Smiths Detection

July 11, 2005
Analytical Method Validates Residue-Free Cleaning

Smiths Detection and Dober Group have released their method for detecting Chematic pharmaceutical cleaning agents with the IONSCAN-LS. The analytical method will ensure pharmaceutical manufacturers that their equipment is free from cleaning agent residuals to nanogram levels with unprecedented speed and accuracy.

Traditionally, pharmaceutical manufacturers employ a method called high-performance liquid chromatography (HPLC) for cleaning validation. Due to the long setup and analysis times, this analytical method often requires one to two days of downtime before processing equipment can be certified for cleanliness.

Ion Mobility Spectrometry (IMS) technology is a fast, simple analytical method for detecting low levels of organic compounds. The IONSCAN-LS provides reliable test results in 45-90 seconds, at low cost per sample, and is versatile, rugged and requires minimal training. IMS, as a method, is seen worldwide in airports, border checkpoints and high profile facilities, to detect illicit drugs and explosives, demonstrating its high-speed, accurate capabilities under some of the most challenging environmental operating conditions.

Dober Group’s detergents cover the spectrum of acidic, alkaline and neutral-based cleaning agents for a diverse set of pharmaceutical manufacturing applications. Dober’s formulated detergents provide manufacturers with effective cleaning while minimizing cleaning time and water usage. The analytical method developed by Smiths Detection focuses on one of the families of surfactants used in Dober’s cleaning agents providing customers with quantitative data about the “last to leave” constituent, thereby demonstrating removal of the cleaning agent.

“Pharmaceutical companies have been cleaning successfully with Dober cleaning agents for years, but have been hampered by traditional, slow detection methods to provide the proof of that cleanliness,” said Dan Dobrez, executive vice president, Dober Group. “We are excited that an analytical method as simple and effective as Smiths Detection’s IMS can be used to detect our detergents. The IONSCAN-LS method for the detection of Chematic detergents will become invaluable to pharmaceutical companies trying to reduce their downtime associated with cleaning and cleaning validation, while safeguarding the quality of the products that they produce.”

"Pharmaceutical manufacturers perform extensive cleaning validation tests on equipment prior to initiating a new batch, so the financial implications are significant for companies that can streamline this process. The IONSCAN-LS can reduce downtime by more than 75 percent over conventional methods," said Dave Johnson, general manager, Smiths Detection Scientific. "We are pleased to be able to provide a state of the art method for Dober detergent detection that will provide pharmaceutical companies with such an important competitive advantage in terms of time and cost savings."

For more information on Dober Group, click here.