In bioprocessing, manifolds are custom-designed assemblies that connect multiple tubing lines into a single, unified product and using overmoulding reduces risks associated with connectors. Overmoulding is a specialised area of injection moulding.
Together, the result surpasses traditional leak-prone assemblies by providing integrated, sealed units that enhance the reliability and integrity of single-use bioprocess systems. Overmoulding and moulded manifolds provide multiple benefits that include but are not limited to:
Key Benefits
1. Enhanced Sterility and Contamination Control
- Reduces the need for components like barbed fittings and hose clamps.
- Creates a more seamless flow path, reducing dead spaces and potential microbial ingress points.
- Ideal for aseptic operations such as media and buffer preparation, sterile filtration, and final fill.
2. Reduced Assembly Errors
- Moulded configurations minimise time and labor associated with manual fabrication.
- Increases product consistency and manufacturing repeatability.
- Reduces chances of incorrect installation during setup, improving operator safety and process repeatability on the drug manufacturing floor.
3. Accelerated Installation and Turnaround
- Plug-and-play designs simplify equipment setup, enabling rapid changeovers in multi-product facilities.
4. Improved Integrity and Validation
- Overmoulded joints are leak-proof and pressure-tested, reducing the risk of batch loss.
- Smoother inner bores reduce cell shear and entrapment, to improve cell viability.
5. Customised configurations for specific applications based on user requirements such as:
- Upstream: Feed line manifolds for media or buffer delivery and drug substance.
- Downstream: Sample collection or pooling manifolds in filtration or purification steps.
- Final fill: Sterile filling manifolds with multiple filling needles or vessels.
Conclusion
Overmoulding is transforming how bioprocess systems are designed and operated. By utilising high-quality manifolds that are precisely designed and manufactured, they reduce system complexity and enable faster, safer operations.
Manifolds that are overmoulded support the industry shift toward using single-use systems for flexible manufacturing while minimising batch loss and maintaining system integrity.
For companies seeking to scale efficiently while mitigating risk, adopting moulded solutions is no longer just an option but a strategic advantage in the evolving definition of cGMP drug manufacturing.
