API facilities are critical for the development and production of drug concepts. We understand the underlying technology, industry trends, regulatory environment, and manufacturing processes to enable our technical and operational experts to identify opportunities to streamline production and maximize efficiency. We shape breakthrough strategies that yield cost-effective solutions to achieve your business and project objectives.
Our experts design and build facilities that utilize organic synthesis to manufacture bulk active small molecule products for clinical trials and the launch of new drugs. We have a solid understanding and experience in the design of industry leading multiproduct, multipurpose clinical pilot-scale and full-size manufacturing facilities.
Our specialized scope of services includes:
- Integrating bulk API process and facility issues such as processing flow, material handling, people flow, HVAC design, environmental requirements, clean in place, warehousing, utilities and plant support areas.
- Building flexibility, adaptability, cleanability and containment of potent compounds into the overall design and construction of facilities.
- Obtaining the maximum cost and schedule benefits through the use of a modular design and construction approach within client budget and schedule.
- Full range of facility design that integrates process design, equipment and material charging containment philosophy.
- CGMP and FDA/MCA/EU issues, as well as specialized handling of exhaust air and liquid/solid wastes.
- Specifying and designing bulk API production equipment such as reactors, crystallizers, centrifuges, dryers, solids and liquids charging systems, heat transfer systems, solvent storage and distribution, and both product and solvent recovery systems.
- Extensive knowledge of safety and compliance requirements including process equipment validation, general cleaning validation, 21 CFR Part 11 compliance, environmental permitting, waste treatment and hazardous operations analysis.
Featured API Experts
Gerald Cerulli, PE
Sr. Process Engineer
Robert L. De Sonier Jr., PhD
Director of Process Engineering
Sr. Director Global Strategy & Technology
Sr. Director, Technical
Carmella Tallarida, EIT
Lead Process Engineer
Sr. Director, Validation Services