S-10. A Review of Cleanrooms and Controlled Environments

Course Description

Following good contamination control principles is critical to achieving product quality. There are currently over 40,000 standards in the field of contamination control. These standards cover cleanrooms in both the industrial and healthcare marketplace. Understanding of the standards and how they apply to the daily operations of your cleanroom and your process is the focus of this in-house course. Pharmaceutical, Biologics, Medical Devices, and associated industries have related but different requirements depending on the class of cleanroom, product and process risks, countries of export, etc. Gowning will be discussed in detail and gowning demonstrations will be presented for both sterile and non-sterile gowning. Sanitization methods will be demonstrated for wall, floors, doors and work stations.

This in-house course will provide an in-depth review of the practices required to achieve the level of product quality.

Course Instructor
This course is taught by Anne Marie Dixon, Managing Partner of Cleanroom Management Associates, a consulting firm that specializes in competitive benchmarking, training, and auditing of clean and aseptic operations and management.

She has been actively engaged in the field of contamination control for over two decades with extensive experience in the areas of training, technical writing, strategic consulting, facility start-up, construction protocols and process optimization.

Anne Marie was the first woman to be elected President of the IEST and was appointed to the position of FELLOW in 1998. She is the first recipient of the James P. Agalloco Award for Excellence in Training and is an active member of the PDA, IEST, ISPE, ASQ, SSA and AMA. She is also an ISO 9000 trained auditor. She is the head of the U.S. Technical Advisory Group - TC 209 and represents the USA on the ISO Technical Committee 209 on Cleanrooms and Associated Controlled Environments.

Learning Objectives

This course will provide the attendees a practical understanding of cleanrooms and controlled environment operations. The students will become familiar with specific standards and the applications of these documents to their industry. This knowledge of cleanrooms and controlled environments will give the students a better understanding of the sources of contamination and how contamination can be controlled and/or eliminated. This basic knowledge can be applied to resolving CAPA and investigational issues and can assist in the determination of risk.

Course Outline

  • Review of basic contamination control definitions
  • Review of design basics
  • People – a source of contamination
  • Gowning and garment selection criteria
    • Material testing and acceptance
    • Gowning sequence
    • Gowning qualification and certification
  • Cleaning and sanitization
    • Tools and equipment
    • Methods of cleaning and sanitization
    • Frequency determination
    • Disinfectant selection and qualification
  • Admittance of items into the controlled and classified environments
  • Environmental Monitoring
    • Comparison of monitoring regulations – EU and USA
    • Determination of locations for monitoring
    • Investigation of excursions