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 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
