Single-Use Disposable Technology
The Biotechnology and Pharmaceutical Industries have shown an increasing demand for single-use equipment and components used in a wide array of process and unit operations. While there is no shortage of single-use technology providers, there is a shortage of engineers, specialists and project managers who understand how to effectively implement it and fully understand the impacts associated. Our objective is to provide our clients with turn-key single-use implementation and validation strategies that ensure a smooth transfer from one technology to another. We assist our clients in navigating the evolution of traditional stainless steel assets requiring cleaning and sterilization to the new world of dingle-use disposable technology with new requirements of gamma irradiation and leachable/extractables. We recognize the material management and supply chain impact this technology brings with an increased volume of raw materials and the need for nimple change management.
Our Disposable Single-Use Technology capabilities Include:
- Project Management
- Prototype Development and Testing
- Fit for use Assessment and Evaluation
- Subject Matter Expertise
- Vendor Coordination
- Feasibility Studies
- Comparability Studies
- Engineering Test Plans
- Change Management
- Conceptual and Detail Design
- Commissioning
- Validation
- Procurement
- Material Specifications
- Leachable/Extractables
- Single-Use Technology Transfer
- Process Flow Diagrams (PFD, P&ID)
- Bill of Materials
- User Requirements
- Materials Management and Supply Chain Coordination
- Mixing Studies
- Temperature Mapping
- Destructive Testing
- Process Optimization
- Return on Investment Analysis
- Media Challenge
- Vendor Audit and Inspections
- Vendor Documentation