Filtration specialists, Pall, and Biotrace have signed an agreement to market microbiological air monitoring technology to the pharmaceutical industry. The deal focuses on microbiological monitoring of manufacturing processes, which is critical to ensuring compliance with regulatory requirements and product safety.
The deal gives Pall exclusive global marketing and distribution rights to the range of Ascotec environmental air monitoring products for the pharmaceutical industry.
They are used wherever clean rooms are required for manufacturing of pharmaceuticals, personal healthcare products and cosmetics and in other clinical environments such as hospitals to reliably capture bacteria in the environment for subsequent monitoring.
The two companies will also work together on the development of additional innovative products for the rapid detection of contamination. Financial terms of the agreement were not disclosed.
The agreement aims to provide access to Ascotec air monitoring technologies to better enable them to achieve the goals of the US FDA Process Analytical Technology (PAT) initiative.
The PAT initiative encourages manufacturers to adopt new analytical technologies to better control manufacturing processes and provide greater assurances of product safety.
"The addition of the Ascotec air sampler to our rapid microbiology platform, including the Pallchek monitor, gives customers access to a technology that meets stringent clean room standards," said Ken Frank, president of
"It is an ideal complement to our capabilities in process and environmental monitoring technology and aligns with our business strategy to be a total solutions provider for the biotech and pharmaceutical industry," he added.
The microbiological control of clean rooms and controlled environments has become a key element of the quality assurance program of pharmaceutical production sites.
Traditionally, these controls are based on the collection of microorganisms onto a media plate followed by incubation over several days.
After the growth period, the contamination level is determined by counting the visible colonies on the plate.
This industrial microbiology market is comprised of six key sectors with some similar testing requirements. Apart from pharmaceuticals, there are the areas of food processing, beverages, personal care products, environmental water and process water.
In 2003, the worldwide market value of industrial microbiology tests was $3.2 billion (€2.6 billion). This is almost double the market value of testing performed in 1993.
By 2008, the industrial microbiology market value is expected to increase by more than 50 per cent, which represents an AARG for market value of 9.0 per cent.
Current microbiological air monitoring technology producers and manufacturers include Sartorius, Labcaire, and France's AES Laboratories.