Conference Description:

This training program will discuss designing an effective cleanroom facility validation protocol and report, when and how to transition into the routine environmental monitoring processes, how to maintain a state of control within the cleanroom, and the routine environmental monitoring and excursion investigation processes.


Why Should You Attend:

This 60-minute training will provide participants an understanding of:

The regulations guiding cleanroom facilities
What constitutes an effective design
Cleanroom classification
How a cleanroom validation should be structured
Routine monitoring of cleanrooms after the facility validation has been completed
Attendees will also gain an understanding of the different classifications and limits specific to the requirements stipulated by the USP, EU and ISO. The ways and types of materials of construction to be used within a cleanroom during the design and construction for an effective design and continuous contamination control will also be discussed.

Learning Objectives:

Discuss the basic background, types of cleanroom classification, various regulations, applications and particulate levels associated with cleanroom facilities.
Discuss the cleanroom design consideration, planning, roles, materials of construction, effective design and execution processes prior to the validation.
Describe cleanroom validation process steps not limited to roles, consideration, planning, execution, protocol and report content and validation process steps.
Discuss the transitional process steps from facility validation into routine cleanroom environmental monitoring processes.
Discuss roles and consideration during these processes as well as how to maintain a state of continuous environmental control and investigations associated with a cleanroom monitoring excursion.


Areas Covered in the Webinar:

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

Who Will Benefit:

Quality Control
Manufacturing/Production
Senior Management
Regulatory Affairs
Quality Assurance
Compliance
Design Engineers
Facility, Maintenance and Engineering
Cleanroom Testing Contractors
Environmental Monitoring Technicians