Charting and Trending of Environmental Monitoring Data: From Microbial Counts to Contamination Recovery Rates in Controlled Rooms – New Course

The manufacturing of pharmaceuticals, particularly sterile drug products, requires an environmental monitoring program, whereby samples of air (active and passive sampling) and of surfaces (contact plates) are routinely tested for microbiological quality. Thus, a multitude of environmental microbial counts are generated on a routine basis. The pharmaceutical industry then faces the following questions:

• How to organize and present this abundant data in a meaningful way?
• How to set distribution-based and distribution-free control limits?
• How to build informative and useful control charts with this data?
• How to demonstrate that the environmental microbial monitoring process behaves predictably and is under a state of control?
• How to detect a trend in the environmental microbial monitoring process?
• How to demonstrate that the contamination recovery rate meets the new requirements of the recent USP Chapter <1116>?

This basic-level course will first present the methodology of environmental monitoring data analysis by both the statistical distribution-based and the empirical distribution-free approaches. Then, it will teach you the fundamentals of the statistical process control and provide you with practical tools to handle these questions.

After addressing the issue of sample and process variations, hand calculations for building a control chart of microbial counts will be first undertaken in order to better comprehend and assimilate the principles of statistical process control. Then, participants will build control charts of microbial counts which either obey or do not obey Normal or Poisson distributions with a software program (Minitab 17). Case studies of microbial counts generated throughout a year in facilities of sterile product manufacturing will be evaluated in view of detecting a trend, a process average shift and or evaluating the behavior of the environmental microbial monitoring process.

This course will also elaborate on the new paradigm suggested by USP to substitute the regulatory action limits with contamination recovery rates. In the cleanest classified environments (Grades A-B, ISO 5), the contamination is particularly very infrequent and therefore it is treated as a rare event in statistical process control. Instead of near-zero average microbial counts, periodic contamination rates or cumulative recovery rates are monitored and charted. Calculating, tabulating and plotting of these recovery rates as well as excursions rates will be presented in case studies.

Finally, the course will explore how to employ control charting, as well as charts of microbial contamination recovery and excursion rates, as tools for continued verification of the environmental monitoring process behavior and as topics in the annual product review.

Who Should Attend

Microbiologists, production managers, quality control managers, senior management, and personnel in environmental monitoring, quality assurance, regulatory affairs, and those involved in the preparation of the annual product review will benefit from taking this course.

Prerequisites:

Each participant should bring a laptop with Excel and a previously downloaded 30-day free trial of Minitab 17 from http://www.minitab.com. This program should be downloaded a few days before the beginning date of the course and verified that it works on the laptop.