnel (manufacturing and QA/QC)
  • Establishment of sampling plan and sites
  • Establishment of Alert and Action levels
  • Data trending/analysis
  • Methodology for quantitative sampling of airborne and surface microorganisms
  • Methodology and Instrumentation for  quantitative sampling of non-viable total particulates
  • Investigations and assignable causes and  corrective actions

Learning Objectives

Upon successful completion, participants will be able to:

  • Determine the necessary components for an effective environmental monitoring  program for aseptic filling and controlled environments
  • Define regulatory expectations of an EM program
  • Establish and maintain an environmental monitoring program
  • Perform investigations that will withstand regulatory scrutiny ensuring product  quality and patient safety

Audience

Personnel in manufacturing, Quality control, Quality Assurance, Investigations and CAPA resolution and Regulatory Affairs will gain important information in the establishment and implementation of an environmental monitoring program.