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ENGINEERING + VALIDATION

BIOPROCESS DESIGN OVERSIGHT

We have 20+ years experience in the design, qualification and operation of biopharmaceutical facilities. We have worked with some of the largest engineering design firms and manufacturing companies in the world. We have experience in both consulting and operations so offer a unique perspective not offered by traditional engineering design firms.

We consider long-term compliance, operation and reliability as critical factors in the design process. We provide expertise in:

  • Operational Efficiency. Reduced cycle time and operational efficiency are critical sustainable operations at a manufacturing facility. We can analyze your existing process and identify processing bottlenecks to be improved. We have done this successfully on client site resulting in a 47% reduction in process cycle time and an 83% reduction in cleaning cycle times. 

  • Facility Design. The design of the facility needs to be specified correctly from an early stage. We focus on the conceptual design phase to ensure compliant material, personnel, product and waste flows, equipment specification, utility design, CIP/SOP philosophies and waste handling.

  • Cleaning and Sterilization. It is vital to correctly specify CIP/SOP philosophies early in the design phase so that it is considered and adopted in the equipment design. This will ensure processes can be turned around quickly for the next batch while also protecting product, patient and company. 

  • Project Management. We can provide project management support for your improvement projects. Ideally we incorporate ourselves with your site based team and implement efficient project management methods. 

  • Client Representation - we often sit in the interface between client sites and engineering design firms to ensure proposed improvements are in line with industry best practices and regulatory compliance requirements

  • Engineering Support - we provide supplementary staff for project deliverables including: URS, FRS, Technical Specifications, Datasheets

  • Design Reviews, including: 30%, 60% and 90% reviews, GMP and HSE and reviews

  • Project Documentation, including: User Requirement Specifications (URS), Technical Specifications, Datasheets, Plans, Protocols and Reports

  • Validation Support, including: Commissioning, Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ) protocol generation and execution

 

We work in collaboration with your onsite team and design partners to support your remediation activities. Quality, compliance and project delivery are at the core of what we do. Get in contact today to see how we can assist with your engineering and validation projects.