Our client in the biotechnology industry required optimization of an antiquated sterile manufacturing process that is critical to vaccine formulation. The system needed to be a compact, fully automated design based on ISA-88 batch control standards and integrated into an existing commercial manufacturing facility.
Cheme conducted an engineering feasibility study including a 360-degree mapping of the facility and all supporting utilities to assess current function and provide optimized solutions. The goal was to support the new compounding process and detailed engineering design for the sterile compounding/filtration system and associated CIP System from initial concept to operational readiness. All improvements were made efficiently while maintaining the commercial manufacturing status of the facility.
Cheme found that the existing process was manual and created a bottleneck in the manufacturing. The process was scaled up and fully automated to reduce both the number of lost batches and the total time for manufacturing. The hybrid design integrated single use technologies with high nickel-based steel alloys. Improvements were made with an eye on minimizing disruption to production by surgically isolating a section of the facility during a two week shutdown. This allowed for construction of the new production suites and mechanical space to be completed within the span of a year. Following construction and installation of the new systems, the area was returned back to production with no impact to production.
Antiquated Sterile Compound Manufacturing Process Scale up