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When choosing a developer of machinery, what do you pay attention to? Of course, it is important for the developers to comply with the quality requirements for the medical industry. There are many regulations to guarantee the quality of the machine and thus the products, of which machine designers and builders’ knowledge should always be up to date.
Furthermore, there are three factors that can affect the quality of the machine and your product: The human factor, the product specifications and design and the design of the machine. Machine developers should be able to take these factors into account to guarantee the best outcome.
The human factor has a big influence on the quality of the end products. The more handling is required, the bigger the chance of human error. When more people are operating machines, it automatically leaves more room for mistakes. Production steps can be overlooked and the chance of contamination increases. When machines leave room for the adaptation of processes, people will - with the best intentions - try and optimize the process and digress from procedures, resulting in deviations in the end product. The human factor should therefore always be considered in the design and construction of machines.
The quality of the outcome is also affected by product specifications and product and packaging design. Allowed tolerances of components influence the required precision of the process. When the range of allowed deviation of products is very small, the risk of insufficient quality is higher. To nonetheless guarantee the quality of a product, close attention must be paid to both controlling and logging the processes and outcome.
The experience of developers with the quality of materials and with designing also influence the quality of the machines. When machines are built robustly and are designed based on the production processes, fewer errors and less downtime will occur. The design of the machine can also ensure prevention of contamination. For example, by not placing an actuator above the product level, particles are prevented from falling into the product. GTE-engineering ensures, in line with GMP (Good Manufacturing Practices), that actuators are placed on or below the product level as much as possible.
These three factors cannot be captured in rules and laws. The expertise and experience of the machine manufacturer are essential to the successful design of machinery. In the design of the best machines, a change in thinking is required to reach the ultimate result.
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