SafeBridge Consultants, Inc. Announces Development of Analysis for Lactose and Mannitol for Containment Performance Verification Studies
May 11, 2011
SAFEBRIDGE® CONSULTANTS, INC. (“SafeBridge”), headquartered in Mountain View, California, has announced today that its industrial hygiene (“IH” )analytical laboratory has recently 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 1 ng of mannitol per filter in air samples collected on appropriate media.
Lactose and mannitol are used in the pharmaceutical and allied industries for containment performance verification studies 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 (“APIs”).
President and CEO John Farris commented, “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. SafeBridge can provide the technical expertise of our experienced IH staff and the laboratory analysis for any of the surrogates commonly used. We also provide analysis of many APIs to enable IH studies during actual operations. Our chemists have done excellent, scientifically supportable work to meet our customer needs”.
The SafeBridge industrial hygiene laboratory is accredited by the American Industrial Hygiene Association (“AIHA”) for the analysis of APIs. The SafeBridge advantage is the application of the most sensitive techniques in the industry (including immunoassays) to detect potent drugs at very low concentrations in the workplace. In addition, the laboratory conducts assessments of cleaning methods used for both occupational and cleaning validation purposes.
SAFEBRIDGE CONSULTANTS, INC. is the premier occupational health and safety consulting firm to the pharmaceutical, biotechnology and fine chemical industry with offices in Mountain View, CA, New York, NY and Liverpool, UK. SafeBridge has provided the Potent Compound Safety Triangle® of services in IH, occupational toxicology IH analytical chemistry to over 500 business units worldwide.
For more information, contact:
John P. Farris, CIH
President and Chief Executive Officer
650-961-4820 x 229