Ensuring the safety, efficacy and consistency of these devices requires not only precise mixing and dosing technologies, but also advanced assembly solutions that meet the highest standards of quality and compliance.
DPIs pose unique challenges: the powders involved are often highly potent, requiring micro-dosing accuracy, high containment and real-time weight control to ensure patient safety and therapeutic effectiveness. Moreover, the assembly of inhalers must be flexible, scalable and capable of integrating multiple components, from powder mixing, dosing and capping to welding and packaging.
IMA Active, with decades of expertise in solid dose processing, offers cutting-edge solutions for DPI mixing and capsule filling. Its technologies incorporate gravimetric direct net weight control by real gravimetric scale featuring 0.1 Sigma, automatic feedback systems and continuous calibration, all designed to ensure exceptional dosing precision without compressing or aspirating the powder. These systems are engineered to support a wide range of production needs, from clinical trials to full-scale no-stop manufacturing.
Machines like the ADAPTA and PRECISA series are built to handle outputs from low to high volumes, combining speed, reliability and full GMP compliance. Completing the portfolio, MINIMA — a compact, table-top volumetric capsule filler — has shown to achieve high repeatability and accuracy even at very low dosages, making it an ideal solution for early-stage development and clinical trials of DPI formulations.
The capsule filling machine ADAPTA and the weight checkers PRECISA
The ADAPTA capsule filling machines cover low, medium and high-speed production requirements and feature exceptional design flexibility. They fit special dosators for DPIs that can be accurately adjusted without any need to compress or aspirate the powder. Maintaining the properties of the dispensed powder within the capsule better ensures the release of powder from the capsule into the inhaler when the capsule is pierced, perforated or cut. This leads to improved control over both the emitted dose and the fine particle fraction of the dose discharged from the DPI.
Besides this, ADAPTA enables 100% gravimetric direct net weight control via an exceptionally accurate system embedded within the machine, ensuring maximum dosing precision and reliability even at high speeds. Its reliability and repeatability are ensured by two zeroing cells to guarantee precise weight measurement. These weighing cells provide a zero value at the beginning of each operation, allowing for real-time compensation of any weight fluctuations.
PRECISA weight checkers are conceived for 100% weight control and selection of pharmaceutical products packed in hard gelatine and HPMC capsules. PRECISA can be used to pre-weight empty capsules using 0.1 mg S.D. as it uses an extremely reliable product transfer system to the weighing cell that minimises vibrations. After weighing, any out-of-weight products are rejected.
The best solutions for DPI processing by IMA Active
However, the manufacturing of Dry Powder Inhalers (DPIs) begins with the blending of a fine Active Pharmaceutical Ingredient (API) with larger carrier particles to achieve a homogeneous mixture and deagglomerable powder formulations. The objective is to ensure adequate adhesion of API particles to the carrier, allowing detachment upon inhalation for efficient pulmonary drug delivery. This process necessitates precise control of variables such as mixing energy, duration, speed, and the sequence of ingredient addition to optimise performance and avoid issues such as insufficient adhesion or excessive agglomeration. This is why IMA Active can also provide ROTO MIX high-shear mixer granulators designed for the dry mixing of powders. Mixing of powder particles is achieved by the combined and gentle action of impeller and chopper.
Moving our focus now to IMA Automation’s medical device assembly business unit, IMA MED-TECH brings deep expertise in automated medical device assembly to the DPI sector, providing tailored solutions that range from early-stage prototyping to full-scale commercial production. Drawing on decades of experience in medical device automation, the business unit combines engineering precision with process flexibility to meet the evolving needs of the pharmaceutical industry.
The assembly of DPIs presents unique challenges, requiring not only the assembly of multiple components, but also the assurance of dosing accuracy, device integrity and regulatory compliance. IMA MED-TECH addresses these needs through platforms that incorporate powder dosing, capping, component assembly, welding, vision inspection and packaging, all within a modular and scalable architecture.
One of the key strengths of IMA MED-TECH lies in its ability to support customers throughout the entire product lifecycle. From proof-of-principle studies and design-for-manufacturing evaluations to risk analysis and automation scale-up, the division ensures that each device is optimised for performance and manufacturability. This approach significantly reduces time-to-market and minimises the risk of costly redesigns.
Among the most representative technologies in the DPI portfolio are the ASSEMBLA 20 and ASSEMBLA 200 platforms.
Semi-automatic solution for laboratory environments, ASSEMBLA 20
ASSEMBLA 20 is a semi-automatic solution designed for laboratory environments, clinical trials and early-stage production. Its compact footprint and manual loading configuration make it ideal for functional builds and process validation. Despite its low output (up to 20 parts per minute), the machine replicates critical production processes with the same precision found in high-output systems. It supports various transport systems, including free-flow pallet, cam-driven, rotary dial and magnetic, complying with CFR Part 11 standards.
For high-speed commercial production, ASSEMBLA 200 offers a fully automatic platform capable of reaching outputs of up to 200 parts per minute. It features single or double-sided configurations, robotic integration and servo-driven workstations. The system is compatible with leading control platforms and can be linked to automated material handling solutions to streamline operations. Its modular design allows for flexible multi-cell configurations, enabling manufacturers to adapt quickly to changing production demands.
Both platforms are part of a broader strategy that focuses on precision, repeatability and scalability. Whether producing small batches or scaling up to 24,000 inhalers per hour, IMA MED-TECH provides the tools and expertise to ensure consistent quality and efficient throughput.
With its deep understanding of inhaler assembly and its commitment to innovation, IMA MED-TECH stands as a strategic partner for pharmaceutical companies seeking reliable, integrated solutions for DPI manufacturing.
One partner, one vision: integrated DPI solutions
The synergy between IMA Active and IMA MED-TECH creates a unique value proposition for pharmaceutical companies: a single, integrated partner capable of delivering both processing and assembly solutions for DPIs. This collaboration ensures a streamlined workflow, reduced lead times, and optimised device performance, making IMA the ideal All-In-One Supplier for DPI production.
