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1. Formulation Design
1.Resin: Medical‑grade PVC resin (K‑value 65–85).
2.Plasticizer system (two categories)
(1) Phthalate plasticizer (DEHP)
(2) Non‑phthalate plasticizers (DOTP, DINCH, TOTM, etc.)
3.Heat stabilizer: Calcium‑zinc (Ca/Zn) system, free from heavy metal release, compliant with REACH regulations.
4.Lubricants:
(1) Stearate ester
(2) Oxidized polyethylene wax
5.Functional additives (colorants) added according to specific application requirements.
2. Production Process Control
1.Raw material batching adopts PLC automatic control with high accuracy (≤1‰).
2.Mixing and kneading at 125 ℃–135 ℃ for approximately 12 minutes.
3.Extrusion is carried out using a twin-screw extrusion unit; shear plasticizing temperature is 125 ℃–135 ℃.
4.Cooling is performed in a Class 100,000 cleanroom with air cooling to ensure no external contamination.
3. Quality Control Points
1.Process parameters are recorded once per hour, and patrol inspections are conducted twice per hour.
2.Finished product sample inspection is performed once per hour.
3.A full physical and chemical performance test is conducted for each batch before release.
4. Core Physical, Chemical, and Biological Properties
1. Physical Properties
(1) Hardness: 55–85 Shore A (±3)
(2) Tensile strength: 11–15 MPa
(3) Elongation at break: 200–400%
(4) Thermal stability yellowing time (oil bath at 180 ℃): ≥60 min
2. Chemical Properties
(1) Reducing substances: ≤1.3 mL
(2) pH change: ≤1
(3) Zinc (Zn) content: ≤0.4
(4) Total heavy metals: ≤1
3. Biocompatibility
Pyrogen, hemolysis, sensitization, cytotoxicity, acute systemic toxicity, and intracutaneous irritation meet the requirements of ISO 10993‑1 and GB/T 15593‑2020.
5. Packaging and Storage
• 25 kg/bag: outer low‑plastic composite bag, inner double‑layer PE bag.
• 800 kg/bag: outer PP woven bag, inner single‑layer PE bag.
• Store in a ventilated, moisture‑proof environment free from heat radiation and contaminants.
• Shelf life: 18 months from the date of extrusion.
6. Services and Support
2.E‑mail: kegfzxz@126.com / kechemxz@126.com
3.Tel: 400‑008‑5899; 0086‑514‑84634665 / 84661852
4.Fax: 0086‑514‑84661500
5.ISO 13485 quality management system certified.
6.MSDS provided upon request for product technology.
7.24‑hour response to customer inquiries.
