August 9, 2007 — /PRNewswire/ — SAN DIEGO, CA — PacificGMP, a contract manufacturing organization (CMO) specializing in the development and manufacturing of biologics using single-use technology, announced today that it has launched environmental monitoring services to the San Diego-area biopharmaceutical industry. Environmental monitoring involves on-site sampling of air, surfaces, and personnel to measure the control of particles in cleanroom environments and manufacturing operations.
“PacificGMP is committed to serving San Diego-area biopharmaceutical companies with environmental monitoring to fulfill regulatory requirements applicable to cleanroom facilities and standard operating procedures,” says Leigh N. Pierce, president of PacificGMP. “This environmental monitoring service fits well with our primary business of cGMP and non-GMP biologics development and manufacturing services utilizing single-use technology.”
PacificGMP environmental monitoring services include measuring surface and airborne viable particles, total non-viable particles as well as establishing routine on-site sampling and process monitoring during product fill or manufacturing and pre- and post-processing. These services facilitate gowning qualification and cleaning validation for ISO Class 5, 6, 7, 8. In addition, the company can assist clients with establishing standard operating procedures (SOPs) for environmental monitoring programs.
PacificGMP is a contract manufacturing organization (CMO) and leader in the industry in single-use technology for development and manufacturing of biologics. Single-use technology eliminates the risk of cross-contamination, has fewer system requirements, and significantly reduces the time required to initiate production. Benefits to clients include rapid project turnaround and the most cost effective solution in the industry. PacificGMP partners with drug developers by providing a range of cGMP and non-GMP services from early stages of process design, development and scale-up, to preclinical and clinical manufacturing. More information can be found by visiting the company’s web site at http://www.pacificgmp.com/.
Leigh N. Pierce