2009 Innovation Insight Awards: A revolution in product testing

MOST INNOVATIVE PRODUCT BY A MANUFACTURER ¦ FIRST PLACE Manufacturers of pharmaceuticals, cosmetics, and home care products have made great strides with methods of testing their products for contamination in recent years. With new rapid microbial methods, processes that used to consume 3 to 7 days—waiting to see if there is growth in a Petri dish—can now be completed in 18 hours.



Manufacturers of pharmaceuticals, cosmetics, and home care products have made great strides with methods of testing their products for contamination in recent years. With new rapid microbial methods, processes that used to consume 3 to 7 days—waiting to see if there is growth in a Petri dish—can now be completed in 18 hours.

Since more than 95 percent of products typically test contaminant free, these rapid testing methods have been a financial boon to manufacturers—shortening both the time it takes to get new products to market, and the time it takes to produce batches of existing products.

But in those few instances (less than 5 percent of the time) when a test reveals a potential contaminant, manufacturers must revert to older, slower testing methods to determine if that positive indicator is from a benign source—such as skin flakes from a worker's face—or a potentially harmful organism. If it's the latter, production lines must be shut down for decontamination, at considerable cost to the manufacturer.

That's why a new product from Celsis Rapid Detection has sparked so much interest within the industry. The product—called Celsis ReACT—is a second-stage assay that can determine—within two hours of a positive test result—if the contamination is due to an objectionable organism.

Celsis ReACT was introduced at the Parenteral Drug Association's Microbiology conference February 2009. The product also is the first place winner in the category "Most Innovative Product by a Manufacturer" in MBT's 2009 Innovation Insight Awards competition.

Celsis CEO Jay LeCoque says Celsis ReACT was developed following conversations with long-time customers who had gone to great lengths to wring costs from their supply chains, but still felt burdened by contemporary methods of determining the source of a positive contaminant test result.

"Our customers asked for a way to quickly and easily determine if they have an objectionable organism, so they can minimize the financial impact to their operations and bottom lines," LeCoque says.

The product was three years in development, and in that process Celsis also showed a knack for smart use of information technology.

Microsoft SharePoint Portal was used to create a site to house research results and analysis, as well as work plans, stability testing results, and documentation. When the primary product manager left Celsis, his successor found all the relevant product development history in one place, making for a smooth transition and an easier learning curve. Product validation and testing continued without significant delays.

The initial Celsis ReACT product is used for identifying Gram-negative organisms. This is an extremely important category for manufacturers as it includes organisms that are harmful to humans including E. coli. Most companies classify Gram-negatives as an "objectionable" category of organism.

Following further consultation with customers, Celsis is finalizing a probe set for a Staphylococcus aureus assay (a Gram-positive organism) as well as working on a new kit to detect yeasts and molds.

The company is also talking with customers who are interested in having Celsis develop custom probes for facility-specific organisms or wild strains that can cause significant problems in some production plants.


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