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

This comprehensive training program will delve into the intricacies of designing an effective cleanroom facility validation protocol and report. Learn when and how to seamlessly transition into routine environmental monitoring processes while upholding optimal control within your cleanroom environment. This training covers cleanroom regulations, the essentials of a sound design, classification criteria, structured validation approaches, and post-validation routine monitoring.

This training will provide participants an understanding of:

• Regulatory Expertise: Understand the regulatory framework governing cleanroom facilities.
• Design Excellence: Discover the key elements of designing an efficient and contamination-controlled cleanroom.
• Classification Clarity: Gain insights into cleanroom classification and its significance.
• Structured Validation: Learn how to structure a comprehensive cleanroom validation.
• Ongoing Monitoring: Explore strategies for continuous cleanroom monitoring following validation.
• Compliance Mastery: Become proficient in meeting specific USP, EU, and ISO requirements.

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 Session :

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

Who Should Attend:

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

Course Director: KELLY THOMAS

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation. Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.