G_Great
P_Performance
E_Engineering
High-quality expiration valve that improves safety and quality in intensive care ventilation.
During the coronavirus pandemic, GPE fully met soaring increases in demand thanks to its fractal manufacturing structures.
Unique development and manufacturing expertise in plastic and liquid silicone injection moulding as well as module assembly.
Disposable RFID expiration valve for intensive care ventilation
In times like these, each and every lifesaver plays a critical role. This one is one of a kind.
Versatile use in intensive care ventilators thanks to ‘Great Performance Engineering’. The disposable RFID expiration valve for intensive care ventilation conducts contaminated gas from the patient containing secretions. RFID technology ensures that each valve is used for the correct period of time and allocated to the right patient. In close collaboration with the customer, GPE developed and defined well-engineered and stable manufacturing processes, assumed responsibility for the complex production process, supplier management as well as module assembly right through to saleable final packaging, including logistics services. Maximum quality in use is achieved through the perfect interaction of the wide variety of materials and component tolerances.
The Task
Production of the expiration valve (disposable) for intensive care ventilators This included, among other tasks, designing the injection moulding tools and supplier management as well as the subsequent component assembly including testing right through to the saleable final packaging, including logistics services.
The Challenges
The complex product had to meet stringent customer requirements with respect to tolerances, distortion and flatness for the various individual injection-moulded parts. The use of different materials – PP, PE, PC, LSR, steel and TPE – required a wide range of manufacturing technologies. Since the (disposable) expiration valve consists of eleven different components, all of the individual parts must meet the highest standards of quality before they can be assembled into the final module. If a relevant functional test dimension is not accurate in only a single component, the complete assembly of the disposable ventilation valve may fail the final test.
The Solution
GPE assumed responsibility for designing the eight injection moulds for the functional components, enabling the compatibility of the items both individually and with each other to be achieved very quickly, and developed a smart production concept for component assembly according to customer specifications. GPE’s solution meets the most stringent requirements in terms of plastic component design optimised for injection moulding and tooling concepts with in-process testing of functionally relevant test dimensions for each item, as well as the highest quality criteria with respect to the assembly of the individual parts.
Each ventilation valve is subjected to a full mechanical, optical and pneumatic functional check using customer-specific testing equipment. The RFID components (antenna and transponder) of each valve are programmed with the current batch number (production order number) in the test device. This ensures that each valve is fully traceable in use and ready for immediate use at the hospital.
GPE carried out assembly, testing and packaging in a class 9 clean room according to DIN EN ISO 14644-1 and fully tested each assembly with regard to flow rate, seal and overpressure. In addition, GPE handled the complete quality documentation (DIN-ISO documentation) of the final product, from raw materials to country-specific labelling. The production technologies utilised comprised one- and two-component plastic injection moulding, liquid silicone injection moulding under class 8 clean room conditions according to DIN EN ISO 14644-1 with assembly and packaging in a class 9 clean room according to DIN EN ISO 14644-1.
Supplier management for all of the assembly’s components, right down to the packaging material, is fully handled by GPE. Sealing and packaging in PP foil pouches including label printing with LOT-No. and Data Matrix coding is carried out under clean room conditions. Complete documentation of incoming purchased parts and outgoing deliveries of saleable ventilation valves is stored for each batch by GPE using a CAQ system, including test certificates.
Each ventilation valve is subjected to a full mechanical, optical and pneumatic functional check using customer-specific testing equipment. The RFID components (antenna and transponder) of each valve are programmed with the current batch number (production order number) in the test device. This ensures that each valve is fully traceable in use and ready for immediate use at the hospital.
GPE carried out assembly, testing and packaging in a class 9 clean room according to DIN EN ISO 14644-1 and fully tested each assembly with regard to flow rate, seal and overpressure. In addition, GPE handled the complete quality documentation (DIN-ISO documentation) of the final product, from raw materials to country-specific labelling. The production technologies utilised comprised one- and two-component plastic injection moulding, liquid silicone injection moulding under class 8 clean room conditions according to DIN EN ISO 14644-1 with assembly and packaging in a class 9 clean room according to DIN EN ISO 14644-1.
Supplier management for all of the assembly’s components, right down to the packaging material, is fully handled by GPE. Sealing and packaging in PP foil pouches including label printing with LOT-No. and Data Matrix coding is carried out under clean room conditions. Complete documentation of incoming purchased parts and outgoing deliveries of saleable ventilation valves is stored for each batch by GPE using a CAQ system, including test certificates.
The Added Value
In close collaboration with the customer, GPE developed and defined well-engineered and stable manufacturing processes. GPE handles the process of managing the suppliers of purchased parts, including smart scheduling. The customer receives the quantities required from GPE in a highly responsive, forecast-driven process, delivered directly to its VMI warehouse. Since GPE carries out the process of harmonising the plastic components relative to each other, the customer no longer needs to coordinate with multiple suppliers. They achieve maximum quality with respect to the assembly of the disposable expiration valve, because in this case the most important aspect is the interaction of the wide variety of materials and component tolerances in each drawing.
Due to the fractal structures in the assembly lines, it is possible to respond extremely quickly to order fluctuations. GPE was able to realise short-term demand increases of 100%, even in the midst of the coronavirus pandemic. In this context, GPE serves the customer as a full-service supplier and TIER ONE supplier.
Due to the fractal structures in the assembly lines, it is possible to respond extremely quickly to order fluctuations. GPE was able to realise short-term demand increases of 100%, even in the midst of the coronavirus pandemic. In this context, GPE serves the customer as a full-service supplier and TIER ONE supplier.
The Application
The expiration valve is used for intensive mechanical ventilation and lung monitoring. The expiration valve is used to control the breathing phase and positive end-expiratory pressure (PEEP). The valve conducts contaminated gas from the patient containing secretions. RFID technology ensures that the valve is used for the correct period of time and allocated to the right patient. The benefits of non-invasive ventilation with disposable expiration valves include maintaining hygienic standards, given the continuous increase in nosocomial infections in hospitals, as well as improving clinical processes and supporting caregivers. The disposable valves are easy to use; the bayonet locking mechanism allows for quick connection and simple operation. Because they are only used with a single patient, the valves also reduce the risk of ventilator-associated pneumonia (VAP).