1. Raw material preparation
Base material: commonly used non-woven fabrics, PE (polyethylene), PU (polyurethane), cotton cloth or breathable film, etc. Different materials determine the air permeability, flexibility and strength of the tape.
Adhesive: mostly acrylic, silicone or natural rubber (desensitization treatment is required), which must be hypoallergenic, mildly sticky, and easy to tear without leaving residual glue.
Auxiliary materials: release paper (anti-sticking backing paper), coating agent (to enhance adhesion), sterilizer (such as ethylene oxide).
2. Coating process
Base material treatment: The base material is cleaned and dried, and may be corona treated to improve the adhesion of the adhesive.
Gluing: The adhesive is evenly applied to the base material by scraper, roller coating or spraying, and the thickness is precisely controlled (usually 0.02~0.1mm).
Drying: The base material after glue coating passes through the drying oven to remove the solvent (if solvent-based glue is used), and the temperature is controlled at 50~80℃ to avoid material denaturation.
3. Composite and slitting
Composite release paper: The coated surface is covered with release paper to prevent adhesion and facilitate subsequent cutting.
Slitting: The large roll material is slit according to the required width (such as 1cm, 2.5cm, etc.), and the edges must be smooth and free of burrs.
4. Sterilization
Ethylene oxide (EO) sterilization: A common method, suitable for materials that are not resistant to high temperatures, and ventilation is required to analyze residual gases.
Gamma ray sterilization: Used for highly sensitive products, no chemical residues.
Moist heat sterilization: A few high-temperature resistant materials can be used, but they are rare.
5. Packaging and quality inspection
Roll packaging: The automatic roll splitter cuts the tape into small rolls, puts them into sterile bags or boxes, and marks the sterilization validity period.
Quality inspection items:
Viscosity test: Ensure that the peel strength is moderate (such as 0.5~1.5N/cm²).
Biocompatibility: Pass skin irritation test and cytotoxicity test.
Sterility test: in accordance with ISO 11737.
6. Special types of tapes
Waterproof tape: The base material is PE or PU, and the hydrophobic adhesive is coated.
Breathable tape: Use porous non-woven fabric or perforated film.
Elastic tape: Add elastic fiber (such as spandex) and it is suitable for joints.
Key quality control points
Adhesive formula: Avoid latex or irritating ingredients.
Production environment: Some links need to be carried out in a clean workshop (such as ISO Class 8).
Sterilization verification: Ensure that each batch reaches the sterility assurance level (SAL≤10⁻⁶).
The production of medical tapes must comply with relevant medical device regulations (such as FDA 21 CFR, ISO 13485) to ensure safe and reliable clinical use.