Partnership offers novel approach to cleaning validation

Lancaster Labs recently formed a strategic partnership with Smiths Detection to provide a unique service in the pharmaceutical cleaning validation market. Smiths Detection is a leading manufacturer of detection equipment, including the IONSCAN LS Ion Mobility Spectrometry (IMS) System, which can be used to verify the efficacy of cleaning protocols for pharmaceutical manufacturing. The partnership will offer full service instrument support, combined with cGMP method development and validation. Smiths Detection chose Lancaster Labs as their partner because of the company’s experience with analytical method development and solid record of regulatory compliance. Sue Ely, senior chemist, verifies the efficacy of pharmaceutical ingredients by IMS. Currently, many cleaning validation protocols require the use of either high performance liquid chromatography (HPLC) or total organic carbon (TOC) analysis to demonstrate that all traces of contamination from previous operations are removed from the equipment. Lancaster Labs has offered analytical services in support of cleaning validation activities for several years and often includes these techniques in the methods they develop. HPLC methods produce accurate, precise results with good specificity and low detection limits. However, HPLC analysis is time consuming, resulting in extended down time for the equipment being cleaned. The TOC test is faster, but not selective for specific compounds. The IMS has distinct advantages over both HPLC and TOC. HPLC run times are substantially longer than IMS analysis times, which are usually less than one minute. The movement of ions through the IMS produces a plasmagram, which is like a unique fingerprint for each substance. This kind of specificity is not available with TOC analysis. The accuracy, precision, linearity and detection limits produced by IMS methods make it an ideal choice for cleaning validation work. “We are delighted to offer this exciting technology for application in the area of cleaning validation,” says Dr. Tim Oostdyk, executive vice president and chief operating officer at Lancaster Labs. “The IMS System provides rapid turnaround time and very high throughput while maintaining the specificity advantages typically achieved by HPLC methods.” After years of successful use in military and security applications, scientists at Smiths Detection have demonstrated that IMS is also suitable for cleaning validation by developing methods for a diverse list of active pharmaceutical ingredients and cleaning agents. Lancaster Labs recently acquired an IMS, and the company chemists trained with the Smiths Detection Application Group on method development. A variety of service levels are offered to clients who wish to have Lancaster Labs develop IMS methods in support of their cleaning validation projects. In addition to optimizing instrument parameters for the compounds of interest, validation studies to determine precision, linearity, and detection limits may be contracted. Other services include preparation and execution of protocols, method transfers and training of on-site staff to perform testing. Lancaster Labs’ cGMP experience and history of regulatory compliance coupled with the instrument expertise of Smiths Detection make it easy for pharmaceutical firms to take advantage of the speed and specificity offered by using IMS for cleaning validation.