Fundamentals of Particle Counting
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.
GMP Requirements for Environmental Monitoring (including Annex 1 Update)
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.
Understanding and Applying ISO 14644-1, 2 (Cleanroom Certification, Monitoring, and Validation)
Did you know that the particle counter you use could impact the certification process? 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.
Air, Compressed Gas, and Surface Sampling Techniques (Particle & Microbial)
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.
Moving from Settle Plates to Continuous Active Air Sampling
Historically, cGMP guidelines highlighted their expectations around microbial continuous process monitoring in A and B grades (FDA guideline 2004 and Annex 1 2008) by referring to settle plates, because no other technology was readily available. Regrettably, settle plates are unable to be validated. Here, we will discuss current scientific knowledge around active air/automated vs. passive air/settle plate microbial monitoring as part of a routine environmental monitoring procedure.
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.
Statistical Tools
This Environmental Monitoring Course will show you how to anticipate microbial events due to variable forces in a cleanroom. You will learn statistical tools used to solve contamination issues, to design environmental control processes and to perform system analyses. We will then help you apply these concepts to set microbial alert and alarm levels as well as standards for clean area recovery rates.
Risk Management Methodology
Risk assessment consists of the identification of hazards and the analysis and evaluation of risks associated with exposure to those hazards. Quality risk assessments begin with a well-defined problem description or risk question. When the risk in question is well defined, an appropriate risk management tool and the types of information that will address the risk question will be more readily identifiable. As an aid to clearly defining the risk(s) for risk assessment purposes, three fundamental questions are often helpful:
- What might go wrong?
- What is the likelihood (probability) it will go wrong?
- What are the consequences (severity)?
Data Integrity in Pharma (Standards, Guidelines and Best Practices)
Data Integrity discusses maintaining and assuring the accuracy and consistency of the data over its product life cycle. This presentation will review the draft guidance from the FDA for Data Integrity and Compliance with cGMP, as well as other regulatory agency comments, and how it applies to environmental monitoring systems.
Paper to Paperless (Migrating Process, Trending and Efficiencies)
Today, all regulatory agencies are highly focused on data integrity and discourage methods which manually record data. Modern data management systems provide secure data transfer, automated reporting without data integrity fears, and electronics batch release approval processes. Complying with the new requirements present more challenging requirements. Bringing manufacturing processes and controls to a new level can appear simple in theory but provides many challenges in application.
Data Management Software for Root Cause Analysis
Monitoring particles provides real time actionable data. Usually a level of data analysis is needed to determine what action should be taken. This class reviews multiple data analysis techniques and what can be determined from these methods. Everything from particle counts with time to look for basic trend variations to difference from Poissons distribution to determine if the particle variation is systematic or non-systematic. Each of these techniques should allow you to learn new things from your data and better understand particles in your system.
Pharmaceutical Liquids: USP <788> and <1788>
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.
