Single-Use Bioprocessing Design, Development and Manufacturing
Bioprocessing technologies continue to evolve to meet the complex and growing demands of biopharmaceutical manufacturing. Today’s facilities increasingly leverage single-use systems (e.g., bioreactors and filtration and chromatography systems) to streamline both upstream and downstream processing. These innovations not only support increased efficiency and scaling of filtration and separation workflows but also enable intensification and reduced water and energy usage.
As biopharmaceutical manufacturing firms continue to develop and implement the next generation of innovative bioprocess solutions, they will require quick and iterative development processes and supply chain resilience. These approaches will be required to enable organizations to produce complex new modalities, quickly, reliably and scalably on a global basis.
Against this dynamic backdrop, a leading player in single-use bioprocessing systems sought a contract development and manufacturing organization (CDMO) with the ability and expertise to provide rapid innovative feedback on manufacturability at scale of plastic single-use molded components. Faced with an urgent timeline and aiming to reinforce their supply chain resilience, the original equipment manufacturer (OEM) engaged Phillips Medisize, requesting design for manufacturability (DfM) and design for assembly (DfA) reports within just 10 weeks.
A precision injection molding redesign challenge to ensure manufacturability at scale
Through extensive computational analysis, and manufacturing expert engagement, Phillips Medisize provided DfM and DfA guidance to address the OEM’s challenges. The OEM’s business growth required its CDMO supplier to offer manufacturing capability at higher volumes and at global sites near the OEM’s regional hubs. The Phillips Medisize team’s timely deliverables and global manufacturing capability helped bolster this leading bioprocessing OEM’s reputation for supply chain agility.
Engineering solutions to support supply chain resilience
Effective supply chain resilience means being ready to adapt when circumstances change—whether that’s due to shifting market demands, supply shortages or new regulatory requirements. Phillips Medisize works closely with customers to ensure their products can be manufactured efficiently and reliably, even when faced with these challenges.
For a more technical view into Phillips Medisize’s engineering approach and design capabilities, click here.
Understanding the Customer’s Problem
The customer, a leading OEM in the life sciences industry, faced several pressing challenges:
- Design Adaptation: They needed to redesign existing components (such as clamps and valve variants) to accommodate new product specifications and tighter regulatory standards
- Manufacturing Consistency: As they prepared for high-volume production using medical-grade plastics, they needed to ensure each part would be consistent in quality and performance
- Regulatory Compliance: Strict standards like ASTM BPE (Bioprocessing Equipment Standard) were required thorough validation, documentation and robust design to guarantee suitability for GMP and regulatory approval
- Process Efficiency: Any delays or defects in manufacturing could lead to costly disruptions in the supply chain
The OEM’s pre-existing designs were not compatible with updated process requirements or regulatory norms. The Phillips Medisize redesign helped this customer avoid production delays, compliance issues and product failures in the field, all of which could have affected their market leadership. The customer needed a way to redesign their products not just to meet new requirements, but to do so quickly, consistently and at scale.
Mold Flow Analysis: What It Is and Why It Matters
A key part of the engineering approach at Phillips Medisize is mold flow analysis: a computer simulation that predicts how molten plastic will flow inside a mold during the manufacturing process. Through this simulation, the team can make sure the molten plastic fills every corner smoothly, without leaving bubbles or weak spots.
- This type of fluid path optimization helps spot potential problems (such as air traps or uneven filling) before any physical parts are made
- By solving these issues early, the team can prevent defects, reduce waste and speed up production
A Seamless Customer Experience
The Phillips Medisize cross-functional engineering team brings together experts in design, manufacturing, materials science and regulatory affairs. With over 60 years of combined experience and more than 200 medical device design and development projects completed in the past five years, Phillips Medisize is well-equipped to manage complex redesigns and ensure a seamless transition from prototype to full-scale manufacturing.
The Phillips Medisize approach includes:
- User Needs Assessment: We start by understanding the customer’s challenges and requirements
- Robust Design and Validation: We generate 3D and 2D designs, run simulations (such as mold flow, structural analysis and fluid dynamics), and validate every aspect of the part to ensure it will work reliably in real-world conditions
- Manufacturing Readiness: By using advanced simulations and early-stage process analysis, we minimize risk and ensure that manufacturing can happen efficiently at scale
- Regulatory Documentation: Comprehensive reports and relevant documentation are provided to streamline regulatory submissions and audits
- Continuous Collaboration: The team works alongside the customer at every stage to adapt to feedback and emerging needs
Phillips Medisize’s experience and multidisciplinary expertise mean we can anticipate issues before they arise, saving our customers time and money while ensuring their products meet the highest standards of safety and quality.
Conclusion
By supporting the OEM in parts redesign and design for excellence engineering for manufacturing at volume, Phillips Medisize enabled the customer to meet its volume and regional demands in a very timely manner.
The Phillips Medisize team has over six decades of experience in design optimization for precision injection molding, scaled manufacturing and automated assembly. Across the US, Europe and Asia, we engage with each customer we are privileged to serve in a tailored, highly personalized way by listening, asking questions and embracing engineering challenges. That’s because we believe the C in CDMO also represents Care — the Care we take in engineering your products and the Care our actions ultimately deliver to patients.
Contact a Phillips Medisize Representative
To learn more about our Life Sciences and Bioprocessing services, fill out the below contact form and a Phillips Medisize representative will reach out to you shortly.