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

Instructor: Charity Ogunsanya
Product ID: 703875
  • Duration: 60 Min

recorded version

1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section

Training CD

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Read Frequently Asked Questions

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

Instructor Profile:

Charity Ogunsanya has over 23 years of extensive experience within the pharmaceutical, biotechnology, biologics, cell-therapy, diagnostics, research and development, radio-pharmaceutical, contract manufacturing organizations (CMOs) and medical device companies.

Throughout her corporate career within these diverse industries, she held various high visibility and business critical roles within the quality and compliance division in major Fortune 100 companies as a subject matter expert (SME), site manager, multi-site manager and as a director.

She has been a sought after expert to assume key roles specifically related to remediation and deficiencies associated with FDA’s Consent Decree, FDA’s Warning Letters and difficult regulatory bodies inspectional findings. She has also been a sought after as a known industry expert to specifically assume roles in order to perform a total overhaul, restructure, compliance remediation, re-organization, start-up processes related to quality systems improvements and/or enhancements. In all cases, her remediation work resulted in several successful national and international regulatory bodies’ inspections, re-inspection and new product approvals.

Her technical expertise are not limited to the interpretation, administration and set up of 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.

She is currently the CEO of Pharmabiodevice Consulting LLC targeted towards quality and compliance related remediation, enhancements and consultant services for various companies within the industry. She is a high level consultant for several international professional expert networks such as Gerson Lehrman Group, Zintro Expert Network and Intota Expert Network. 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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