2019 - How to Achieve a Compliant and Effective Cleanroom Design and Facility Validation

Module#1 (Basics Background of a Cleanroom Regulation, Classification and Design)
Summary of the Regulations Guiding Cleanroom Technology, Design and Validation
Types of Cleanroom Classifications and Requirements
EU Vs. ISO Vs. USP Requirements and Classification
Types and Sizes of Cleanroom Particles
Typical Uses of Various Levels of Cleanroom Classifications
How to Ensure an Effective Design of a Cleanroom
Initial Consideration and Roles
What Constitutes an Effective Cleanroom Design
What Materials of Construction to Use in the Design
Specific Design Concept Applicable to Processes
Planning a Cleanroom Design
Who Should be Involved/Roles
Process Steps in the Design of a Cleanroom
Module#2 (Cleanroom Cleaning Validation, Routine Monitoring and Excursion Investigation)
Summary of Cleanroom Validation Process
Process Steps Applicable to Cleanroom Validation
Cleanroom Facility Validation Protocol-Content
Cleanroom Validation Report-Content
Role of Various Departments During the Validation Process
Facility Engineers in the Process
Validation in the Process
Quality Control in the Process
Quality Assurance in the Process
Utilizing Cleanroom Validation Data for Routine Environmental Monitoring Program
Routine Environmental Monitoring Programs Applicable to Cleanroom
Testing Types
Typical Cleanroom Environmental Monitoring Excursions
Investigating and Correcting Cleanroom Environmental Monitoring Excursions
Module#3 (Contamination Control and Disinfection Processes)
Cleanroom Contamination Control and Disinfection Processes
Mitigating Particulate Contaminants
Cleanroom HEPA Filtration
Cleanroom Cleaning, Sanitization and/or Disinfection Process
Other Best Practices - Control of Cleanroom Contaminants:
Cleanroom Personnel Training
Basic Aseptic Practices
Gowning Practices and Personnel Qualification
Personnel Cleanroom Behavior
Question and Answer Session