Medical Injection Molding: Understanding the Three Levels of Production
The plastic injection molding industry serves a wide range of enterprises, each with different requirements for materials, certifications, and standards. Medical injection molding, however, operates at a different level entirely. Companies specializing in this production must deliver exceptionally tight tolerances, use materials that meet rigorous standards, and follow specialized processes that go beyond standard plastic injection molding practices.
Medical plastic manufacturing also isn’t a single category. At Camcar Plastics, we like to divide it into three branches: non-cleanroom, cleanroom, and implantable/bodily contact medical products. Currently, our company specializes in non-cleanroom medical devices, producing items like instrument trays and tubing connectors. As we continue to expand our capabilities through new certifications and developing new manufacturing environments, one of our long-term goals is to offer more advanced medical injection molding services to the constantly evolving healthcare industry.
In this blog, we’ll explore what sets medical injecting molding apart from standard plastic parts manufacturing. We’ll focus on the three branches of medical injection molding, including factors like regulatory compliance, quality standards, sterilization compatibility, and material selection.
The Three Branches of Medical Injection Molding
1. Non-Cleanroom Medical Products
Non-cleanroom medical injection molding products are items that are used during medical procedures and in equipment, but don't require the intense, sterile manufacturing environments of other medical components. These parts don't come into direct contact with patients, but they still require important quality standards to ensure reliable performance in serious medical spaces.
Common applications include instrument trays and organizers, tubing connectors and fittings, equipment housings, handles for medical tools, and storage containers for non-sterile supplies.
While these products don't require cleanroom manufacturing, they still demand precision and quality control. At Camcar Plastics, we currently produce non-cleanroom medical components using durable, medical-grade materials like polypropylene (PP) and ABS (Acrylonitrile Butadiene Styrene), chosen for their strength, chemical resistance, and ability to withstand repeated use and cleaning procedures.
Our ISO 9001 certification and NAICS 339113 classification for Surgical Appliance and Supplies Manufacturing showcase our capabilities to produce these items, as well as our commitment to quality production and regulatory compliance. Whether it's a tray that securely supports surgical instruments or tubing connectors that create reliable seals, tolerances must still be tight enough to ensure proper function.
2. Cleanroom Medical Products
Cleanroom medical products take medical manufacturing precision to the next level. These components typically include items like syringes, IV components, diagnostic test tubes, and surgical instruments. They also must be produced in controlled ISO Class 7 or Class 8 cleanroom environments to prevent the risk of contamination.
Beyond the controlled environment, cleanroom medical manufacturing demands complete material traceability with full documentation from raw material sourcing to final production. This oversight is mandated by FDA regulations under 21 CFR Part 820 and Good Manufacturing Practices (GMP).
Materials must also meet USP Class VI biocompatibility standards, ensuring they won't cause toxic, allergic, or inflammatory reactions when in contact with human tissue. The tolerances required are often as tight as ±0.001 inches because these parts must function properly to ensure patient safety.
Manufacturers in this category typically hold an ISO 13485 certification, demonstrating the expertise and regulatory compliance needed to produce these medical-grade components.
3. Implantable and Bodily Contact Devices
The highest level of medical injection molding involves parts that will be implanted in the human body or come into direct contact with internal tissues. This includes catheter components, surgical implants, and internal medical devices (like pacemakers or joint replacements).
Sterilization compatibility and biocompatibility is built into every part of this process, beginning at the design phase and material selection. The parts must withstand autoclaving, gamma radiation, or ethylene oxide sterilization without warping or degrading. Parts must also maintain their integrity through repeated sterilization cycles.
There is absolutely no room for error when it comes to this type of medical plastic parts manufacturing. Rigorous quality control, continuous monitoring, and documentation of every element in the production process are non-negotiable at this level.
Choosing the Right Manufacturing Partner
Understanding these three branches is essential when selecting a manufacturing partner. Non-cleanroom products require quality manufacturing practices and ISO 9001 certification. Cleanroom products demand controlled environments and ISO 13485 certification, and implantable devices need the highest level of biocompatibility testing and sterilization processes.
At Camcar Plastics, our specialization in non-cleanroom medical products means we deliver precision-molded components that healthcare facilities rely on daily. Our certifications and commitment to quality ensure that every part we produce meets the exact standards required in specific medical environments. As we continue to invest in our capabilities, we're eager to position ourselves to serve a broader range of medical manufacturing needs in the future.
Whether you need non-cleanroom components or more advanced medical parts, choosing a manufacturer with the right expertise and certifications for your specific needs is essential.
To learn more about our medical injection molding services, fill out our contact form.
