Basic Cleanroom Technology, Operation and Contamination Control in a Nutshell

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)

• Summary of the Regulations Guiding Clean room Technology, Design and Verification
• 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
• Types and Sizes of Clean room Particles
• Typical Uses of Various Levels of Clean room Classifications
• Ensuring an Effective Design of Clean rooms

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

• Clean room Microbes and Microbial Growth:
• Bacteria as a Clean room Contaminant
• Mold as a Clean room Contaminant
• Sources of Clean room Particulate Contaminants
• Sources of clean room particles contamination
• Typical settling rates of particles contaminants within clean rooms
• Contamination Control and Disinfection Processes within Clean rooms
• Mitigating particulate contaminants
• Cleanroom HEPA Filtration
• Cleanroom cleaning, sanitization and/or disinfection process
• Other Best Practices - Control of Clean room Contaminants:
• Cleanroom Personnel Training
• Basic Aseptic Practices
• Gowning Practices and Personnel Qualification
• Personnel Clean room behavior

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

• Cleaning Validation
• Summary of cleanroom qualification processes
• Process steps applicable to clean rooms
• Understanding the importance and utilizing the data from clean room cleaning validation
• Monitoring Cleaning Procedure Effectiveness
• 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.

Charity Ogunsanya
CEO, Pharmabiodevice Consulting LLC

Charity Ogunsanya has over 30 years of extensive experience within the Pharmaceutical, Biotechnology, Biologics, Cell-Therapy, Diagnostics, Research and Development, Radio-pharmaceutical, Contract Manufacturing Organization (CMO) 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 both as a Subject Matter Expert (SME), Site Manager, Multi-site Manager and Director Levels receptively. She has been a sought after expert and have been consistently hired after several competitive efforts by major fortune 100 companies 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 difficult regulatory bodies inspectional findings which is always achieved with a successful outcome. She has also been a sought after expert by various companies requesting her expertise 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 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.

Ms. Ogunsanya is vast in 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. Her expertise has been sought after by several Fortune 100 Pharmaceutical, Biotechnology, Biologics and Medical Device companies as a Quality and Compliance SME during critical national and international regulatory bodies’ routine and new product approval inspections.

She is the CEO of Pharmabiodevice Consulting LLC (www.pharmabiodeviceconsultant.com) targeted towards Quality and Compliance related remediation, enhancements and consultant services for various companies within the industry. She is a well sought after 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.

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