Like many industries, pharmaceutical manufacturers have strict change management protocols. For this client, for any substituted part to gain approval it must meet defined specifications and determined to be “Fit for Use.” To achieve this approval, the process requires a parts evaluation based on operational environment – temperature, humidity, vibration, stress, etc. – and criticality. Each of those tolerances must be built into the 3D printing plan, to ensure the proper material gets used and the correct print orientation is set. Other factors considered include, the type of material to be used for the product, slice height, or deposit thickness for each layer of material, fill density, and support materials used to hold the developing part in place.
Clear, quantitative guidelines from which to evaluate these conditions and a part’s Fitness for Use are required to avoid inaction simply from fear to change.
OEM relationships add an additional layer of complexity to the 3D printing process. There needs to be clarity between the client and its OEM suppliers regarding intellectual property around spare parts, warranties, and services. Questions to resolve before 3D production can begin, included: Are the parts protected by patents? Are the parts only available from the OEM supplier? Are they considered a commodity? Can they be fabricated? It is also important to document the impact on equipment warranties and services.
Some OEMs are embracing 3D printing as an alternative source for specific spares. Appropriate file types are often sold to the end user for printing, some with licences limiting the number of printed parts. Others will share the CAD files, handing off printing responsibility to the end user.
With all planning steps aligned and client agreement, RS Integrated Supply launched the project with an audit of the company’s inventory. The results showed more than 12,000 items in inventory. More than 9,000 of those spare parts were inactive, with no purchase activity in the previous 24 months. Of the remaining 3,000+ parts, more than 150 were determined eligible for 3D printing once any required digitalisation was complete.
Digitalisation involves creating an executable file of the part. It involves scanning the part to generate a point cloud image. That is followed by modelling the part to create the proper print format file, which directs the printing operation. During the modelling phase, scan imperfections are removed, and any requested design changes are made.