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

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 90-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