There has been an evolution in the technology for cleaning in place of biopharmaceutical equipment, once accomplished by the use of simple nozzles, pump and tank systems. Hyde Engineering + Consulting is a leader in the field of cleaning validation and cleaning technology and is up to date on the regulatory requirements. This is why the largest biopharmaceutical companies consistently use our expertise for their CIP engineering and validation.
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Diosynth Biotechnology
Hyde provided consultation services to Diosynth (formally Covance Biotechnology Services, Inc.) in the design of process CIP and SIP piping systems for a new biopharmaceutical manufacturing facility in Research Triangle Park, N.C. Emphasizing cleanability by CIP means, the work included development of the process and CIP systems' PFDs; configuration of the process flow paths, CIP circuits, and SIP flow paths; and review and consultation in the development of process systems P&IDs. Additionally, we specified and designed spray devices for process vessels and provided extensive CIP circuit commissioning and validation support.
Lonza Biologics
Hyde provided design, start-up, and validation services to Lonza for their multi-product biopharmaceutical manufacturing facility in Portsmouth, N.H. We reviewed process equipment designs for cleanability; designed and specified the CIP systems; provided control system software development consultation; assisted with the design of the clean utility systems; and provided consultation in the design and execution of cleaning validation studies including the development of the Cleaning Validation Master Plan. We also provided engineering review and consultation for the development of equipment and piping system specifications and process, CIP, and SIP piping installation drawings and details.
MedImmune, Inc.
Hyde provided consultation services to MedImmune in the design of a new biopharmaceutical manufacturing facility in Frederick, Md. This work involved design of the process CIP and SIP piping systems with an emphasis on cleanability by CIP means. Hyde also consulted in the development of the process and CIP systems' P&IDs, and reviewed existing process vessel and equipment designs for cleanability and configuration of the process flow paths, CIP circuits, and SIP flow paths. Additionally, we specified and designed spray devices for process vessels and provided extensive CIP circuit commissioning and validation support.
DSM Biologics (Netherlands)
DSM requested Hyde for consultation on an existing CIP system to resolve cleaning compliance, performance, and capacity issues. Our survey consisted of a site visit, interviews with employees, and documentation review. The final survey report, presented on site, offered results and recommendations, including a path forward with technical solutions in the form of basic design, supported with detailed design where necessary.