Breathing system for anaesthesia/ventilation of adults, paediatric patients and neonates
Its complexity is nearly impossible to surpass – just like the value of each individual life.
This included the design of the injection moulding tools, consulting in the selection of materials and supplier management as well as the subsequent assembly of components through to customer-specific packaging solutions, including logistics services.
The customer was specifically looking for advice on an optimum production concept and the best possible technological solution using plastic injection moulding; the focus was on designing components that could be manufactured from plastic, taking into account the technical requirements and specifications, including the mould concepts for the respirator system.
In addition, the individual injection-moulded parts had to meet the highest customer requirements in terms of tolerances, distortion and flatness. A total of 20 different materials are used, including PPS with 20% carbon fibre content, PPS with 40% glass fibre reinforced, PA12 with 30% glass bead reinforced, PPSU, LSR, steel and TPE. Strict quality assurance agreements are in place with the raw material suppliers and GPE to audit the mechanical and flow properties of each batch of material. The processing temperature sometimes exceeds 300 °C. The following production technologies were required: Plastic injection moulding, liquid and solid silicone injection moulding under class 8 clean room conditions to DIN EN ISO 14644-1, high-speed machining, laser marking, induction welding, assembly, 100% inspection, labelling and packaging in a class 9 clean room 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 the parts in antistatic ESD PE pouches, including label printing with a LOT no. and Data Matrix code, is carried out under class 9 clean room conditions to DIN EN ISO 14644-1. Complete documentation of incoming purchased parts and outgoing deliveries of saleable breathing systems is stored for each batch by GPE using a CAQ system, including test certificates.
Project realisation by GPE meets the highest standards with respect to plastic-compatible component design and tooling concepts with inspection of functionally relevant test dimensions for each part during production, e.g:
- Flatness < 0.20 mm
- Plane parallelism < 0.20 mm
- Tolerances in some cases < 0.10 mm
- Stress cracking resistance
- Impermissible, open-pored surface structures, voids or vacuum voids
GPE developed special injection moulds for processing the high-performance plastic PPS-CF20 for the breathing system’s two large parts (the cover and housing). In the process, GPE demonstrated its unique capabilities in numerous details:
- Due to the very high abrasive influences and processing temperatures of the raw material, corresponding basic tooling requirements are standardised at GPE. In addition to special screw geometries to ensure the melt is conveyed smoothly and homogeneously, these include fully armoured and thus wear-resistant injection units and screw fittings.
- Due to the extreme demands on service life, the abrasive and highly aggressive influences on the raw material as well as the extremely high heat effect of centrally integrated heating systems, the individual injection moulds are made of specially tempered steels.
- In addition, specially developed special coatings inside the injection moulds prevent the raw material from sticking to the cavity and at the same time facilitate the removal of gases during the mould filling process. Here, the advantages of a superior and low-stress demoulding, mould venting (gas accumulation = burner) and the prevention of deposits (mould fouling) are clearly evident.
- Multiple temperature sensors in combination with impulse cooling (using air as the medium) selectively regulate the thermal equilibrium in the mould during the injection process, enabling significantly shorter residual cooling times to be achieved compared to liquid media thanks to the targeted dissipation of heat during the cooling and solidification phase of the melt within the cavity. This process also makes it possible to produce parts with low stress and thus to meet customer requirements for flatness and dimensional accuracy – a clear advantage over processes that use water and oil tempering. The cavity pressure system calculated and integrated via pressure simulation produces an automatically controllable, extremely constant and reproducible injection moulding mass production process.
- Thanks to the use of a built-in, pneumatically controlled valve gate system, it is possible to substantially reduce raw material and production costs by eliminating sprue connections and removing them later. The associated positive environmental aspects are standard at GPE.
GPE developed a smart production concept for component assembly according to customer specifications, met the highest quality standards of quality with respect to the assembly of the individual parts to one another, and carried out the assembly, testing and packaging in a class 9 clean room according to DIN EN ISO 14644-1. Each module was fully tested with regard to flow rate, seal and overpressure. GPE assumed responsibility of the complex process of managing the suppliers of purchased parts (secondary parts) including packaging materials; this also included several certified suppliers specified by the customer. GPE integrated itself into the customer’s existing supply chain abd handled the complete quality documentation (DIN-ISO documentation) of the final product – from the raw material to labelling. Batch traceability of all components back to the raw material used is also guaranteed by means of laser marking with UDI coding.
The Added Value
The breathing system can be disassembled and prepared for sterilisation (autoclaving) in ten simple steps by the nursing staff. It is easy to handle, can be easily connected, disconnected and opened thanks to quick-release fasteners on the cover. It thus plays an important role in improving clinical processes.
The breathing system ensures the patient remains safe via protective lung ventilation in the operating theatre, thus helping to avoid post-operative pulmonary complications (PPC), one of the most common afflictions of the respiratory system under general anaesthesia.
The breathing system is used to generate a pressure or flow rate with the blower and thus ensure that the patient is properly ventilated. The newly developed breathing system can be used in the anaesthesia of adults, paediatric patients and neonates.
MORE Product Cases
Spacer for metered-dose inhalers
Effective asthma treatment for infants and toddlers up to six years of age thanks to ‘Great Performance Engineering’ – the spacer, an important inhalation aid, creates the necessary minimum distance and thus enables the formation of an aerosol cloud suitable for children.
Anaesthesia equipment trolley chassis
The perfect foundation for the complete assembly of the entire trolley system thanks to ‘Great Performance Engineering’ – the chassis for anaesthesia machines meets the tightest tolerance specifications, thus minimising deviations in further assembly and ensuring the desired quality.