IONSCAN tops HPLC for cleaning validation

Related tags Chromatography High performance liquid chromatography

A new way of ensuring that pharmaceutical production lines are free
of cleaning agents has been developed by Smiths Detection and Dober
Group, reports Phil Taylor.

The two companies have unveiled a method for detecting Dober's Chematic pharmaceutical cleaning agents with Smiths' IONSCAN-LS system. The companies claim the analytical method allows drug manufacturers to ensure their equipment is free from cleaning agent residuals 'to nanogram levels with unprecedented speed and accuracy'.

Traditionally, pharmaceutical manufacturers employ high-performance liquid chromatography (HPLC) for cleaning validation. But 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.

In contrast, the IONSCAN-LS system makes use of ion mobility spectrometry (IMS), a fast, simple analytical method for detecting low levels of organic compounds. The IONSCAN-LS provides reliable test results in 45-90 seconds, according to Smiths.

Cost per sample is low and the equipment requires minimal training to use, the company adds. IMS as a method is already used worldwide in airports, border checkpoints and high profile facilities, to detect illicit drugs and explosives.

Dober's detergents cover the spectrum of acidic, alkaline and neutral-based cleaning agents for a diverse set of pharmaceutical manufacturing applications. The analytical method developed by Smiths 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 at Dober.

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, he added.

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.

Dave Johnson, general manager at Smiths, noted that the IONSCAN-LS can reduce downtime by more than 75 percent over conventional methods.

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