The production process of medical marker pens combines specialized material selection, precision manufacturing processes, and strict quality control to ensure their safety and reliability in medical environments.
一. Material selection
Ink composition:
Non toxic formula: must comply with medical grade standards (such as ISO 13485, FDA certification), and not contain harmful substances such as heavy metals and phthalates.
Quick drying: usually alcohol based (such as isopropanol) or water-based ink, can quickly dry and adhere to the skin or instrument surface.
Waterproof/alcohol resistant: Ensure that the markings are not easily erased during disinfection or surgical procedures.
Color stability: Commonly used easily recognizable colors such as purple and blue, some containing fluorescent agents for special scenarios.
Pen design:
Fiber pen tip: High density fibers ensure even ink leakage and prevent dripping.
Ball shaped pen tip: Some parts use stainless steel or ceramic ball beads to ensure smoothness.
Pen holder material: medical grade plastic (such as polypropylene PP), resistant to gamma rays or ethylene oxide sterilization.
2. Production process
Ink preparation:
Mix solvents, dyes, stabilizers, etc. in a sterile environment and filter to remove impurities.
Ink needs to undergo biocompatibility testing (such as skin irritation testing).
Pen head assembly:
Fiber pen tip: cut into a specific shape and fixed by ultrasonic welding.
Ball shaped pen tip: Precision embedded ball to ensure smooth rotation.
Pen holder molding:
The injection molding process for producing pen holders may add anti slip patterns or chemical corrosion resistant coatings.
Filling and sealing:
Automated equipment injects ink into the ink storage tube, and the pen head and holder are assembled and laser sealed to prevent contamination.
Sterilization treatment (some products):
Use ethylene oxide (EO) or irradiation sterilization to ensure sterility.
3. Quality control
Performance testing:
Writing fluency, drying time, adhesion (simulated wiping or liquid contact).
Pen durability test (such as continuous line length).
Security certification:
Biocompatibility (ISO 10993), cytotoxicity testing.
Partial compliance with environmental standards such as RoHS and REACH is required.
4. Packaging and labeling
Aseptic packaging: Single independent packaging, labeled with sterilization expiration date.