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.
Fundamentals of Optical Particle Counters
This presentation introduces the fundamentals of optical particle counters (OPCs). Topics include OPC design and specifications, industry nomenclature, laser light and detector basics, instrument types and a discussion on sensor resolution and accuracy. The objective of the presentation is to establish a common background and language that will contribute to a better functional understanding of optical particle counters.
Monitoring Particles in Air
Get an introduction to the types of particle counters used to monitor aerosol particles. A comparison between mobile, fixed and sequential monitoring, along with the advantages and disadvantages of each method, will be covered. Additionally, specialized applications and possible types of devices to monitor those applications will be discussed. Equipment includes particle counters, spectrometers, monitors and sensors.
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.
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.
Microbial Air Sampling Techniques and Regulations
This session covers European and Food and Drug Administration (FDA) good manufacturing practice (GMP) requirements for microbiological contamination in cleanrooms and for process monitoring. Discuss the different techniques and technologies that are applied across regulated industries to monitor for microbial contaminants, with a specific focus on active air sampling devices. Potential sources of contamination and typical organisms seen in the pharmaceutical environment will also be reviewed.
Microbial monitoring & advancements in microbial sampling in a sterile environment
Data interpretation for particle counters and microbial monitors
Understand system reports, interpret data and conduct trend analyses, set alarm limits and improve process control.