BOULDER, Colo. -- (BUSINESS WIRE) -- CordenPharma Colorado (CPC), an Active Pharmaceutical Ingredient (API) manufacturing facility in Boulder, Colorado, announces receipt of approval for the "Potent Compound Safety Certification" by SafeBridge® Consultants, Inc. (SafeBridge), headquartered in Mountain View, California. By meeting the criteria established under the SafeBridge program, CordenPharma Colorado is deemed competent and proficient in the safe handling of potent APIs and compounds of unknown toxicity and potency. The SafeBridge Potent Compound Safety Certification of CordenPharma Colorado applies to specific laboratory and manufacturing areas involved in the manufacture of APIs and synthetic intermediates.
CordenPharma Colorado maintains a robust program for safely handling highly potent APIs and has consistently demonstrated the ability to effectively contain this category of products. CPC’s core competency was developed through a wide variety of physical engineering controls - designed by experienced engineers - combined with an Industrial Hygiene program which demonstrates the effectiveness of those controls. In addition, reliable operators have been trained to make sure proper utilization and maintenance procedures are followed.
As part of the approval process, SafeBridge conducted a 60-element review of health and safety programs, procedures, exposure controls, and process containment of synthetic chemistry operations with occupationally potent active pharmaceutical ingredients at the company's site. The SafeBridge Potent Compound Safety Certification program evaluates performance with established criteria in management, compound evaluation, exposure control, and communication elements of pharmaceutical production operations. Elements of the program include on-site assessment of the potent compound manufacturing and laboratory areas and equipment, training, toxicology as well as industrial hygiene.
The CordenPharma Colorado API facility is now one of only ten companies, and twelve facilities worldwide, which are currently certified in the SafeBridge Potent Compound Safety program.
CordenPharma, a pharmaceutical brand of International Chemical Investors Group (ICIG), is a full-service Contract Manufacturing Organization (CMO) partner in the cGMP Contract Development & Manufacturing of APIs, Drug Products and associated Packaging Services for antibiotic / oncological, peptide / injectable and highly potent / small molecule technology platforms. www.cordenpharma.com.
CordenPharma Colorado, one of multiple CordenPharma facilities across Europe and the US, specializes in the development and manufacturing of advanced intermediates and chemically synthesized APIs with a focus on small to large-scale synthetic peptides, highly potent Cytotoxic and non-Cytotoxic APIs and high volume small molecule APIs. http://cordenpharma.com/facilities/colorado/.
SafeBridge Consultants, Inc., a subsidiary of Trinity Consultants, Inc., is the premier occupational health and safety consulting firm to the pharmaceutical, biotechnology and fine chemical industries 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 700 business units worldwide and is a leader in recognizing, evaluating and controlling exposures to potent APIs and products.