Cleanrooms & Gowning (Live)
Certificate Short Course
Cleanrooms are controlled environments in which airborne and surface-bound particles are limited based on the classification of the space. Maintaining particulate specifications requires specific behaviors and protocols, with the goal of maintaining regulatory compliance and ensuring a quality product.
This hands-on course will cover best practices for working in a cleanroom, including gowning and de-gowning (donning and doffing), proper entrance and exiting, behaviors to minimize turbulence and the generation of particulates, and multiple tips for reducing the likelihood of contamination. Topics discussed include architectural features common to cleanrooms, types and classifications, and an overview of cleaning and environmental monitoring procedures. Regulations from the International Organization for Standardization (ISO) and the United States Federal Standards for the use of cleanrooms will be emphasized, with examples of human health and financial consequences resulting from non-compliance.
• Recall the International Organization for Standardization (ISO), its purpose, and cleanroom classifications
• Understand the purpose and influence of standards and regulations in clean manufacturing
• Diagram and discuss cleanroom design, operations, and costs associated with contamination control
• Demonstrate successful gowning and aseptic processing
- Beginner-level through experienced cleanroom professionals
- Pharmacy personnel
- Service providers for ISO and Good Manufacturing Practices (GMP) cleanrooms
This course will take place at the Biotility Education Center in Alachua, Florida, on the following dates:
Tuesday, March 21 (9am-12pm ET)
Thursday, October 19 (1-4pm ET)