RAPID OPTIMISATION AND INDUSTRIALISATION

Transcription

1 RAPID OPTIMISATION AND INDUSTRIALISATION Cultivation of different cells in a fully automated module is made possible through a specially developed and patented closure for cell culture bottles. Mythentec was involved in the development of new functionalities in the closure required for automation and revised the 3D data to ensure its suitability for plastic. Moreover, there was also a demand for industrialisation of all plastic parts and downstream processes in minimum time. Re-engineering of all plastic parts in accordance with requirements and in close cooperation with the customer was successfully achieved in only one week. Development and integration of additional functions allowed the pre-assembly of a module and elimination of silicone seals. As a consequence, Mythentec also created the conditions for a simplified and more cost-effective production process. The required injection moulds were obtained from a competent partner in China and were available in only eight weeks for initial sampling. Each part of this project requires a different moulding technique. Methods employed include two-component injection, multi-slider tools with and without conversion options for product variants, a mould with a core puller required for a complex part geometry and a boring tool for creating the required thread. Mythentec takes care of the sophisticated welding of diaphragms in filter components with subsequent testing of the weld and airflow. The module is then assembled in five steps and sent as a complete set for external sterilisation. Further processing is realised under enhanced hygienic conditions, and Mythentec guarantees consistent batch traceability. Procurement and commissioning of tools abroad Industrialising of ultrasonic welding and installation Further processing under enhanced hygienic conditions Complex moulds from China prove to be successful with close cooperation and support. The diaphragm responsible for air dispensing and cleaning is welded in place using ultrasonic welding. The gold-plated magnets are fitted under enhanced hygienic conditions.

2 LOW INITIAL COSTS, SUPERIOR-QUALITY PRODUCT DAYSY is an intelligent ovulation calculator with app support that records individual menstruation cycles and evaluates these for birth control or pregnancy planning. With regard to the newly developed class 1 medical device, all plastic components were to be optimised for the customer in terms of the production process and responsibility taken for the planning and realisation of series production. Together with the engineering company responsible for development, the plastic parts were appropriately designed and adapted to suit further processing steps. A total of five moulds were manufactured in China at the facilities of competent local partners and sampled as well as optimised onsite by Mythentec. Mythentec selected the material to suit biocompatibility requirements (USP class VI and EN ISO 10993). A 1+1 mould for the casing components ensures that superior quality is produced at low initial costs. The upper casing component, which is the core part of the device, is produced by means of two-component injection (ABS-PC/TPE). The associated light conductor was designed to convey the light as desired and, following insertion, not to fall out during further processing steps. The master computer system ensures batch traceability of raw material and continually archives actual injection moulding cycle parameters on the server. Under enhanced hygienic conditions, Mythentec employs ultrasonic welding to weld the two cap halves together. All parts are ordered according to framework agreements. As a consequence, Mythentec can ensure that continuous stocks are available when costumer orders are placed at short notice. Component design suitable for plastic Low initial costs through mould procurement in China Assessment and optimising of moulds in China Ultrasonic welding under enhanced hygienic conditions Complete batch traceability of raw materials Moulds from China were sampled and optimised on-site by Mythentec. The light conductor is measured on the measuring microscope and the visual quality inspected using transmitted light. Two identical components are welded together using ultrasonic welding to form a protective cap.

3 FROM INITIAL IDEA TO SERIES PRODUCTION This indicator illustrates the cleaning effect of dishwashers for contaminated surgical instruments in the simplest possible form. As the customer wished to eliminate critical, design-related problems with standard indicators and to introduce its own improved product, they commissioned Mythentec to develop a functional indicator optimised in terms of its informative value. Prerequisite was the product s compliance with the EN ISO standard for washer-disinfectors. Work at Mythentec ranged from development of an optimised design right through to series production, resulting in a solution that achieves clear, unequivocal information on cleaning quality. Mythentec presented a complete concept in less than 60 development hours, which encompassed a technical specification, 3D design, material selection and prototypes. All other suppliers (e.g. for punched parts or packaging) were evaluated and commissioned by Mythentec. The transparent cover plate was manufactured in a 4-cavity mould using medical grade polycarbonate. The moulding has four snap fasteners and flights that define the four chamber heights of the indicator ranging from 0.75 to 2 mm. Regular component inspection is realised through IPC (in-process control), with the central master computer system continually archiving actual parameters. Mythentec supplies the unit ready for sale and, because of the direct procurement of all purchased parts, is the central contact for the customer. Each manufacturing step is carried out on the company s site and must meet enhanced hygienic requirements. Sheep blood is applied to the carrier plates in a machine prior to the assembly of the plastic components. The finished indicators are individually packaged, sealed air-tight and placed in sales boxes. The exact batches involved in all packaging units can be traced accurately through the labels. Direct procurement of all purchased parts Blood application, assembly and packaging governed by enhanced hygienic requirements Automated blood application The sensors are designed to avoid flipping and illustrate the cleaning quality of the rinsing process. Automatic application of blood ensures a consistent quantity and distribution of sheep blood. In addition to procuring purchased products, Mythentec takes charge of the manufacture of the indicator ready for sale.

4 HIGHER QUANTITIES, ENHANCED QUALITY Compact racks with 96 sample tubes and caps facilitate automated diagnosis and a variety of lab processes in biotechnology and medical engineering. Mythentec took charge of the existing cap moulds and was tasked with improving the quality of the product and ensuring that this improvement was sustained. The individually marked caps were to be used for sealing glass tubes. The required quality levels were achieved by strategic optimisation of the mould. The new and further improved hot runner moulds now achieve a significantly higher output rate. Mythentec produces a total of six cap types in different colours with 4- or 8-cavity moulds within cycle times of between 7 and 12 seconds. All caps are then conditioned to meet the customer s requirements. The central master computer system continually archives actual injection moulding cycle parameters on the server. Thanks to a high degree of customer satisfaction, Mythentec today acts as a general contractor and takes charge of all subsequent steps. Each cap is laser marked with a unique code for automated sample processing in the lab. Mythentec takes care of the procurement of all purchased parts, assembles complete racks and packages these in units ready for sale. Further processing steps are carried out under enhanced hygienic conditions. The ERP system guarantees complete batch traceability throughout every process. A kanban system ensures short delivery times of one week. Significant cost saving through direct purchasing Further processing under enhanced hygienic conditions Complete batch traceability of all articles Kanban system allows delivery durations of one week Conditioning means that the absorption of water in the plastic over several months is realised within a few hours. The caps are coded by laser to facilitate clear identification of samples in the lab. The glass tubes are fitted with the coded caps and then assembled in a rack with 96 sample tubes.

5 STURDY MATERIAL FOR SKIN CONTACT KITRIS Tennis is an analysis and learning system for coaches and players which functions through the collection of millions of items of playing data by a data tracker worn on the wrist. The Swiss startup was looking for support in re-engineering a product designed in the Netherlands so as to make it suitable for plastics processing. In addition to this, Mythentec was also tasked with the industrialisation and production of the plastic components and the design and commissioning of downstream processes such as ultrasonic welding and laser marking. The most demanding task involved the selection of suitable materials, as the tracker would be in constant contact with the skin during sports activities and may be exposed to a variety of aggressive contact substances (e.g. sun cream, perspiration, body lotion or insect repellent). Mythentec developed a network for the procurement of supplementary housing components and has since been responsible for the direct purchase of these products. Favourable framework conditions and low initial costs for the market launch were achieved through the use of multi-cavity moulds. The commissioning of injection moulds, ultrasonic welding and optimisation were carried out on site of a competent partner s facility in China. All parts are coloured with masterbatches to ensure a rapid reaction to market demands. The scratch-resistant coated display is machined and then decorated by means of a screen printing process. The display, front frame, base plate and main frame are ultrasonically welded by Mythentec, while an adhesive hydrophobic fabric is used to cover the microphone. All trackers bear a consecutive serial number applied by laser marking to aid batch traceability. The display and laser marking are covered by a protective film. This film can be removed without leaving any residue. Commissioning and production monitoring abroad Design and industrialisation of further processing Network development for purchase of systemic parts TPE components ensure pleasant tactile properties and an effective sealing of the housing. The scratchproof display of the front frame is decorated in a screen printing process and ultrasonically welded. Each tracker can be clearly identified, thanks to laser marking.