Introduction and Fundamentals of Cleanrooms
Cleanrooms establish controlled conditions for many industrial applications, this presentation will describe how cleanrooms are designed, relative to expectations and how they can be maintained at optimum operating conditions.
Fundamentals of Particle Counting
This presentation introduces the fundamentals of optical particle counters (OPCs). Topics include OPC design and specifications, 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.
Introduction to traditional Microbiology Techniques
This presentation reviews the many different types of traditional microbiology sampling within pharmaceutical cleanrooms and discusses the advantages of each type. It also reviews the differences between passive and active monitoring and how each fits into a monitoring program designed to meet the current requirements of GMP
Applications: Cleanroom Standards ISO 14644, GMP
This course discusses the differences between cleanroom certification and monitoring and what is required to perform a cleanroom certification, including an overview of ISO 14644-1 and 14644-2.
Applications: EU GMP Annex 1
Annex 1 requires designing an effective contamination control strategy (CCS) based on a scientific assessment to understand the process and to apply risk management principles. The latest Annex 1 draft frequently uses the terms “risk” “justify” and “strategy”, underlying the importance of these concepts. For Pharmaceutical Manufacturers, understanding this new approach is critical. The presentation will provide insights and highlighting important considerations when creating a contamination control strategy.
Particle and Microbial Data Interpretation (How to Define Meaningful Alert and Action Limit)
Learn how to understand system reports, interpret data and conduct trend analyses, set alarm limits and improve process control on particle and microbial data.
Solutions: Particle and Microbial Portable Monitoring Best Practices
Many environmental monitoring programmes are based on using portable instrumentation at selected location throughout a facility. This presentation will cover the essential elements of instrument use for both microbial samplers and particle counters used to deliver a portable solution to a monitoring program.
When a facility wide automated solution is required the location of sample points takes on a new emphasis, the continuous requirements within GMP regulations should be risk based, and connect back to a centralized monitoring software. This presentation reviews the key elements of instrument design and deployment and the interconnected infrastructure required for a complete solution. It will also review the data and reports that come from automated systems and how to optimize the output.
Solutions: Alarm Rationale
This presentation will look at how to manage data from multiple sensors and then apply appropriate rules to establish operating levels and limits to the data. Both particle and microbial data and trending will be reviewed.
Solutions: Compressed Gasses
This session covers European and Food and Drug Administration (FDA) good manufacturing practice (GMP) requirements for particle and 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.