This will secure a resilient supply of single-use assemblies by including pre-qualified, alternative components in the design stage to avoid regulatory compliance interruptions and long lead times.
Ensuring Supply Chain Resilience with WMArchitect Interchangeable Parts
The new service for bioprocessing eliminates the disruption of reduced component stock and potential production shutdowns, to instead enable a simplified way to substitute in suitable components with shorter lead times.
Flexible Component Options to Avoid Supply Constraints
WMArchitect Interchangeable Parts provides qualified, alternative component options in an assembly which are agreed during the design stage. This avoids supply constraints of a specific component, such as tubing, tri-clamps and other tube fittings.
Expert Support and Validation for Biopharmaceutical Fluid Management
Alongside the full WMArchitect single-use solutions range from WMFTS, Interchangeable Parts is fully supported by experienced specialist scientists and a Validation Testing team. WMFTS uses the BioPhorum best practice equivalency assessment method to eliminate compatibility, performance and safety concerns.
Mitigating Regulatory Risks and Enhancing Process Agility
Interchangeable Parts offers biopharmaceutical companies a flexible solution to the uncertainty of choosing substitute components and the absence of clear guidance in standardised criteria.
Dr. Nicole Hunter, Head of WMArchitect single-use solutions at WMFTS, said: “Based on sound science and detailed process understanding, we work with our customers to assess form, fit and function for alternative components. Interchangeable components are then advised during the early assembly design stage of your assembly specification.
“We proactively monitor the lead times of components to track whether there are gradual or sudden changes. When a component flags, we can pivot quickly to source a pre-agreed alternative with a shorter lead time. Alternative components can be from WMFTS or from a third-party.
“We’ve adopted the BioPhorum best practice equivalency assessment method to address any concerns over compatibility, performance and safety. Full compliance and traceability is maintained, and by swapping in a component that is more easily available we can limit any disruption to your workflow.
“During the COVID-19 pandemic, as an industry we were not sufficiently resilient to the extreme surge in single-use technology demand. In order to future-proof supply, WMArchitect Interchangeable Parts brings a flexibility and versatility to your process to ensure a simplified, efficient change management which gives greater confidence to regulators.”
Features and Benefits of WMArchitect™ Interchangeable Parts for Bioprocessing
• Avoid the disruption of long lead times by ensuring a resilient supply of single-use components and uninterrupted production
• Mitigates regulatory complications associated with interchangeable components
• WMFTS uses the BioPhorum best practice equivalency assessment method to eliminate compatibility, performance and safety concerns
• Process agility while maintaining full traceability and quality assurance
WMArchitect single-use solutions, which was launched last year, is an end-to-end biopharmaceutical fluid management solution from a single supplier. WMArchitect single-use solutions is designed to offer both standard, ready-to-use single-use assemblies as well as customised designs that are fully supported with tailored validation packages.
