February 15, 2012
SAFEBRIDGE® CONSULTANTS, INC. (“SafeBridge”), headquartered in Mountain View, California, has announced that Excella GmbH ("Excella") in Feucht, Germany 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”) at their chemical plant located in Feucht. Excella has previously achieved the SafeBridge Potent Compound Safety Certification at their oral solid dosage (“OSD”) form facility and this Certification now extends to specific manufacturing and laboratory support areas involved in the synthesis and manufacture of APIs. Excella becomes the first company worldwide to achieve SafeBridge Certification in both OSD product and API synthesis.
SafeBridge conducted a 60-element review of programs, procedures, containment and control over the production of APIs at the company's site. Based on the quantitative results of the Potent Compound Safety Certification program, SafeBridge certifies that Excella meets current industry standards for the safe handling of potent APIs in the identified areas.
The SafeBridge® Potent Compound Safety Certification program verifies performance with established criteria in management, evaluation, exposure control and communication elements of potent compound production operations. Aspects of the program include on-site assessment of the identified manufacturing and laboratory support areas and review of facility features, equipment, training, toxicology and industrial hygiene.
Since program inception in 1999 eleven organizations have achieved "Potent Compound Safety Certification". The Excella API facility joins nine other facilities actively involved in the SafeBridge Potent Compound Safety Certified program.
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 industrial hygiene, occupational toxicology and industrial hygiene analytical chemistry to over 500 business units worldwide and is a leader in recognizing, evaluating and controlling exposures to potent active pharmaceutical ingredients and products.
If you would like more information please contact:
John P. Farris, CIH
President and Chief Executive Officer
650-961-4820 x 229