Quality injection molding in healthcare manufacturing elevates plastic components across multiple vectors, including functionality, equipment longevity, cost savings, and more. Delivering the intricacy and precision required for the medical injection molding market necessitates specialized protocols and production processes.
A manufacturer that specializes in medical plastics understands how to leverage those protocols to achieve exceptional quality, minimize risk, and ensure all components meet regulatory standards. By asking the right questions, OEM decision-makers can uncover valuable information about a potential partner’s healthcare experience and ability to deliver consistent, high-performing parts with every production run.
In this post, we’ve compiled 8 essential questions to ask, with insights on which answers indicate meaningful healthcare knowledge and expertise.
What ISO standards and certifications does your company follow?
The International Organization for Standardization (ISO) is a non-governmental body that outlines quality management systems (QMS) across industries to ensure safe, reliable products enter the global market. ISO guidelines are designed to align closely with quality standards in 172 countries, including most U.S. FDA requirements.
Look for the following certifications, which indicate the manufacturer has made a significant commitment to quality assurance:
ISO 13485
Manufacturers specializing in medical devices should be certified under ISO 13485, which lays out strict guidelines for safety and quality processes.
ISO 9001
The ISO 9001 standard outlines processes and procedures that emphasize customer satisfaction, efficiency, and overall quality assurance that lead to consistency and continuous improvement.
Verifying ISO compliance
Decision-makers can verify a potential manufacturing partner’s ISO certification via the International Accreditation Foundation’s free CertSearch tool. But it’s also crucial to confirm the manufacturer actually follows the quality protocols outlined in these certifications. The best way to do that is to request a facility tour and observe a production run.
Good manufacturing practices
For greater assurance that the contract manufacturer’s parts will align with federal requirements, seek out partners with FDA-registered facilities. Registered facilities are routinely inspected to ensure the manufacturer follows current good manufacturing practice (CGMP) as outlined in the federal regulation 21 CFR 820.
What quality controls do you use for products currently in production?
A specialty manufacturer understands that robust quality control (QC) processes are essential for healthcare products, as inferior parts can put a patient’s health or life at risk. Specialized quality measures include startup testing to ensure the process begins correctly, in-process checks that monitor various production stages, and final inspections to ensure each batch meets specifications.
Examples of effective quality controls include:
95/5 analysis through PQ controls: controls designed to process new molds and production parts. The manufacturer should document these processes and share the results so the OEM can review and sign off on each step.
Dimensional checks: in-process tools that use calipers or measuring machines to verify that parts meet precise dimensions.
Visual inspections: human or robotics can perform in-process visual checks for defects like scratches, dents, or color inconsistencies, or examine mated parts to confirm fit and function.
Another vital control is using reference parts, says Justin Heileman, Chief Strategy Officer at Elite Precision Plastics. These include “golden samples,” or products set aside from the first good production run that represent the ideal part and are used for comparison during quality checks, and “last-run parts,” kept from the most recent production run to serve as a baseline for future production runs.
Beyond the basics
In some circumstances, medical injection molding companies may incorporate additional quality controls, beyond those outlined in the ISO standards. “You can always be more stringent, more detailed on the controls,” explains Heileman. “Depending on the needs of the customer, we may add controls to measure certain CTQs, or critical-to-quality dimensions at startup and in processing that go more in depth.”
How are incoming materials inspected?
To prevent quality issues from the start, the manufacturer should verify that incoming materials are accompanied by a Certificate of Conformity (CoC), typically issued by a government or 3rd-party inspector. The CoC includes the batch number, material composition, and relevant ISO or FDA standards information. A contract manufacturer may also perform visual, melt flow, or moisture content analysis on incoming resins.
Do you use virgin resin or regrind?
Manufacturers can choose to use virgin resin or regrind materials. “Regrind” refers to previously used plastic from scrap or production waste that has been reground into resin pellets). Virgin resin is raw plastic that has never been processed. Its molecular structure and physical properties are intact and uniform, so it’s highly predictable in performance.
For non-critical applications, regrind can be a cost-effective and environmentally friendly solution. However, the regrind's molecular structure has been altered, so it can behave inconsistently, resulting in inferior properties. Therefore, virgin resins are essential to achieve the quality, precision, and high performance necessary in healthcare manufacturing.
What is your process validation method for new molds and parts?
Process validation ensures that new molds can consistently produce quality parts. One of the most effective validation methods for healthcare parts involves the following steps:
Installation qualification (IQ): verification of all equipment and systems to ensure correct installation according to manufacturer specifications.
Operational qualification (OQ): testing how the mold and equipment function at various temperatures, pressures, and injection speeds to verify it consistently meets the requirements of the new part.
Performance qualification (PQ): conducting extended production runs under normal operating conditions and performing quality checks on the produced parts.
The PQ phase includes FAI dimensional, visual, and fit/function verification for further assurance that the mold and machine will deliver consistent, high-quality production.
Is your equipment capable of meeting tight tolerances?
Dimensional precision is paramount in healthcare manufacturing. Not all injection molding machines are capable of consistently meeting high-tolerance specifications. It's essential to discuss the exact tolerance needs of plastic parts with potential partners and to learn as much as possible about the equipment with which they’ll be producing new parts.
In general, all-electric injection molding machines do well with holding tighter tolerances across production cycles. These machines have more control over each axis of movement and faster response times, and they aren’t affected by fluid dynamics, which can impede precision on hydraulic equipment.
Do you use single or multiple machines to produce a specific product?
Settings can differ across injection molding machines and even subtle differences between identical models can potentially cause variations in part quality. In healthcare manufacturing, using a single, dedicated machine for each product across all production runs minimizes the risk of defects. If the mold must be moved to a different machine, the manufacturer should be prepared to requalify the production process on the new equipment to ensure continuous quality.
How do you handle non-conforming parts?
Non-conforming parts are inevitable in any production process, but how these occurrences are handled can impact overall product reliability and safety.
In the event of non-conformance, ideally, the manufacturer should:
● Conduct a root cause investigation to determine whether the defect is related to materials, equipment, human error, or another reason.
● Implement corrective actions, such as process improvements, machine adjustments, staff retraining, or enhanced quality checks.
● Notify the OEM partner immediately to facilitate timely decision-making before the issue impacts downstream processes or product launches.
Manufacturer transparency also ensures OEMs can provide clear information to their own customers if needed.
Asking these questions helps identify a medical injection molding manufacturer that can meet stringent standards while prioritizing precision and consistency. Want to learn more about the medical injection molding process and the experience required to deliver successful products? Get in touch.