Elcam Safety
Elcam Drug Delivery Devices
At a glance
- The shift toward biologics in pharma is increasing demand for flexible, single-use bioprocess systems
- To meet this need, Elcam Medical is extending its 50 years of OEM medical manufacturing experience into single-use bioprocessing components
- Elcam’s initial bioprocess family includes manifolds, stopcocks, valves, sensors, and Safe2 Rotator components with built-in barb connectors to reduce the need for extra adapters, simplify assembly, and lower risk.
- Intended for integrators and CDMOs, the product line combines easier integration, customization, and clean-room manufacturing expertise
The bioprocess revolution in pharmaceuticals
Over the last decade, drug manufacturing has shifted toward more specialized therapies and smaller patient populations. The growing use of biologics—including monoclonal antibodies, vaccines, biosimilars, and cell and gene therapies—has made bioprocessing central to modern drug manufacturing. The global bioprocessing market is projected to reach USD 277.4 billion by 2035.
As products become more specialized, production runs become smaller and changeovers more frequent. In response, bioprocess has gradually embraced single-use systems.
“That shift has increased demand for components designed specifically for regulated, disposable production environments,” says Michael Segev, Chief Business Officer with Elcam Medical.
And that, in turn, has given Elcam, an established supplier to the medical device industry, a clear entry point into single-use flow-control components for bioprocessing.
Bioprocess: The opportunity
Bioprocess depends on controlled fluid paths, biocompatible materials, validated performance, and clean-room manufacturing environments like ISO class 7 and ISO class 8. Some gamma-sterilized equipment moves into even stricter conditions such as ISO class 5. These requirements align closely with Elcam’s experience in OEM single-use components and regulated manufacturing as applied to biopharma manufacturing components.
According to Segev, “Bioprocess was a strong fit for Elcam because it builds directly on capabilities we already know well, especially in disposable flow control and regulated component manufacturing.”
Bioprocess puts that kind of detail-oriented engineering to use in an exciting new way. A valve design can make a set easier to prime and easier to handle during use. A component change can reduce extra parts or make a set easier to sterilize. A better fit within the system can simplify purchasing, assembly, and production planning.
Elcam has built its OEM business around solving these kinds of component-level problems.
Bioprocess in practice
Bioprocess systems contain many interconnected parts. Each part must match the application, the assembly, and the production environment. By supplying components engineered to fit those requirements cleanly and reliably, Elcam is bringing the same collaborative OEM approach to bioprocess that has shaped its medical-device business for years.
Some existing Elcam customers are already active in bioprocess. “As we looked more closely at bioprocess,” says Segev, “we saw clear overlap with customers already working in the field. That gave us confidence that we could bring relevant solutions into this space.”
Elcam selected its initial bioprocess offerings by looking closely at how these systems are assembled. It then identified where proven components could be adapted more effectively. For example, in the medical world, Luer connectors are the gold standard. In bioprocess assemblies, on the other hand, barb-based connectors are more common. This means many integrators and contract development and manufacturing organizations (CDMOs) must include extra Luer-to-barb adapters to connect incompatible components. This adds unnecessary assembly steps and complexity, along with increasing the cost. Each adapter also adds one more potential point of failure.
Elcam’s bioprocess family will include built-in barb connectors. That will help integrators and CDMOs reduce parts, simplify assembly, and create a cleaner fit within the system. The product line will include manifolds, stopcocks, valves, sensors, and Safe2 Rotator components, for both upstream and downstream use. The product line also includes sensors adapted for monitoring pressure, pH, CO2, and conductivity under controlled process conditions.
Five Decades of Reliable Manufacturing
“We bring more to bioprocess than products alone,” Segev says. With over fifty years of experience in OEM supply, regulated manufacturing, and disposable medical components, Elcam understands the production and integration demands that come with complex assemblies.
That’s especially useful for product customization. In bioprocess, off-the-shelf parts aren’t always enough. A customer may need a different connector format, a configuration change, or an adaptation that improves fit within the assembly. That’s especially relevant in areas such as cell and gene therapy, where smaller tubing sizes and specialized single-use assemblies are becoming more common.
Elcam’s engineers, project managers, and manufacturing facilities have the proven capability to develop components around real application needs. They work step by step from design input to development to production, transforming concepts into real-world products manufactured affordably and at scale.
Segev sums up Elcam’s enthusiasm for the field. “Bioprocess is a challenging field, and that’s exactly what makes it such an important one. It’s a space where the right combination of component expertise, manufacturing discipline, and partnership can create real value.”
Elcam’s experience in clean-room production, molding, and automated production, along with global manufacturing capability and hardened supply chains means Elcam offers customers not only a supplier of bioprocessing OEM components but a true partner for long-term success.
For more information on Elcam’s new bioprocess family of products, click here.
Elcam Medical Bioprocess Family FAQ
What is Elcam’s bioprocess product family?
Elcam’s bioprocess product family extends Elcam’s expertise in single-use flow-control components into bioprocess assemblies designed for regulated manufacturing environments.
Which bioprocessing applications are Elcam’s components designed for?
These components are designed for upstream and downstream bioprocess applications such as sampling, fluid transfer, and sensor-based monitoring within single-use drug-production assemblies.
Why are barb connectors important in bioprocess assemblies?
Barb connectors match the most common tubing formats used in bioprocess applications. Their use reduces the need for Luer-to-barb adapters, simplifying assembly and reducing potential points of failure.
What types of components are included in Elcam’s bioprocess family?
Elcam’s bioprocess family includes manifolds, stopcocks, valves, sensors, and Safe2 Rotator components built for regulated manufacturing environments, including ISO 7 and ISO 8 clean-room conditions.
