Excella achieves SafeBridge Potent Compound Safety Certification

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") and potent drug products. The SafeBridge Potent Compound Safety Certification of Excella applies only to specific laboratory and manufacturing areas involved in the manufacture of oral solid dosage ("OSD") forms. Excella becomes the first company worldwide to achieve SafeBridge Potent Compound Safety Certification for the manufacture of OSD forms.

SafeBridge conducted a 60-element review of health and safety programs, procedures, containment and exposure control of OSD operations with occupationally potent active pharmaceutical ingredients 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 evaluates performance with established criteria in management, compound evaluation, exposure 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.

Since program inception in 1999 eleven organizations have achieved "Potent Compound Safety Certification". The Excella OSD facility joins eight other facilities actively involved in the SafeBridge Certification program.

Source SAFEBRIDGE CONSULTANTS, INC.