SafeBridge Consultants, Inc. Announces "Potent Compound Safety Certification" Approval of the SAFC, Saint Louis, Missouri, USA Facility
MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--SAFEBRIDGE CONSULTANTS, INC. ("SafeBridge"), headquartered in Mountain View, California, has announced that SAFC® (www.safcglobal.com), a member of the Sigma-Aldrich® group (NASDAQ: SIAL), headquartered in St. Louis, Missouri, USA has met the criteria established under the SafeBridge program for "Potent Compound Safety Certification" and has been deemed competent and proficient in the safe handling of potent active pharmaceutical ingredients (APIs). The SafeBridge® Potent Compound Safety Certification applies specifically to the site's antibody drug conjugate (ADC) manufacturing and process development facilities and associated quality control laboratories in Building N3 within the St. Louis, MO manufacturing campus.
SafeBridge conducted a 60-element review of programs, procedures, containment and control of the active pharmaceutical ingredients at the company's site. Based on the quantitative results of the Potent Compound Safety Certification program, SafeBridge concluded that SAFC meets current industry standards for the safe handling of potent active pharmaceutical ingredients in the identified areas. Of four new companies seeking SafeBridge certification in 2009, SAFC St. Louis is the first to be certified.
The SafeBridge® Potent Compound Safety Certification program verifies performance with established criteria in management, evaluation, containment, control and communication elements of potent compound production operations. Elements of the program include on-site assessment of the potent compound manufacturing and laboratory areas and equipment, training, toxicology and industrial hygiene.
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 TriangleTM of services in industrial hygiene, occupational toxicology and industrial hygiene analytical chemistry to over 400 business units worldwide and is a leader in recognizing, evaluating and controlling exposures to potent active pharmaceutical ingredients and products.
Sigma-Aldrich® and SAFC® are registered trademarks of Sigma-Aldrich Biotechnology L.P. and Sigma-Aldrich Co.