Environmental Monitoring Program for Aseptic Processing

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.

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.

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