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When seeking a partner for plastic injection molding, the central question should be: Is this manufacturer capable of producing the part or product you desire?

If not, you might need to extend your search.

There are some specific ways to understand — before and after getting an estimate — whether a particular partner has the capacity you require.

Determining Capability of Injection Molder

Does the partner have the production capabilities for your project? Here are a few basic considerations.

The partner should have

  • The equipment needed to perform the job, for example – horizontal and vertical injection molding machines
  • Facilities that are modern and well maintained
  • A plant designed for efficient workflow with flexible manufacturing systems
  • Capable of performing process monitoring, scientific injection molding, and decoupled molding to ensure the best manufacturing outcomes
  • Demonstrated success in designing and fabricating injection molds
  • Integrates automation, depending on your project needs
  • Have the quality certifications and registrations required for your product

And the partner should be a financially healthy entity with evidence of success in completing projects on time and within projected budgets.

What are some of the other considerations when evaluating an injection molding partner?

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For example, a pharmaceutical company often has specific criteria for manufacturing molded parts for medical devices. They may require

  • Molded parts that are manufactured in a certified ISO cleanroom
  • Certification for manufacturing to meet the standard for ISO 13845 Medical Devices
  • US-based manufacturing to reduce transportation delays and shipping costs
  • In-house design to address design and cost challenges

Several systems are in place to evaluate and document the quality of products. It's worth taking note of which standards the potential partner is meeting.

A Quick Guide to Quality Management System: Standards and Certifications

With any project, it's important to understand the partner's abilities to assess and guarantee the quality of the product. The partner should have risk management tools and processes that allow for a successful manufacturing outcome. 

The Quality Management System is a program used to monitor, evaluate, and document a project's various aspects to ensure it meets all the standards for quality. What are some of the elements of a quality management system?

  • FDA registration ensures the injection molding partner complies with the rules established under FDA quality system regulation as established under the 21 code of Federal Regulation (CFR) Part 820 (Medical Devices). Certification and government compliance ensure the highest quality processes.
  • ISO 13845 certification is a manufacturing certification in line with the Food and Drug Administration's standards for regulating medical devices.
  • Process validation uses objective evidence to establish that a process consistently produces a product that meets predetermined specifications; this helps to diminish the risk of product failure.
  • Product/Process Failure Mode and Effect Analysis (PFMEA) is a quality engineering tool used to quantify and evaluate the process variables used in the injection molding process. It is another way of evaluating quality and reducing the risk of product defects.
  • RPN is used to calculate the relative risk with the defects. This must be calculated for the entire process or design. After the RPN is calculated, the failure modes with the highest RPN are assigned to the highest priority, and corrective action is considered.
  • Mold Fill Simulation Utilization software simulates the filling, packing, and cooling of a molded plastic part. Simulation of the various stages of mold filling sparks proactive communication and decisions in the design phase, resulting in a successful tool launch into production.
  • Project Management Office. A Project Management Office ensures that the project remains within budget, keeps the project on schedule, and complies with all the project needs and regulatory requirements.

A Long-term Partnership

When determining a potential partner's capacity, you are looking for someone who can step up and solve problems with you.

Some partners, like Crescent Industries, have evolved to offer post-processing operations to manage the complete supply chain. They can provide design, mold build, molding, secondary operations, and inventory management. In today's environment of supply chain problems, a full-service injection molder can save time, money, and headaches.

Finally, choosing a partner is not simply choosing the lowest number from a series of estimates. A buyer's guide can help you narrow your search and select a partner that is right for you and your project.


Topics: plastic injection molding, medical device molding, purchasing injection molds