The Center for Professional Innovation & Education (CfPIE), Malvern, PA
Feb. 26 & 27, 2007
Who Should AttendThis 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 through 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. ________________________________________ COURSE AGENDA DAY ONE Basic Microbiology • How bacteria and viruses live, reproduce, and die • The important physical properties of microbials • How microbials are transported in the environment Controlling the Working Environment: Cleanroom and Processing Fundamentals • What does “aseptic” mean and how can it be attained? • People in an aseptic area • Aseptic techniques • The behavior of environmental particles, microorganisms and pyrogens • General product requirements • Special requirements for sterile products • Review of final sterilization processes • Complexity of aseptic processing approaches Practical Introduction to Cleanrooms • Achieving an aseptic environment - Implications with FDA and current good management practice (CGMP) - Importance of employee hygiene and aseptic gowning - Air filtering • General requirements • Requirements for critical areas and controlled areas • Uses for Controlled Area and Critical Area - HEPA function - The importance of aerodynamics - Air quality - Process gases qualities - Pressure differentials Cleanroom Technology • Selection of construction materials and clean room filtration equipment • Selection and use of process equipment within cleanrooms (autoclaves, tunnels, conveyors, filling machines, etc.) • Air showers, weighing cabinets, material pass-through Cleanroom Technology Standards • Applicable regulations and guidelines • Design criteria/maintenance programs • Environmental control/cleaning and sanitization programs • General aspects of process analysis • Cause and effect relationships • Sterility of components • Primary containers • Sterility of the product DAY TWO Process Simulation/Validation Tests • The human factor • Training, evaluation, and certification programs • Documentation aspects • Access control, common sense, and good housekeeping Cleanroom Optimization and Validation • Cleanroom optimization and validation • Filter integrity, air velocity, air flow patterns, particulate counting, room classification, decontamination times, contamination curves • Cleaning and sanitation methodology, cleaning and sanitation validation Cleanroom Monitoring • Why monitor cleanrooms? • How to establish the normal clean room status, alert and alarm levels • Monitoring equipment; automated environmental conditions monitoring • Microbial monitoring
|