Presentation Abstracts
 

2008 PMF Fall Forum

Recent Advances in Environmental Monitoring

Home Page | Register Now | Speakers| Schedule | Talks| Exhibitors

Solutions for Addressing Fungal Contamination in Cleanrooms Carol Bartnett

Pharmaceutical, biotech and medical device cleanrooms commonly face mold challenges.  These mold (such as Aspergillus, Penicillium, Trychophyton, etc) can have many sources such as bags, boxes, markers, intervention equipment and cart wheels (among others).   Some of these cases had significant adverse effects on manufacturing. 
This presentation and group discussion will review the different types of fungi, killing mechanisms of several types of available germicides, selection criteria for disinfectants, test methods, and recommendations for reducing the likelihood of environmental excursions due to molds.

Development of A Paperless Environmental Monitoring System

Michael Cable

This presentation and discussion will review a recently implemented and validated an automated, paperless environmental monitoring system that has tremendously improved performance efficiency, trending capability, and problem identification/resolution.   Issues surrounding paperless systems, environmental monitoring trending, OOT and report generation will be explored. 

ISO 14644 Series:  Recent Revisions and Proposed Directions

Anne Marie Dixon

Federal Standard 209 was officially withdrawn 6 years ago.  The ISO series of standards  have been used worldwide for cleanrooms and associated controlled environments. Some of the 12 standards have been reviewed and revised.  This presentation will update the standards and present an insight into the revision of ISO 14644-1 and where it fits in the overall scheme of facility qualification and cleanroom management.   

The ISO 14644 series is internationally recognized as standards for cleanroom classifications, environmental monitoring, test methods and operations.  The ISO Technical Committee meets in September 2008 in Cork Ireland.  Anne Marie will present updates on this meeting and lead a discussion on the likely impact of these changes on the manufacturing environment.  A summary of the activities of that meeting will be presented.   

Materials of Construction Based on Recovery Data for Cleaning Validation
Richard Forsyth

The material of construction is a factor In the recovery of residue in cleaning validation. An analysis of existing recovery data showed that recovery factors for drug products on various materials of construction may be categorized into several groupings.  This presentation/discussion with present recovery data among 16 manufacturing sites and how this could be leveraged to substantially reduce the number of recovery studies required for cleaning validation. The analysis concluded that stainless steel could serve as a representative material of construction for most materials used in drug product manufacturing.

Developing an Effective Environmental Monitoring Program and Meeting Regulatory Requirements
Aaron Hubbell

What is environmental monitoring? What are the regulatory requirements? How do I develop my program? What if I don’t do aseptic processing – do I still need an EM program? What sorts of tests and equipment should I use? How do I ensure that my program maintains compliance? What can I expect during a regulatory inspection of my environmental monitoring program?   This introductory session will answers all these questions and more as attendees are given an overview of how to develop an effective and compliant environmental monitoring program.

This session will cover the following areas:

• Regulatory expectations for an environmental monitoring program including FDA and EU considerations

• Aseptic vs. non-aseptic programs Risk-based program development: Tests, action levels, sample locations, sampling frequency

• Selecting test equipment

• Qualifying the program

• Easing the transition between qualification and routine monitoring

• Routine program surveillance: Maintaining compliance and robustness

• Recent inspectional trends and hot topics

• References and resources 

This presentation/discussion will provide a framework for professionals needing to develop an effective EM program while balancing risk between two extremes of over-compliance with excessive business costs versus under-compliance with low business costs.

Recent Changes in USP <1116> "Microbiological Control and Monitoring Environments Used for the Manufacture of Healthcare Products"

Scott Sutton

USP has been working to bring chapter <1116> "Microbiological Control and Monitoring Environments Used for the Manufacture of Healthcare Products" in line with FDA's push for science based regulations.  A major issue with all EM programs is confusion over the purpose of the exercise.  The recent proposals have focused on the purpose of the EM program as a means to monitor the state of control of the facility.  In this regard, the inherent variability of the data must be considered in analyzing the data. 

This presentation/discussion will review the status of the USP chapter, proposed changes and the science behind environmental monitoring programs.

Isolation and Characterization of Bacteria Capable of Tolerating the Extreme Conditions of Clean Room Environments

Kasthruri Venkateswaran

"In assessing the bacterial populations present in spacecraft assembly, spacecraft test, and launch preparation facilities, extremophilic bacteria (requiring severe conditions for growth) and extremotolerant bacteria (tolerant to extreme conditions) were isolated. Several cultivation approaches were employed to select for and identify bacteria that not only survive the nutrient-limiting conditions of clean room environments but can also withstand even more inhospitable environmental stresses. Due to their proximity to spacefaring objects, these bacteria pose a considerable risk for forward contamination of extraterrestrial sites. Samples collected from four geographically distinct National Aeronautics and Space Administration clean rooms were challenged with UV-C irradiation, 5% hydrogen peroxide, heat shock, pH extremes (pH 3.0 and 11.0), temperature extremes (4°C to 65°C), and hypersalinity (25% NaCl) prior to and/or during cultivation as a means of selecting for extremotolerant bacteria.   Culture-independent approaches were employed to measure viable microbial (ATP based) and total bacterial (quantitative PCR-based) burdens. Intracellular ATP concentrations suggested a viable microbial presence ranging from below detection limits to 106 cells/m². However, only 0.1 to 55% of these viable cells were able to grow on defined culture medium. Isolated members of the Bacillaceae family were more physiologically diverse than those reported in previous studies, including thermophiles (Geobacillus), obligate anaerobes (Paenibacillus), and halotolerant, alkalophilic species (Oceanobacillus and Exiguobacterium). Nonspore- forming microbes (a- and β-proteobacteria and actinobacteria) exhibiting tolerance to the selected stresses were also encountered. The multiassay cultivation approach employed herein enhances the current understanding of the physiological diversity of bacteria housed in these clean rooms and leads us to ponder the origin and means of translocation of thermophiles, anaerobes, and halotolerant alkalophiles into these environments."   (abstract from La Duc, M., Dekas, A., et al.  2007.  Isolation and Characterization of Bacteria Capable of Tolerating the Extreme Conditions of Clean Room Environments.  Appl Environ Microbiol. 73(8):2600 - 2611)