Sanner collaborates with PulmoBioMed to achieve CE certification for PBM-Hale™ Deep-Lung Breath Sampling Platform

GERMANY—Sanner, a device design specialist and contract development and manufacturing organization, has partnered with PulmoBioMed Ltd to secure CE marking for the PBM-Hale™, a deep-lung breath sampling platform.

Through this approval, the device becomes the first technology to deliver saliva-free, non-invasive samples from the deep distal lung, enabling clinical and research use across Europe and the United States.

Traditionally, clinicians rely on invasive procedures to obtain deep-lung samples, which are costly, risky, and limited to critically ill patients and therefore unsuitable for routine testing.

As a result, many underlying causes of lung disease remain undetected, while treatment often focuses on symptoms rather than root causes.

PulmoBioMed, a UK-based medical device company, developed PBM-Hale™ to challenge invasive diagnostic methods and advance respiratory research through non-invasive breath sampling.

The device collects saliva-free exhaled breath condensate from the distal lung while minimizing contamination from the mouth, upper airways, and environment, and it integrates into standard diagnostic workflows.

To accelerate development, PulmoBioMed partnered with Sanner, which provided full design support, regulatory guidance, and scalable manufacturing expertise under an ISO 13485-certified quality system.

Design and Engineering Process

Sanner UK engineers guided the product through structured development, including risk analysis, prototype testing, design iteration, and tolerance assessment to ensure reliable performance.

The teams also used 3D modelling and mold-flow simulations to refine the 17-component design for injection molding and large-scale assembly.

Early design transfer experts supported manufacturability decisions, ensuring material selection, tooling, and assembly met both regulatory and functional requirements.

Together, both companies streamlined the design-to-production pathway, aligning engineering output with regulatory expectations to support consistent device quality.

This integrated approach reduced development cycles while enabling rapid transition from prototype validation to commercial-scale manufacturing.

Manufacturing and Quality Validation

Following verification and installation and operational qualification (IQ/OQ), Sanner produced the first 3,500 units in a Class 7 cleanroom to meet regulatory standards.

Dr. Sterghios A. Moschos, founder and CEO of PulmoBioMed, said he was impressed by the transition from prototype to injection-molded product and the consistency of manufacturing quality.

In addition, Sanner developed the primary packaging, branded secondary cartons, and tertiary multi-packs required for safe shipment of PBM-Hale™.

Market Rollout and Future Plans

With CE marking secured, PulmoBioMed plans to deploy PBM-Hale™ in clinical trials and partnerships with diagnostic, pharmaceutical, and biotechnology companies across Europe and the United States.

The company aims to improve lung disease diagnostics by making sampling less invasive, more accessible, and easier to integrate into routine healthcare systems.

Dr. Moschos added that PulmoBioMed expects to scale global supply of PBM-Hale™ in collaboration with Sanner as demand expands.

Sanner also ensured cleanroom production readiness, validated assembly processes, and supported logistics planning to maintain quality control throughout initial production batches and subsequent scale-up activities for PBM-Hale™ deployment across international markets in Europe and the United States respectively.