Choosing the right manufacturing approach for an in vitro diagnostic (IVD) consumable starts with the part’s function. Cuvettes, cartridges and sample handling plastics all need to perform reliably within a diagnostic system, but the critical requirements can vary significantly from one component to another. IVD consumables manufacturing brings those functional requirements together with material selection, component design, tooling, quality controls and production scale.
IVD consumables are disposable or application-specific in vitro diagnostic components used to contain, move, process or analyse samples and reagents. Precision injection moulding is often well suited to these parts because it can reproduce complex plastic geometries consistently at production scale. For optical cuvettes, that may mean controlling optical surfaces and path geometry. For diagnostic cartridges, it may mean replicating channels, chambers, sealing areas and mating features. In each case, the manufacturing process must support the requirements that matter most to the finished component.
What Makes IVD Consumables Different From Standard Injection-Moulded Parts?
IVD injection moulding differs from conventional plastic injection moulding because the component may have critical-to-quality requirements that directly affect how it performs within a diagnostic system. A small variation in geometry, surface condition or material behaviour may influence optical performance, fluid movement, sealing, fit or automated handling.
The priorities also depend on the application. An optical cuvette may depend on consistent path geometry and surface quality, while a diagnostic cartridge may place more emphasis on fluidic features, sealing areas and assembly interfaces. Typical considerations can include:
- Tight dimensional tolerances.
- Optical surfaces or fine fluidic features.
- Material and reagent compatibility.
- Appropriate cleanliness or controlled manufacturing.
- Part-to-part and lot-to-lot consistency.
- Compatibility with automated diagnostic equipment.
- Inspection requirements.
- Part and lot traceability.
Not every IVD consumable requires every control. The right manufacturing approach starts with identifying which characteristics are critical to the component’s function, then aligning design, tooling, process controls and quality requirements around them.
IVD Consumables Commonly Manufactured by Injection Moulding
The table below highlights how manufacturing priorities differ by IVD consumable and where injection moulding can support repeatable production.
| IVD consumable | Typical role | Key manufacturing priorities | What injection moulding can support |
| Optical and reaction cuvettes | Hold samples or reaction mixtures for optical analysis. | Optical properties and surface quality; consistent optical path geometry; dimensional and wall consistency; material selection for the analytical method; accurate positioning within diagnostic equipment. | Repeatable optical geometry and dimensional consistency across scalable production volumes. |
| Diagnostic and assay cartridges | Contain, transport or process samples and reagents. | Fluid pathways, chambers and fine features; sealing and mating surfaces; material compatibility; ports and interfaces; joining or welding; assembly and inspection requirements. | Complex functional geometry that can be reproduced consistently as programmes move from development to production scale. |
| Sample-handling plastics | Hold, transfer, position or process samples, reagents and reaction materials. Examples may include cups, containers, tips, plates and racks. | Dimensional accuracy and stability; chemical compatibility; containment; fit and positioning; cleanliness where required; compatibility with automated diagnostic equipment. | High-volume disposable components that require consistent fit, handling and interaction with diagnostic or laboratory equipment. |
These priorities vary by application. A cuvette may place greater emphasis on optical properties and geometry, while a cartridge may depend on fluid pathways, sealing and assembly. Sample handling plastics often require consistent fit and interaction with automated equipment.
Designing IVD Components for Injection Moulding
Consider material choice and component design together. An IVD component must meet its functional requirements while also being suitable for repeatable moulding, assembly and inspection at the intended production scale.
Material Selection
There’s no single best plastic for every IVD consumable. Resin selection starts with what the component needs to do, including any optical, chemical, mechanical or assembly requirements.
Factors to consider include:
- Optical transparency or transmission.
- Chemical and reagent compatibility.
- Dimensional stability.
- Ability to reproduce fine features.
- Mechanical properties.
- Temperature exposure.
- Moisture characteristics where relevant.
- Joining, bonding or welding requirements.
- Applicable biological or regulatory requirements.
- Production volume and cost.
Depending on the application, potential materials may include polypropylene (PP), polystyrene (PS), polymethyl methacrylate (PMMA), polycarbonate (PC) and cyclic olefin copolymer or polymer (COC/COP). Don’t assume that plastics with similar characteristics are interchangeable.
Design for Manufacturing
An IVD manufacturer should involve an injection moulding partner before production tooling is finalised, ideally while the component can still be adjusted without significant rework. Early design for manufacturing (DFM) can identify features that may affect mouldability, consistency, tooling or downstream assembly before they become costly to change.
Important DFM considerations can include:
- Wall thickness and transitions.
- Draft and ejection.
- Gate and parting-line locations.
- Shrinkage and warpage.
- Critical dimensions and tolerances.
- Replication of fine features.
- Optical, sealing and mating surfaces.
- Assembly interfaces.
- Multi-cavity tooling requirements.
These decisions can have direct consequences in an IVD application. For example, a gate or ejector location could interfere with an optical surface, sealing area or fluid pathway. Likewise, a cartridge geometry that performs well as a machined or 3D-printed prototype may still need refinement before it can be reproduced consistently through production tooling.
From Tooling to High-Volume IVD Consumables Manufacturing
Moving an IVD consumable into repeatable production typically involves design for manufacturing, tooling, process development, validation, moulding, inspection and any required assembly or packaging.
Tooling and Scale
Production tooling should reflect the component’s geometry, tolerances, expected volumes and quality requirements. Cavity strategy, process controls and tool maintenance all influence whether a part can support the required output as demand increases.
Multi-cavity tooling and automated production may be best suited to mature IVD programmes with high annual volumes, provided cavity-to-cavity consistency and process control can be maintained.
Inspection and Process Control
Inspection should focus on the characteristics that are critical to the component’s function. Depending on the application, controls may include:
- Dimensional inspection.
- Optical or vision inspection where applicable.
- Functional testing where applicable.
- Validated and documented process parameters.
- Part, lot and process traceability.
- Change control.
- Ongoing monitoring for part-to-part and lot-to-lot consistency.
These controls help manufacturers identify variation before it affects downstream assembly or component performance.
Controlled Environments, Assembly and Packaging
Not every IVD consumable requires cleanroom manufacturing. The appropriate production environment depends on the component, its contamination risk, downstream use, assembly process and applicable customer or regulatory requirements. Some programmes may require controlled manufacturing or classified cleanroom production.
Consider assembly and packaging requirements as part of the manufacturing programme. IVD components can be automatically or manually assembled after injection moulding when the product requires additional components or joining operations. Planning assembly, welding, inspection or packaging alongside moulding can simplify the transition into production and provide better coordination across downstream operations.
What to Look for in an IVD Consumables Manufacturer
Choosing a diagnostic consumables manufacturer starts with the component’s critical-to-quality requirements, production stage and expected scale. The following criteria can help OEMs determine whether a manufacturing partner’s engineering, quality and production capabilities align with the programme.
| Capability | Why it’s important | What an OEM should evaluate |
| IVD experience | Optical, fluidic and dimensional requirements can vary significantly by application. | Experience with relevant IVD applications, component types and production requirements. |
| DFM/DFA and material expertise | Early design and material decisions affect mouldability, function, assembly and production consistency. | Engineering support before tooling is finalised, including material selection, mouldflow and design for manufacturing and assembly. |
| Tooling and precision moulding | Tool and process design affect dimensions, surfaces, fine features and repeatability. | Tool design and build expertise, process control, cavity strategy, maintenance and tolerance capability appropriate to the component. |
| Quality management and validation | IVD production may require documented, controlled and repeatable manufacturing processes. | Relevant quality systems and certifications, validation capabilities, documentation and change control. |
| Controlled or cleanroom manufacturing | Contamination-control requirements depend on the component and its downstream use. | Manufacturing environment and cleanroom classification appropriate to the programme's requirements. |
| Inspection and traceability | Variation can affect optical, fluidic, mechanical or assembly performance. | Dimensional, vision, optical or functional inspection as applicable, plus part, lot and process traceability. |
| Assembly and downstream operations | Cartridges and other multi-part consumables may require joining, inspection and packaging after moulding. | Manual or automated assembly, joining or welding, integrated inspection and packaging capabilities appropriate to the product. |
| Production scalability and long-term support | Successful programmes may need to move from development into sustained high-volume production. | Capacity, automation, cavity strategy, tool maintenance and ongoing engineering and production support. |
The right partner isn’t necessarily the manufacturer with the longest equipment list. Look for relevant IVD experience, DFM/DFA and material expertise, tooling and precision moulding capability, quality and validation systems, appropriate controlled manufacturing, inspection and traceability, downstream operations and production scalability. These capabilities should align with the component’s specific requirements and support the programme as it moves toward production.
When Sonoco Plastics Is a Good Fit for IVD Consumables Manufacturing
Sonoco Plastics can be a strong fit for IVD consumables manufacturing programmes that need support from early design and tooling through validated production and scale-up. Its Rotterdam operation supports medical device and diagnostic applications with DFM/DFA, mouldflow, developmental tooling, precision injection moulding, automated quality inspection, traceability, cleanroom manufacturing, assembly and packaging capabilities.
Sonoco’s experience with Alfa Wassermann Diagnostic Technologies provides one example of this work in practice. According to Alfa Wassermann CEO Peter Napoli, Sonoco has served as a manufacturing partner for nearly two decades, with precision-moulded components used in the company’s analysers. The relationship also reflects the responsiveness, consistency and collaborative problem-solving required in a regulated, precision-driven environment.[1.1]
Discuss your IVD consumable design, tooling, injection moulding, assembly or scale-up requirements with Sonoco Plastics’ medical device manufacturing team.
Frequently Asked Questions About IVD Consumables Manufacturing
Are IVD consumables usually single-use?
Many IVD consumables are designed for single use, particularly components such as cuvettes, cartridges, tips and other sample-handling parts. Single-use formats can support consistent workflows and help reduce the risk of carryover or contamination between samples. Requirements still depend on the diagnostic system and application.
Can injection moulding be used to manufacture microfluidic cartridges?
Yes. Injection moulding can be used to manufacture diagnostic cartridges with channels, chambers and other fine or microfluidic features. Successful production depends on factors such as feature geometry, material selection, tooling, sealing requirements and the ability to replicate those features reliably at the intended production scale.
Can injection-moulded diagnostic components include membranes or inserts?
Yes. Depending on the cartridge or diagnostic component design, membranes, filters or other inserts can be incorporated as part of downstream assembly. The moulded component should be designed with those assembly requirements in mind, including positioning, joining or sealing features and inspection needs.
