Conventional microbial collection and monitoring technologies don’t readily distinguish contamination from microbial contaminants present in a cleanroom air system from that introduced by other sources. This is one reason Pall Life Sciences (East Hills, N.Y.) signed a licensing agreement with Biotrace International Plc. (Bridgend, Wales) for global distribution of its “Ascotec” air monitoring system (see Fig. 1). The agreement also calls for the two companies to work together on the development of additional products for the rapid detection of contamination.
Aimed at the production and regulatory requirements of new biopharmaceutical drug makers, the Ascotec system uses precision 90 mm-wide nozzles to direct the airflow onto less than 0.6 percent of the dish surface which means any random contamination present outside the controlled impact region of the assay can be distinguished from that contributed by the cleanroom air itself. The average concentration of suspended particles present in the air can then be calculated from the number of microorganisms collected and the volume of air sampled.
Says Chris Mach, marketing manager of biotechnology at Pall Life Sciences, “The latest addition to our “Pallchek” Rapid Microbiology Platform, the Ascotec system will greatly help biotechnology and pharmaceutical companies minimize their risk of non-compliance stemming from inaccurate contamination analysis.”
Ascotec is based on Biotrace’s “BioCapt” impactor sampler head technology, which is able to operate at low velocity while maintaining a high collection efficiency. The system uses a vacuum pump to pull air and any associated contamination downward onto an impaction plate without putting unnecessary physical stress on the microorganisms being collected. Because of the low linear velocity (max. 20 m/sec) collection capability, the sampler is able to intercept particles that would normally lack sufficient sedimentation speed to be collected. A gas filter scrubs the collected airstream of any residual contamination before returning it to the external environment. As explained by Mach, since most airborne microorganisms are transported via dust particles, the impactor technology is able to collect the microorganisms on the impactor plate while filtering the particulate via the in-line filter.
The system is available either as a remote or portable sampling system. The remote version (“AirCapt Multipoint MP8+”) has eight sampling lines that can be configured and monitored remotely for simultaneous and/or sequential sampling of up to sixteen independent lines. A centralized vacuum system and micrometric regulation valve ensure consistent and accurate sampling by providing a constant vacuum pressure and flow rate of 25 L/min regardless of the number of lines active.
The portable “MiniCapt PS1” sampler can operate at either 25 or 50 L/min and is monitored in real time (see Fig. 2). The system will automatically alarm if the sampling process is disrupted. Both the remote and portable systems meet European, North American and Japanese Good Manufacturing Practices (GMPs), the most recent ISO standard 14698 and GMP sanitization requirements, and 21CFR Part 11 software compliance requirements.
Mach says he sees a growing awareness and agreement in industry that there needs to be better control and monitoring of manufacturing environments for microbial contamination. “In particular we see people addressing the requirements of ISO 14698 and recognizing the need to be in compliance.”
The portable “MiniCapt PS1” Ascotec sampler can operate at either 25 or 50 L/min.
Pall is currently in communication with the FDA relative to the potential benefits of Ascotec, particularly as it applies to the agency’s Process Analytical Technology (PAT) initiative. A remote system has also been installed at the PDA training facility in Baltimore to provide hands-on exposure as part of the association’s aseptic processing training.