Rapid Microbiologic Test for Drug Manufacturers

A new rapid method of detecting microbiologic contamination provides results to drug manufacturers within 24 hours of testing, versus the three to five days of traditional technologies.

Called the Pallchek Luminometer, the new method has been cleared by the U.S. Food and Drug Administration (FDA) as part of the quality control process for a prescription nasal spray product being produced by GlaxoSmithKline (GSK, London, UK). GSK is the first pharmaceutical company to obtain approval to release a prescription product to market using a rapid detection technology under the FDA Process Analytical Technologies (PAT) program. The PAT initiative is designed to encourage manufacturers to adopt new analytical technologies to better control manufacturing processes and provide greater assurance of product safety.

The Pallchek Luminometer identifies the presence or absence of microbiologic contamination in less than 24 hours by assessing the presence of a specific marker of the test organisms. This allows drug manufacturers to take faster corrective action, should contamination be identified. The Pallchek Luminometer is an easy-to-use effective tool for monitoring microbiologic contamination in final products, water for injection, raw materials, and the manufacturing environment.

The Pallchek Luminometer was developed by the Pall Corporation (East Hills, NY, USA). "The FDA approval of Pallchek Luminometer technology as part of the GSK process sends a strong message of confidence in the test's accuracy and sensitivity, and supports more routine and widespread use of rapid microbiology analysis methods,” said Kenneth L. Harris, President of Pall BioSciences.




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