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Date: 12th - 13th June, 2008
Location: Malvern, PA , USA
Summary:Pharmaceutical - Training
This course is designed for management and staff involved in cleanroom operations who will benefit from a better understanding of how microbiology impacts cleanroom technology. Although this course will benefit experienced cleanroom personnel, it is primarily designed for those who require a basic understanding of cleanroom operations. The course focuses on cleanroom standards, maintenance and operating procedures.
Learning Objectives
The course will provide a thorough understanding of the operations within a cleanroom environment and the challenges faced by cleanroom staff. In addition, the course will address management of the daily operations of a cleanroom, review of supply and garment usage, the efficiency of cleaning methods and overall cleanroom management.
Course Description
This course provides practical information on contamination control and cleanroom management. Extensive guidance is presented for the critical daily aseptic maintenance and housekeeping functions necessary to maintain the cleanliness levels required.
Topics to be discussed include:
- General product requirements
- Special requirements for sterile products
- Particles, microorganisms and pyrogens
- Review of terminal sterilization process
- Complexity of aseptic processing approaches
- Methods for proper aseptic surface contamination control
- Repair and maintenance technologies & how to start up a new facility