Medical Products Made by Injection Molding: A Comprehensive Guide

1. Why Injection Molding for Medical Products?

Injection molding offers several advantages for medical manufacturing:
✔ High Precision – Ensures tight tolerances (±0.02mm) for critical components like syringes.
✔ Sterility & Safety – Compatible with medical-grade plastics that meet FDA, EU MDR, and ISO 10993 standards.
✔ Mass Production – Enables cost-effective manufacturing of millions of units (e.g., disposable labware).
✔ Design Flexibility – Supports complex geometries for ergonomic and functional medical devices.

2. Common Medical Products Made by Injection Molding

Medical Devices & Components

• Syringes (barrels, plungers, caps)

• IV Connectors (Luer locks, drip chambers, valves)

• Surgical Instruments (handles, housings for scalpels/forceps)

• Respiratory Equipment (nebulizer masks, ventilator parts)

Pharmaceutical Packaging

• Medicine Bottles & Caps (child-resistant closures)

• Blister Packs (PVC/PVDC trays for pills)

• Dropper Bottles (for eye/ear drops)

Diagnostic & Labware

• PCR Tubes & Microplates

• Pipette Tips

• Petri Dishes

Wearable & Implantable Parts

• Hearing Aid Shells

• Prosthetic Components

• Dental Surgical Guides

3. Material Selection for Medical Injection Molding

Medical-grade plastics must be:
✅ Biocompatible (non-toxic, non-allergenic)
✅ Sterilizable (resistant to autoclaving, gamma radiation, or EtO gas)
✅ Chemically Resistant (withstands disinfectants & drugs)

Common Materials:

• Polypropylene (PP) – Used in syringes, IV bottles.

• Polycarbonate (PC) – For surgical instruments & transparent housings.

• COC/COP – High-clarity applications like labware.

• PEEK – Implants & high-temperature sterilization.

4. Key Considerations for Medical Injection Molding

• Regulatory Compliance – Suppliers must follow ISO 13485 and FDA 21 CFR Part 820.

• Cleanroom Molding – Prevents contamination for implants/injectables.

• Validation & Testing – Molded parts require rigorous dimensional checks and biocompatibility tests.

Conclusion

Injection molding is the backbone of medical manufacturing, producing everything from disposable consumables to high-precision surgical tools. When sourcing medical injection-molded parts, always:
1️⃣ Choose ISO 13485-certified suppliers
2️⃣ Verify material certifications (USP Class VI, FDA)
3️⃣ Validate mold design for performance & sterility