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.

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

Approx Time: 2 days
Level: A
Instructor: Anne Marie Dixon

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