2019 - Basic Clean Room Technology, Operation and Contamination Control in a Nutshell

Module#1 (Basics, Background and Clean room Classification)
Summary of the Regulations Guiding Clean room Technology, Design and Verification
Types of Clean room Classifications and Requirements
EU Requirements and Classification
USP Requirements and Classification
ISO Requirements and Classification
Bridging the Gap between the various Regulatory Bodies’ and Requirements
Types and Sizes of Clean room Particles
Typical Uses of Various Levels of Clean room Classifications
Ensuring an Effective Design of Clean rooms
Module#2 (Basics of Microbiology, Sources of Contaminants and Contamination Control)
Clean room Microbes and Microbial Growth:
Bacteria as a Clean room Contaminant
Mold as a Clean room Contaminant
Sources of Clean room Particulate Contaminants
Sources of clean room particles contamination
Typical settling rates of particles contaminants within clean rooms
Contamination Control and Disinfection Processes within Clean rooms
Mitigating particulate contaminants
Cleanroom HEPA Filtration
Cleanroom cleaning, sanitization and/or disinfection process
Other Best Practices - Control of Clean room Contaminants:
Cleanroom Personnel Training
Basic Aseptic Practices
Gowning Practices and Personnel Qualification
Personnel Clean room behavior
Module#3 (Cleanroom Cleaning Validation, Routine Monitoring and Investigation)
Cleaning Validation
Summary of cleanroom qualification processes
Process steps applicable to clean rooms
Understanding the importance and utilizing the data from clean room cleaning validation
Monitoring Cleaning Procedure Effectiveness
Routine Monitoring Programs Applicable to Cleanroom Particulates
Testing Types
Typical cleanroom deviations and environmental monitoring excursions
Investigating and correcting deviations and environmental monitoring excursions
Question and Answer Session