Get introduced to cleanroom basics, including a review and comparison of ISO and FS209E classifications. Review particle size, composition, types and sources, and discuss commonly used measurements to define the size of irregularly shaped particles and the implication of each technique. Additionally, you will explore particle concentrations in liquid and air samples.
Understand particle behavior by reviewing transport characteristics, interactions and various forces on particles. Get an introduction to filtration mechanisms and filter efficiency curves for air and liquid systems, and learn about the role played by the refractive index, particle size and shape. In addition, the principles of Rayleigh and Mie light scattering will be covered, including basic scattering relationships.
Environmental Monitoring in Aseptic Pharmaceutical Manufacturing- GMP Requirements
Get an overview of good manufacturing practice (GMP) regulations for environmental monitoring, with a focus on aseptic processing and the differences between cleanroom classification and monitoring. Discussion includes requirements for particle (nonviable) and microbial (viable) monitoring in cleanroom air and compressed gas, with Food and Drug Administration (FDA) and European GMP requirements contrasted throughout the discussion.
Modern Viable Air Monitoring
The value of Knowledge and Know-how in the Pharmaceutical Industry
Understanding ISO 21501-4
The newly released ISO 14644-1:2015 introduces the need for particle counters calibrate to ISO 21501-4. The calibration methods assure data accuracy and repeatability. The methods outlined in ISO 14644 and ISO 21501-4 represent an important step to more accurate evaluations of clean room contamination and improved process control.
Particle Testing in Pharmaceutical Liquids
Take a closer look at the limits and test requirements for pharmaceutical injectable liquids and how those limits were defined. Topics include U.S., European and Japanese Pharmacopoeia requirements, as well as an overview of U.S. Pharmacopoeia guidance and suitable acceptance criteria for equipment used in liquid particle testing.