For containment performance verification studies
SafeBridge Consultants’ industrial hygiene analytical laboratory in Mountain View, California, US has validated an air sampling and analytical method for measurement of lactose and mannitol on filters. SafeBridge methods will detect 2 nanograms (ng) of lactose or 1ng of mannitol per filter in air samples collected on appropriate media.
Lactose and mannitol are used for containment performance verification studies in the pharmaceutical industry and as a safe surrogate for more toxic compounds to assess potential worker exposure during ‘simulated’ operations. Although using naproxen sodium as a surrogate is preferable for most containment verification studies due to its dustiness and extremely low limit of detection, lactose and mannitol are used when larger volumes of powder are necessary and when quality concerns restrict the introduction of additional active pharmaceutical ingredients.
John Farris, chief executive of Safebridge Consultants, said: ‘By investing in the HPLC technology necessary for analysis of lactose and mannitol, SafeBridge can now provide full analytical services to pharmaceutical companies as well as containment device vendors to verify containment performance.’
The company can provide the technical expertise of experienced industrial hygiene staff and the laboratory analysis for any of the surrogates commonly used. It also provides analysis of many APIs to enable industrial hygiene studies during actual operations.
The American Industrial Hygiene Association has accredited the SafeBridge industrial hygiene laboratory for the analysis of APIs. In addition, the laboratory conducts assessments of cleaning methods used for both occupational and cleaning validation purposes.