Pall Introduces Breakthrough Environmental
Air Monitoring Technology to Global Market
East Hills, NY (April 24, 2006) - - The need for faster, more reliable environmental air monitoring is becoming increasingly critical as the number of new drug therapies requiring production in controlled environments continues to rise. Current monitoring technologies do not readily distinguish externally introduced sampling contamination from microbial contaminants captured from the clean room air systems. This can cause delays in microbiological analysis due to "false positives", resulting in loss of both time and money. To resolve this problem, Pall Corporation (NYSE: PLL) is bringing its Ascotec™ environmental air monitoring systems to the global market so that biopharmaceutical companies can increase the predictability and accuracy of microbial samples, for the highest level of speed, safety and reliability.
The Pall Ascotec systems use the innovative BioCapt™ impactor sampler technology to operate at a low velocity, maintaining high collection efficiency while avoiding severe stress to microorganisms. This is achieved by use of laser technology to form precision rectangular slits exactly 90mm wide which create a recognizable pattern of microorganisms on the assay media surface. As a result, random contamination present outside the controlled impact region on that assay plate can be easily distinguished and the actual microbial contamination level in the clean room air accurately determined. The unique BioCapt design separates the Pall Ascotec systems from other sampling systems, which have no mechanism for differentiating between handling and airborne microbes.
The Pall Ascotec air monitoring systems function by pulling contamination downward into the system using a vacuum, where microorganisms are collected onto an impaction plate for observation. An internal gas filter scrubs air before it leaves the system to reduce possible introduction of contamination back into the controlled environment.
"The introduction of the Pall Ascotec systems will have a major impact on the speed and reliability of environmental air monitoring in the U.S. market, which constitutes 40 percent of all clean room space worldwide," says Chris Mach, Marketing Manager Biotechnology at Pall Life Sciences. "Advanced air monitoring technologies help biotechnology and pharmaceutical companies gain better quality control of manufacturing processes and provide greater assurances of product safety. The unique design of the Ascotec systems will help drug manufacturers minimize the risk of non-compliance stemming from inaccurate contamination analysis."
Ascotec Remote and Portable Systems
The Ascotec environmental air monitoring technologies are available as a remote or portable system.
The Pall Ascotec AirCapt Multipoint MP8+™ remote system features eight sampling lines, which can be configured to accommodate simultaneous and/or sequential sampling of up to sixteen independent lines. For maximum flexibility and control, the system allows all sampling parameters to be monitored and set remotely from outside the production area. A centralized vacuum system ensures that the remote system achieves a constant, controlled, defined vacuum pressure, regardless of the number of lines activated. A pre-determined flow rate is set up using a micrometric regulation valve to ensure that every sampling line achieves a constant operating flow of 25 L/min for each sampling unit utilized. This provides the necessary fluid dynamic conditions to guarantee the quality of the acquired data.
The portable MiniCapt PS1™ sampler operates at a constant flow of 25 or 50 L/min, and is monitored in real-time. The system is also designed to automatically send alarm notifications for events that impact the quality of sampling.
Both the remote and portable systems meet all regulatory requirements, including European, North American and Japanese Good Manufacturing Practices (GMPs), CFR21 part 11 for software compliance, the most recent ISO standard 14698, and GMP sanitization requirements.
Rapid Microbiology Technologies
The Pall Ascotec systems exemplify the innovative analytical technologies that the Food and Drug Administration is encouraging pharmaceutical companies to adopt as part of its Process Analytical Technology (PAT) initiative. Under PAT, the goal is to switch from reliance on final product microbiological quality control toward in-process control at key points in the manufacturing process. The ability to monitor quality and identify microbial contamination events during production enables companies to take appropriate actions quickly and avoid unnecessary economic losses.
Pall Corporation will discuss rapid microbiology methods at a presentation at the 2006 PDA Annual Meeting on validating a rapid microbiology system. The presentation will include a case study of a rapid microbiology method using ATP bioluminescence that supports the goals of the PAT initiative.
"As a complementary technology to our Pallchek™ Rapid Microbiology System, the Ascotec air monitoring systems are an important part of the Pall strategy to provide total fluid management solutions across the entire range of biotechnology and pharmaceutical applications," adds Mach.
About Pall Corporation
Pall Corporation is the global leader in the rapidly growing field of filtration, separations and purification. Pall's business is organized around two broad markets: Life Sciences and Industrial. The Company provides leading-edge products to meet the demanding needs of customers in biotechnology, pharmaceutical, transfusion medicine, semiconductor, water purification, aerospace and broad industrial markets. Total revenues for fiscal 2005 were $1.9 billion. The Company headquarters is in East Hills, New York with extensive operations throughout the world. Visit Pall at http://www.pall.com.
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