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

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

Charity Ogunsanya
CEO, Laurdan Associates Inc

Charity Ogunsanya, is the CEO and founder of Pharmabiodevice Consulting LLC. Ms. Ogunsanya has over 23 years of extensive practical and management experience in various Fortune 100 pharmaceutical, biotechnology, biologics, cell therapy, diagnostics, research and development, radio-pharmaceutical, Contract Manufacturing Organization (CMO) and medical device/IVD companies.

She has been a much sought after SME to assume key roles specifically related to remediation and difficult quality and compliance related deficiencies associated with FDA’s Consent Decree, FDA’s Warning Letters and other regulatory bodies’ inspectional findings. Her remediation work has constantly resulted in several successful national and international regulatory bodies’ inspections, re-inspections and new product approvals.

Her technical expertise covers and goes beyond interpretation, administration and set up of quality assurance, quality/compliance, quality engineering, aseptic processing, contamination control, quality control, microbiology, sterility assurance, stability, vaccine development, new product design, product release testing and medical device sterilization (ethylene oxide (EtO), gamma, radiation, VHP sterilization) systems and operations for compliance to various regulations.

She has a keen working knowledge of the requirements and regulations guiding new and existing products from planning through design, proof of concept, research and development, technology transfer, pre-clinical, clinical, commercial manufacturing, supply chain, regulatory filings, pre-approval inspections, licensure, government affairs, commercialization and post-approval inspections.

She is a member of the Parenteral Drug Association (PDA), American Society of Microbiologists (ASM), and other Scientific Forums and Industry Expert Network. She has a Bachelor of Science degree in Microbiology from the University of Benin-Nigeria and she is currently attaining her Masters in Biotechnology (Biodefense Concentration) at the Johns Hopkins University Advanced Academic Program.

Topic Background:

An effective cleanroom design helps to facilitate a compliant validation of the cleanroom facility and further continuous state of control of the cleanroom amongst others. The criticality of ensuring a state of control of a cleanroom facility used in a manufacturing process cannot be over emphasized. Ensuring an effective design of cleanroom is the starting point that eliminates future design compliance related issues such as the inability to reduce the cleanroom bioburden levels. A constant high level of facility micro-organisms based on environmental monitoring test results may be impacting to the manufacturing process, loss of the batch of a manufactured product, high cost of environmental investigation, delayed product release, redesign, revalidation, and a host of other issues.

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