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Projects | Biotechnology

Sterile Compounding Optimization Project

Biotechnology Facility Improvements for Vaccine Production 

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.

Project Snapshot

Location

Ontario, Canada

Square Footage of Project

5000 sqft

Project Type

Antiquated Sterile Compound Manufacturing Process Scale up

Expert Spotlight

Rino Parletta

Vice President, Principal

Rino is the Vice President of Cheme Engineering, playing a key role in business strategy, management of operations, delivery of professional services, financial performance and future growth of the firm.
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At Cheme, we bring the resources and expertise of a large firm and the care and attention of a small firm together to serve every client as a dedicated partner.

Mark Hsu

Project Manager, Process Specialist

Mark has nine years of experience working in the food and pharmaceutical industries, including responsibilities within project management, industrial operations, equipment maintenance, process design engineering, and CQV.
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Cheme’s leadership and team members share a growth mindset which fosters a transparent and supportive environment of collaboration, continuous improvement, knowledge sharing, and exploration.

Rino Parletta

Vice President, Principal

Mark Hsu

Project Manager, Process Specialist

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