Injection Molding and Machining Resins for Medical Devices and Components

Successfully matching resins for manufacturing injection molded and machined medical devices and components means reviewing the types of materials available and reviewing the product usage.   Usage considerations include temperature, chemical contact and resistance, applied stresses during use, transparency, opacity, aesthetics, wear resistance, lubricity and sterilization.  

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How to Protect Your Injection Mold Investment

Custom injection molds are critical assets for your plastic components. They represent a major investment. They have to produce consistently precise components reliably.  Regular injection mold maintenance is a simple, effective way to protect your investment and assure product quality, minimize downtime, and reduce total cost of ownership.

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What are the Differences Between ISO 9001:2015 vs 9001:2008 Certification?

Both old and new standards cover essentially the same topics. However, there are some important differences. Some of these are discussed below.

Structure of the ISO 9001 Standard

Perhaps the biggest difference between the old and the new standard is the structure. ISO 9001 2008 had five main sections (4 to 8) and ISO 9001 2015 now has seven (4 to 10). This is because the new edition uses the new Annex SL template. According to ISO, all future management system standards (MSSs) will use this new layout and share the same basic requirements. As a result, all new MSSs will have the same basic look and feel.

A common structure is possible because basic concepts such as management, customer, requirements, policy, procedure, planning, performance, objective, control, monitoring, measurement, auditing, decision making, corrective action, and nonconformity are common on all management system standards. While this will make it easier for organizations to implement multiple standards because they will all share the same basic requirements, it may cause some disruption in the short run as organizations get used to the new structure.

Context of the organization

 Unlike the old standard, the new one expects you to understand your organization’s context before you establish its QMS. When ISO 9001 2015 asks you to understand your organization's context it wants you to consider the external and internal issues that are relevant to its purpose and strategic direction and to think about the influence these issues could have on its QMS and the results it intends to achieve.

This means that you need to understand your organization's external environment, its culture, its values, its performance, and its interested parties before you develop its QMS. Why? Because your QMS will need to be able to manage all of these influences.

 And once you understand all of this, you're expected to use this special insight to help you define the scope of your QMS and the challenges it must deal with. While this will certainly help ensure that organizations develop unique quality management systems that address their own needs and requirements, doing all of this could be quite a challenge for some companies.

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How Plastic Injection Molding Problems are Solved by Mold Fill Simulation

Plastic injection mold fill simulation involves using software to virtually simulate the filling, packing and cooling processes of an injection molded plastic part.  

Simulation software is the key to striking a perfect balance between several variables that affect the molding process. These variables include:

  • Plastic flow rates 
  • Plastic pressure 
  • Cooling rates and timing 
  • Plastic melt temperatures

Any alterations of any kind will influence this complex combination and can permanently affect the molding process and its outcome.   “Accurate mold fill simulations are valuable because they support the same trial-and-error process for discovering the right combination of variables required to produce quality injection molded parts in computer software, which are both faster and less costly”, stated in Prospector article “Overcoming Plastics Injection Molding Problems”.

The end-result is a simulation showing potential problems and allowing for designers to make critical decisions for the part and/or mold design before the mold is ever manufactured.    

The Solutions That Are Accomplished By Plastic Injection Molding Simulation

  1. “Short-Shots” – this is a mold fill simulation that will show areas of the part that will not completely fill with plastic.
  1. The simulation will also show where weld lines develop. Weld lines are areas on the part where two different flow fronts meet - and plastic welds together. These welds can be analyzed to determine if they are structurally sound or not.
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Understand Polyjet 3D Printing Process and Materials

The Polyjet 3D printing process requires jetting multiple layers of a curable liquid polymer directly onto a build tray.

The 3D build preparation software automatically performs the calculations that deliver correct placement of the polymers and support materials from your 3D CAD file.  

The printer will jet and instantly UV-cures tiny droplets of liquid polymer. This means that very fine layers are accumulating on the build tray creating one or several extremely precise 3D parts or models.

Sometimes overhangs and complex shapes will mandate more support material. This will clean internal voids and other finer details that can be missed, or damaged by water-jetting. This approach delivers easily removed material simply by applying water by hand, or by using a solution-bath. This delivers instant handling and use capacity immediately with no curing required.

Extraordinary detail, precision and surface smoothness are easily accomplished. Other benefits of this 3D printing technology include: 

  • The creation of detailed,  smoothly produced 3D printed parts that deliver final-product aesthetics
  • The achievement of extremely complex shapes, intricate details and delicate features of parts
  • Production of accurate molds, fixtures, jigs and other manufacturing tools

3D Printing Materials for Polyet Printing

Digital ABS

All of these materials are capable of creating realistic, precise prototypes and tools that are extremely tough and heat resistant. These materials are used to simulate the standard ABS plastics.  This is perfect for creating functional prototypes including but not limited to manufacturing tools, casings, snap-fit parts for high or low temperature use, mobile phone casings, electrical parts, engine parts and covers - and are completely appropriate for all simulated parts requiring shock absorption and high-impact resistance.

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