American Plastics is an FDA-registered plastic injection molding company specializing in injection molding for regulated products. Our ISO-9001:2015 contract manufacturing facility produces high-quality plastic injection molding components for a wide range of (non-sterile) medical applications.
We support manufacturers operating in FDA-regulated industries, even if final device validation and sterilization occur downstream. That wealth of experience extends to the engineering-grade resins most commonly specified for regulated medical injection molding.
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Injection Molding for FDA-Regulated Products
Plastic injection molding for medical devices is projected to grow from $24.6 billion in 2023 to $37.8 billion by 2033. Manufacturers entering that space need injection molders already operating inside the FDA and ISO frameworks.
At American Plastics, our ISO 9001-certified facility operates under FDA registration to manufacture components entering regulated supply chains. We maintain the material traceability and process documentation required for downstream compliance audits from the start of each project.
Thirteen presses ranging from 55 to 400 tons handle scientific, traditional, and insert-over molding for high-volume and blanket order production. Engineers review part geometry before tooling fabrication begins to prevent dimensional errors that would compromise regulatory compliance.
Our Assembly, Packaging, and Shipping Capabilities
We offer several post-molding processes on-site to eliminate additional vendors from your supply chain. This allows parts to move from molding to final packaging without the transition time required when coordinating separate facilities.
Products requiring measured dosages get filled on-site according to regulated requirements. Finished components ship directly to your distribution centers or downstream facilities.
High-Performance Thermoplastic Resins
Material selection for injection molding for healthcare and laboratory products affects regulatory compliance and product performance in FDA-regulated applications. We process a wide range of engineering-grade resins chosen for their thermal stability, chemical resistance, and mechanical properties.
- Medical-grade polypropylene provides chemical resistance and flexibility for repeated use without degradation. We process it in formulations that meet FDA contact requirements.
- Polycarbonate combines impact resistance with optical clarity where transparency is required. It’s ideal for maintaining dimensional stability across temperature variations.
- PVC maintains chemical stability when exposed to various fluids and cleaning agents. We mold it in both rigid and flexible formulations.
- PEEK withstands extreme temperatures and harsh chemical environments without degrading. We process it for parts requiring repeated sterilization.
- Acetal delivers low friction and high stiffness for precision parts requiring tight tolerances. Our team molds it to maintain dimensional accuracy during mechanical stress.
Injection Mold Design & Tooling
Our technical team partners with regional CNC fabricators to design and build tooling engineered for your exact specifications and production volume requirements. These molds are built to maintain dimensional accuracy across tens of thousands of cycles without degradation or drift.
We support tooling development from initial prototype stages through full-scale production runs. Preventive maintenance programs keep your molds performing consistently throughout the entire product lifecycle.
Our Quality Control Process
Plastic injection molding for medical devices is growing at a 4.4% CAGR through 2033. Suppliers without existing documentation and traceability infrastructure will struggle to keep pace with that compliance burden.
FDA registration requires full traceability and process documentation throughout production. Our ISO 9001-certified quality control department provides both through a three-tiered inspection system. Inspectors verify dimensions, structural integrity, and material consistency from first article approval through final shipment.
Tight-tolerance components are measured using a Matrix Series MicroVu coordinate measuring machine for precise X, Y, and Z axis verification. Heat reversion, pressure burst, and crush testing validate material performance under operating conditions. Both destructive and non-destructive protocols confirm components meet regulated product requirements.
Frequently Asked Questions
Q: Can you accept our existing molds for FDA-regulated production?
A: Yes, we can receive transfer molds that already exist. Transferred tooling undergoes validation before production begins. We can also design and make new tooling for new and existing products.
Q: What press capabilities do you have for larger regulated components?
A: Our presses accommodate tie bar spacing as wide as 36 inches with shot sizes up to 54 ounces in weight. This handles larger medical and laboratory components.
Q: Do you provide first article inspection for regulatory approval?
A: Our team generates first article parts and submits them with a comprehensive first article inspection report to the customer for review and approval. The approved report serves as the dimensional benchmark for future production runs.
Q: Do you handle blanket orders for FDA-regulated components?
A: Our facility can handle high-volume production requests, blanket orders, and repeat orders, including those that require supplemental services like assembly, filling, labeling, and packaging operations.
Q: Can you mold Santoprene for flexible medical components?
A: We process Santoprene for flexible components requiring rubber-like performance with the processing advantages of thermoplastic materials.
Partner With American Plastics for Industry-Leading Injection Molding Services
American Plastics provides FDA-registered contract manufacturing for components entering regulated supply chains. Our turnkey process eliminates vendor coordination by handling tooling, molding, assembly, and packaging under one ISO 9001-certified facility.
Manufacturers requiring consistent documentation and material traceability partner with us for long-term production programs. Contact our team to discuss your next regulated component project.
