Reusable expiration valve for intensive care ventilation in neonatology and paediatrics
Sometimes it takes more than love to get life off to a good start – like sensitive engineering.
Manufacture of the reusable expiration valve for various intensive care ventilators in neonatology and pediatrics. This included the planning of the injection molding tools, the supplier management and the subsequent assembly of components through to the customer-specific packaging solution including logistics services.
The customer was specifically looking for advice on the selection of materials, because as a reusable item, the expiration valve should be dismantled by the nursing staff after use on the patient and autoclaved at 134 ° C. The sterilization process and the required duration of use resulted in special requirements for the selection of materials for the various items: The raw materials must meet defined mechanical and thermal requirements and have properties such as: Biocompatibility, Medical grade Class, Laserbatch, heat stabilized for a low tendency to warp and chemical resistance.
Furthermore, the highest customer requirements applied to the various individual parts in injection molding with regard to tolerances, warpage and evenness. The use of different materials – PA12, reinforced with 30% glass beads, PSU, LSR, steel and TPE – required a wide variety of manufacturing technologies under clean room conditions. Since the reusable expiratory valve consists of 18 different components, all individual parts must meet the highest quality requirements before they can be assembled into the final assembly. If a relevant functional test dimension is incorrect in just one of the components, the entire assembly of the reusable ventilation valve can fail the final test.
GPE took on the project planning of the eleven injection molding tools for the functional items, so that the items could be coordinated very quickly, both individually and with one another, and developed process-reliable production technologies for connecting metal with liquid silicone to the tightest drawing tolerances as well as a smart production concept for component assembly according to customer specifications. The GPE solution meets the highest requirements for plastic-compatible component design and tool concepts with production-accompanying tests of function-relevant test dimensions for each article, as well as the highest quality criteria in the assembly of the individual parts.
GPE carried out assembly, testing and packaging in a class 9 clean room in accordance with DIN EN ISO 14644-1 and tested each assembly for flow rate, tightness and overpressure. Each ventilation valve is 100% mechanically, optically and pneumatically subjected to a functional test on customer-specific test devices. In the test device, the RFID components (antenna and transponder) of each valve are linked to the current batch number. (Production order no.) Programmed. This ensures the required traceability of every valve in use and prepares it for immediate use in the hospital. In addition, the complete quality documentation (DIN-ISO documentation) of the end product from the raw material to the labeling was carried out. 1- and 2-component plastic injection molding, liquid silicone injection molding under clean room conditions class 8, assembly and packaging in clean room class 9 according to DIN EN ISO 14644-1 are used as manufacturing technologies.
GPE controls the complete supplier management from purchased parts (secondary parts) to the packaging material – with certified suppliers, some of which are specified by the customer, and fits into the customer’s existing supply chain. Sealing and packaging in antistatic ESD PE bags including label printing with LOT no. and data matrix coding takes place under class 9 clean room conditions according to DIN EN ISO 14644-1. The entire documentation of incoming goods for purchased parts and outgoing goods for salable ventilation valves is saved for each batch, including test certificates from GPE, using the CAQ system.
THE ADDED VALUE
Together with the customer, GPE developed and defined well thought-out and stable manufacturing processes. GPE takes over the supplier management of the purchased parts including smart scheduling. The customer receives forecast-controlled his needs in a highly reactive manner from GPE and others. delivered to his VMI warehouse. Because GPE coordinates the plastic and silicone parts with one another, the customer does not have to coordinate several suppliers. He receives the best quality with regard to the system assembly of the reusable expiration valve, because here it depends on the interaction of the most diverse materials and component tolerances per drawing. Due to the fractal structures in the assembly lines, it is possible to react very quickly to fluctuations in orders. Especially in the corona pandemic, GPE was able to realize short-term increases in demand of 100%. For the customer, GPE acts as a full service supplier and TIER ONE supplier.
The reusable expiration valve is used for intensive ventilation and lung monitoring. The expiratory valve is used to control the breathing phases of various intensive care ventilators that are used in neonatology and pediatrics for invasive / non-invasive ventilation. The valve directs contaminated and secretion-containing patient gas. RFID technology guarantees the duration of use and patient allocation of each valve. After use, the ventilation valves can be sterilized in the autoclave at 134 ° C using superheated steam.
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