Basic Clean Room Technology, Operation and Contamination Control in a Nutshell

Charity Ogunsanya

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Attend this webinar to understand the Clean Room regulations, design, classification, sources and types of particles. Learn how to create a common ground between these varying regulations and requirements. It will discuss the types of micro-organisms, routine monitoring processes, and typical mitigation steps to effective contamination control.

Why Should You Attend:

This 90-minute accredited training will offer a basic understanding of the Clean Room regulations, design, classification, sources and types of particles. The different classifications and limits for Clean room particles as it applies to various regulatory bodies’ and requirements (US, EU and ISO) will be addressed. Special attention will be given to understanding how to create a common ground between these varying regulations and requirements will be discussed. The types of micro-organisms, routine monitoring processes, typical mitigation steps in ensuring an effective contamination control through monitoring, sanitization, cleaning, personnel training, gowning, and material, product and personnel flow during a clean room operation will be addressed.

Learning Objectives:

  1. Discuss the basics, background and types of clean room classification.
  2. Described sources of clean room contamination, settling rates and contamination control process.
  3. List the various classifications/levels, regulations, and clean room applications based on classification.
  4. Describe clean room validation process and rationale for performing the validation process.
  5. Discuss the routine clean room monitoring processes and investigations associated with a clean room monitoring excursion.

Areas Covered in the Webinar:

Module#1 (Basics, Background and Clean room Classification)

1.Summary of the Regulations Guiding Clean room Technology, Design and Verification

2.Types of Clean room Classifications and Requirements

  • EU Requirements and Classification
  • USP Requirements and Classification
  • ISO Requirements and Classification
  • Bridging the Gap between the various Regulatory Bodies’ and Requirements

3.Types and Sizes of Clean room Particles

4.Typical Uses of Various Levels of Clean room Classifications

5.Ensuring an Effective Design of Clean rooms

Module#2 (Basics of Microbiology, Sources of Contaminants and Contamination Control)

1.Clean room Microbes and Microbial Growth:

  • Bacteria as a Clean room Contaminant
  • Mold as a Clean room Contaminant

2.Sources of Clean room Particulate Contaminants

  • Sources of clean room particles contamination
  • Typical settling rates of particles contaminants within clean rooms

3.Contamination Control and Disinfection Processes within Clean rooms

  • Mitigating particulate contaminants

4.Cleanroom HEPA Filtration

5.Cleanroom cleaning, sanitization and/or disinfection process

6.Other Best Practices - Control of Clean room Contaminants:

7.Cleanroom Personnel Training

8.Basic Aseptic Practices

9.Gowning Practices and Personnel Qualification

10.Personnel Clean room behavior

Module#3 (Cleanroom Cleaning Validation, Routine Monitoring and Investigation)

1.Cleaning Validation

  • Summary of cleanroom qualification processes

2.Process steps applicable to clean rooms

  • Understanding the importance and utilizing the data from clean room cleaning validation
  • Monitoring Cleaning Procedure Effectiveness

3.Routine Monitoring Programs Applicable to Cleanroom Particulates

  • Testing Types
  • Typical cleanroom deviations and environmental monitoring excursions
  • Investigating and correcting deviations and environmental monitoring excursions

Question and Answer Session

Who Will Benefit:

This webinar will provide a great resource to personnel involved within the following departments in the Pharmaceutical, Biotechnology, Diagnostics, Drugs, Cell Therapy, Biologics and Medical Device industries:

  • Quality Control
  • Manufacturing/Production
  • Senior Management
  • Regulatory Affairs
  • Quality Assurance
  • Compliance
  • Design Engineers
  • Facility, Maintenance and Engineering
  • Test Contractors

However, if you are already familiar with how to achieve an effective Clean room technology and contamination control, you may recommend this webinar to anyone in your company that may require additional knowledge about this subject.

Webinar Events
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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: Charity Ogunsanya, CEO and Founder, Pharmabiodevice Consulting LLC

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.

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