When any company takes on medical molding as part of their service options, they are committing themselves to making the highest possible quality of parts. However, it isn’t just about making quality parts once, it is about repeating the process with every part to create components that are highly repeatable, have a high degree of accuracy, and that are also top quality.
With medical molding at the heart of the validation process for the device or equipment as a whole, everything has to perfect and within the required range of repeatability and tolerances and set forth in the applicable standards.
Often with medical molding the biggest complication for the client, as well as the molding company, is to determine which regulations or standards the part or component has to be designed to meet.
Typically a company or a designer will set the tolerances for the production of medical molding components. The molding company, and their experts and engineers, may be the ones that actually determine what standards, or which regulations, meet the threshold of a “high degree of assurance” in the consistency of the product.
Testing for Compliance
Throughout the procedure and at various stages it will be important to test and inspect the components. When this is done as part of the initial medical molding validation and also the prototype development, early problems can be quickly identified, addressed and corrected.
In some cases, the assurance of consistency with the medical molding process is due to environmental factors that may impact the production. This could include changes in the humidity of the room, temperature issues, minor adjustments to a mold or even slight variations in the setting on a particular machine.
Another factor can include changing machines, operator variables or even slight changes in the composition of the resin. This last issue can often occur from the supplier, and it will be out of the control of the company offering the molding services.
Working with the Best
When validation is going to be a component of the process, as is found with medical molding jobs, working with a company with experience, expertise and a proven track record in highly efficient, repeatable and consistent process is always the most important factor to consider.
These companies providing these expert levels of medical molding services use only well-trained, professional and experienced technicians to limit any variations that may impact the mold injection validation process.