Selecting Alert/Action Limits for Environmental Monitoring Programs

James D. Wilson

in Sterilization of Medical Devices

The two principal purposes of an environmental monitoring program are to provide an assessment of the general microbiological cleanliness of an operation and to assess the state of environmental systems control being cognizant of the numbers and kinds of microbes present a microbiologist can assist in the design of an effective control system. The microbiologist’s challenge is further exacerbated by the adoption of arbitrary limits that are imposed by some Food and Drug Administration investigators. The chapter provides a reference point for adopting official or corporate alert/action levels by using a sound scientific rationale. One important component of an environmental surveillance system is the establishment of alert and action levels. However, given that an environmental program is comprehensive, it is dangerous to consider alert/action limits for a single component of the system independently of the other parts of the environmental monitoring system.

Environmental Monitoring

Jeanne Moldenhauer

in Handbook of Validation in Pharmaceutical Processes, Fourth Edition

Regardless of the type of pharmaceutical product manufactured, there are regulatory expectations that environmental monitoring be performed. Monitoring of water systems, steam systems, and compressed gases are usually included in the realm of environmental monitoring. Typical environmental monitoring programs are focused on aerobic monitoring, as most manufacturing processes have air in the manufacturing process. The intent of the viable environmental monitoring program is to evaluate the microbiological quality of the controlled and critical areas in a sterile product manufacturing facility. An activity frequently forgotten when establishing an environmental monitoring program is the generation of actual test data to support the media selected for growth and the ideal incubation conditions to ensure the recovery of organisms. Regulatory expectations necessitate having a written document that describes the entire environmental monitoring program. Monitoring of the air in aseptic areas is conducted using at least three different methods: active air sampling, passive air sampling, and nonviable particulate monitoring.

Chromatic Monitoring of Complex Conditions

Edited By Gordon Rees Jones, Anthony G. Deakin, Joseph W. Spencer

in Chromatic Monitoring of Complex Conditions

Explaining the chromatic methodology for the intelligent monitoring of complex systems, Chromatic Monitoring of Complex Conditions demonstrates that chromatic processing is analogous to human vision yet also extends into a wide range of nonoptical domains.

Taking a practical approach that utilizes many examples and graphs, the book presents the origin and methodology of chromaticity, before delving into the various applications of chromatic methods. It first describes characteristics of chromatic systems and chromatic processing algorithms, such as H, S, V transformation and basic x, y, z algorithms. The book then discusses the areas in which chromatic monitoring can be deployed, including electrical plasmas, industrial liquids, broadband interferometry and polarimetry, biological tissues and fluids, the environment, and acoustical and vibration signals.

With contributions from international authorities in the field, this volume shows how chromatic analysis is useful for investigating diverse complex systems and for processing large amounts of information about system behavior, from direct physical parameters to holistic system overviews. By covering the broad capabilities of the methodology, it provides the basis for adapting chromatic techniques in future work.

Quality assurance for environmental monitoring programs

Published in Accountability in Research

John Lawrence 

There are three essential elements of a quality assurance program; a quality assurance management plan, internal quality control measures and external quality assessment including an audit scheme. It is the program managers responsibility to ensure that these activities are clearly defined and documented and that individuals are assigned responsibility for their implementation and are held accountable. A generic quality assurance program is described with an outline of the main component elements.

Comparison of Count Modeling Techniques for Estimating Environmental Monitoring Limits in Clean Rooms

Published in Statistics in Biopharmaceutical Research

Plinio A. De los SantosJi Young Kim

Pharmaceutical and biotechnology industries manufacture their products in clean rooms, which are designed to minimize levels of particulates (like microorganisms recovered from the air or from the clean room surfaces). Alert and action limits are employed to monitor and control the state of the room, keeping the level of particulates at appropriate levels. Particulate monitoring systems could generate particulate count data with the following characteristics: have repeated counts, have inflated zero or low counts, and could be dispersed and have distributions with long thin tails to the right. In this article, we present comparisons of four statistical modeling techniques for setting alert and action limits (i.e., traditional percentile, parametric bootstrap, nonparametric bootstrap, and Bayesian with informative priors) using simulated environmental monitoring data under controlled experimental conditions, to better understand the strengths and limitations of these techniques.

Environmental Monitoring in Urban Areas: Political Contexts and Policy Problems

Published in Journal of Environmental Planning and Management

Gordon W Alker

Environmental monitoring activities are examined from a perspective which focuses on the political, economic and social factors which shape what we know and do not know about local environments. A UK urban case study is used to examine the range of influences that can operate on local level monitoring and comparisons are then made with the situation in three other European cities. Conclusions are drawn which debate the appropriate balance between local discretion and national and international direction in the collection of environmental information. It is argued that scrutiny of and revisions to the quality of current environmental monitoring in the UK and wider debate over questions of purpose, scope and resource commitment are needed.

Environmental Monitoring Systems

Published in IETE Journal of Research

M. V. Bopardikar

The current status of air pollution control in India is discussed. The concern with air pollution in urban areas related to the emission of a variety of gases and particulates is often followed by secondary reactions in the air. Recent evidence has made it clear that all metropolitan areas have limited air resources. Procedures for identification of specific compounds contributing to air pollution are tedious and expensive. Instrumentation plays a very important role in measurements which is the starting point—integrated, automatic, continuous both of the ambient and stacks. Three examples of putting systems approach to work functional diagrams of Dutch National Network—Rijmond Project Fricktal Network of Rotterdam Industrial Area and many more of the research work Triangle of USPHS, have been given.