Drug inhalation device

Through close cooperation with pharmaceutical companies, the Grasheim Medical Systems Division has been developing and producing powder inhalation devices, capsule inhalation devices, and nebulizers for the treatment of respiratory diseases such as asthma, COPD (chronic obstructive pulmonary disease), and cystic fibrosis for over 20 years

Design, development, and contract manufacturing of medication inhalation devices.

Through close cooperation with pharmaceutical companies, the Grasheim Medical Systems Division has been developing and producing powder, capsule, and nebulizers for the treatment of respiratory diseases such as asthma, COPD (chronic obstructive pulmonary disease), and cystic fibrosis for over 20 years. We can produce over 100 million inhalation devices annually and are a leader in the field of inhalation devices.

Gracheim empowers you

Our annual production exceeds 100 million drug inhalation devices, and we are experienced experts in the field of customer specific inhalers used for inhalation therapy.

As a comprehensive service provider, we are responsible for all stages of the value creation chain, from planning to the launch of products for sale. From concept development, industrial design, product development, production equipment design, mold manufacturing, and specialized mechanical engineering to large and small batch production, module assembly, drug assembly and filling, sterilization, and packaging in sterile rooms according to ISO 14644-1 ISO levels 7, 8, and 9 standards under FDA/GMP conditions - with Gracheim Medical Systems, you can get all services in one stop.

3. Gresham Medical Systems develops products based on specifications or optimizes the layout of injection molded components according to your ideas. Therefore, our engineers have already started incorporating the manufacturing phase into the design considerations during the development stage of the drug inhalation device. For you, this means reducing development time, development costs, and project risks. Our design and development experts collaborate closely with the Department of Special Purpose Mechanical Engineering. Through this method, we ensure that each injection molded part and assembly unit can be smoothly assembled after production, and guarantee optimal functional safety.

During the development phase, we conduct small-scale production in sterile rooms that comply with ISO 14644-1 ISO-8 standards, providing you with another significant time benefit. Here, we produce small batches according to requirements as test samples for clinical trial research. If you further request, we can also provide filling services. Our service scope also includes the evaluation of inhalers and systems, including providing complete records (such as device master files) as the basis for product approval.

5. The entire value creation chain, from precision injection molding in large and small batches, to fully automatic, semi-automatic, and manual assembly of plastic parts, assembly units, and metal parts, to precision machining and packaging of products, is carried out in sterile rooms that comply with ISO 14644-1 ISO levels 7 and 8 standards.

Our specialized mechanical engineering department has designed and established an assembly system that can feed plastic and metal components with high precision at the highest speed. At the same time, we ensure the optimal surface quality and functional safety of the product through gentle assembly of visible surfaces and visual inspection of visible component damage within the assembly system. We conduct 100% full process testing on assembly steps, assembly units, and product functions through a large number of intelligent camera systems and testing stations in the assembly system.

As experts in the combination of plastic and metal, we can also be responsible for assembling electronic components in drug delivery inhalation devices as required, including electronic counters for measurement, nebulization actuators, and various sensors. We integrated the punch press contacts and installed the circuit board, then designed it into devices such as switches. For example, during inhalation, the volume switch triggers the application of medication after testing the patient's correct inhalation. We have established our own sterile room for the assembly of electronic devices. These devices are also equipped with special ESD protection flooring to prevent static electricity. The special camera testing in the assembly system ensures the accurate insertion position of the circuit board, non-destructive positioning and snap in installation of punch components, and accurate switch position. The seamless online functional testing of the assembly system makes our service scope more comprehensive.

8. Miniaturization is one of the important technological trends. More and more functions are being integrated into inhalers, resulting in components becoming smaller and requiring higher precision. To meet these requirements, we use modern injection molding technology to produce inhalers, such as micro injection molding technology.

9. Our branch in China, Gresheim Plastic Products (Dongguan) Co., Ltd., is a medical equipment manufacturer that has passed FDA inspection and produces inhalers for the treatment of cystic fibrosis. In terms of obtaining drug approval for inhalers in the US market, the entire value creation chain has been closely reviewed according to strict standards. This includes the purchase of rubber and metal components, injection molding of inhaler plastic components, assembly and testing of inhaler plastic components, laser printing, and review of original seals. Injection molding, assembly, testing, and component sealing are all carried out in sterile rooms that comply with ISO 14644-1 ISO Level 8 standards.

10. We produce inhalers globally, including Pframd in Germany, Holsovskitten in the Czech Republic, Peachtree City in the United States, and Dongguan City in China. The prerequisite for producing inhalers is to have environmental conditions that meet the standards. Therefore, Gresheim Medical Systems provides approximately 60000 square meters (670000 square feet) of sterile room areas worldwide, all of which comply with ISO 14644-1, ISO 7, 8, 9, and GMP C and D standards.