Industries: Pharma / Biotech

Cleanroom Fundamentals - Regulation, Science, Design, Practice, Operation & Management

Course Director: Wen Schroeder

Course Fee: $2150.00 Regular Registration / $1950.00 Early Bird (30 Days in Advance)

Course Description - Course runs 9:00 to 5:00 both days (Breakfast & Lunch Included)

This cleanroom fundamentals course provides comprehensive practical information on microbial contaminants and contamination control in modern cleanrooms. Extensive guidance is presented on the daily functions and monitoring necessary to maintain required cGMP microbial and particle cleanliness levels in cleanrooms.

Topics to be discussed in this cleanroom facility training include:

  • Basics of microbial biology and physiology
  • Cleanroom management and cleanroom design requirements
  • Sources of microbial contamination in cleanrooms
  • Non-viable airborne particle standards and monitoring
  • Airborne and surface microbial standards and monitoring
  • Origin and minimization of pyrogen contamination
  • Cleaning technologies and operations
  • Disinfection and sanitization materials and techniques
  • Rapid microbial monitoring methods
  • Training methods for proper contamination control

Emphasis is placed on attendees sharing information on their practical cleanroom knowledge and experiences with the group.

An extensive appendix providing tables, technical discussions, and scientific literature references is included with the course notes and is intended to provide background material for attendees wishing to go deeper into the subject of cleanroom microbiology.

Who Should Attend

This cleanroom facility training course is designed for professionals of the biotechnology, life sciences, medical, pharmaceutical and cosmetic industries who are interested in gaining a basic, practical understanding of cleanroom technologies.  This includes professionals working in:

  • Regulatory Affairs / Regulatory Operations
  • Microbiology
  • QA/QC
  • Manufacturing
  • Maintenance
  • Facility Management
  • Validation

Course Agenda

DAY ONE

Session 1: Global Regulatory Overview

  • Evolution of modern day cleanrooms
  • Relevant regulatory glossary & definitions
  • Major cleanroom functions & classification schemes
  • Regulatory standards/definitions around the world
  • Regulatory requirements: comparison & contrast

Session 2: Cleanroom Fundamentals – Contaminants & Contamination

  • Understanding contaminants & contamination
  • Sources of contamination
  • Root cause investigation & analysis

Sessions 3-4: Cleanroom Fundamentals - Microbiology for Non-microbiologists

  • Introduction to basic cleanroom microbiology
    • Cleanroom microflora & origins
    • Characterization and identification
    • Microbial growth & survival
    • Biofilm
  • Regulatory requirements & guidance
  • Sources of microbial contamination
    • Surface
    • Water
    • Air
    • People
  • Microbial control & management:
    • Identification
    • Detection
    • Sampling
    • Monitoring

DAY TWO

Session 5: Select Topics on Cleaning & Disinfecting

  • Regulatory definitions and requirements
  • When to clean, when to disinfect?
  • Essentials on aseptic processing
  • Let’s talk about water
  • Cleaning validation

Session 6: Cleanroom Design – Points to Consider

  • Functions of cleanrooms
    • Facility layout
    • Windows and doors
    • Pass-throughs
    • Gowning
  • Construction & materials
    • Materials selection
    • Management of air & filtration systems
  • Environmental control:
    • Air flow / pressurization
    • Temperature
    • Humidity
    • Others

Session 7: Cleanroom Operation & Management

  • Essential environmental monitoring
  • Regulatory requirements & guidance
  • Risk analysis
  • Optimized compliance program
  • Investigation & CAPA

Session 8: Workshop – Case Studies & Current Affairs

Learning Objectives

Upon completion of this course, participants will be able to understand and describe the following:

  • Global regulatory requirements and guidelines
  • Sources and management of contamination
  • Essential cleanroom microbiology – for the non-microbiologists
  • Effective environmental monitoring
  • Investigation and CAPA

Testimonials

"This course gave a great introduction to cleanroom microbiology and the considerations needed to effectively control contamination. The instructor is very knowledgeable in the subject matter. Highly recommend to those interested in making sure your company is in compliance with contamination control practices." Ryan G., QC and Regulatory Compliance Mgr, Albaad USA
"Very knowledgeable instructor with lots of applicable experience. The material matched the course description and gave me exactly what I was looking for." Jon T., QA Director, Closure Systems International
"I really enjoyed this course and found the information helpful and applicable to my current engineering job. The level of detail and content was ideal for my level of knowledge." Jeff B., Project Manager, Advanced Operations, Stryker Endoscopy
"A great class! The Course Director is a very knowledgeable teacher with good presentation of the material." Tim J., Facility Manager, Merit Medical Systems
"This course provided information that DIRECTLY impacted & related to my current job position. The Course Director was very knowledgeable and was able to relate the material to day-to-day 'real world' issues." Michelle C., Sr. Aseptic Technician, Eisai
"This class was exactly what I was looking for! I really enjoyed the format with free interaction and Q&A. I received the information I wanted and the class had a good balance of technical knowledge and practical applications." Mark R., Manufacturing Manager, Genzyme
"The Course Director was clearly very knowledgeable in the broad spectrum of topics covered within this course. I was anxious to learn and was not disappointed. I found the concepts are applicable throughout our facility, not only in aseptic filling but also in other controlled assembly areas." Chris K., QA Manager, Cook Urological
"Very informative seminar. Excellent facility used." Pete G., Associate Quality Engineer, Arrow International
"This course was very informative for me. It helped me to understand basic microbiology without having to take a microbiology course." Manager, Quality Assurance, Chiron
"Fantastic training course!. The instructor was very knowledgeable." David L., Manager, Quality Assurance, Johnson & Johnson
"This was one of the most detailed and thorough cleanroom/aseptic processing training courses I have ever attended! The instructor was very knowledgeable in all areas of the subject, and I truly appreciate the instructor's help and attention!" Mike D., QA Manager, Sabin Corp.
"Extremely well presented course in a comprehensive and informative, yet easy-to-understand style. Excellent content and support notes." Martin P., Group Auditor
"This is an excellent training course for anyone who needs a basic introduction to cleanroom monitoring and the issues relevant to maintaining a cleanroom. The instructor was excellent and able to present the information in as easily understandable format." Patricia P., QA Manager, Baylor Research
"The course was well presented. The Course Director is extremely knowledgable." Paul L., Production Tech, SAFC Biosciences
"This course was extremely well-presented and relevant to my needs. The instructor was very knowledgeable and was able to answer questions and situations very well." Sean P., Senior Quality Engineer, SurModics
"Excellent course! Hit all the topics I was concerned with. I will recommend it!" Jim F., Quality System Manager, Cook Vascular

Frequently Asked Questions

Who are "non-microbiologists"?

A non-microbiologist is anyone who has never taken a course in present-day microbiology or who has taken a course in microbiology a long time ago. The level of this course is suitable for anyone who has had a high school education. For participants who have had previous college-level courses in microbiology, the course may be a review with the addition of the results of new research. The course is updated with the results of new research each time it is given.

I have no formal training in science at any level; will I be able to understand the subject matter in this course?

Yes. Microbiology is a very descriptive science and the basic concepts are not difficult to understand. The course starts by establishing a background for understanding the biology of microorganisms and then proceeds to apply this background to the practical problem of keeping cleanrooms and products produced in cleanrooms free of microorganisms.

What microbiology subjects are covered?

After a discussion of the general features of microbials, the course deals with the common contaminants of cleanrooms: bacteria, bacterial spores, bacterial dormant states, biofilms, mycoplasmas and fungi. Principles and methods for estimating bacterial populations in cleanrooms are discussed.

What cleanroom topics are covered?

Major topics that are covered include; airflow in cleanrooms, sources of microbial contamination, non-microbial airborne particle counting, airborne microbial counting, surface cleaning for removal of microbial contamination, determination of surface microbial contamination, and basic validation of microbial removal. There is also a discussion of emerging methods in preventing, removing, and quantitating microbial contamination

How much are cGMP governmental standards and regulations covered?

Current US and EU standards for non-viable particle and microbial airborne and surface contamination are presented. However, this is not a course where detailed cGMP regulations and auditing are presented and discussed in depth.

Will someone from the medical device industry profit from this course?

Yes. While the standards and regulations for allowable amounts of microbial contamination in medical devices are different and more complex than those for parenteral drugs, the problems of keeping environments where medical devices are manufactured free from microbial contamination are very similar and often identical to the same problems in drug production.

Will someone involved in aseptic processing profit from this course?

Yes. Minimizing microbial contamination in aseptic production cleanrooms is especially important.