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1. Formulation Design
1.Resin: Medical‑grade PVC resin (K‑value 70–80).
2.Plasticizers:
(1) Conventional general plasticizer: Di(2‑ethylhexyl) phthalate (DEHP);
(2) New environmentally friendly plasticizers: Di(2‑ethylhexyl) terephthalate (DOTP), Trioctyl trimellitate (TOTM), Diisononyl cyclohexane‑1,2‑dicarboxylate (DINCH).
3.Epoxidized soybean oil (ESO).
4.Stabilizer: Calcium‑zinc (Ca/Zn).
5.Lubricant: Oxidized polyethylene wax.
2. Production Process Control
1.PLC-controlled automatic metering feeding with a deviation of ≤1%.
2.High-speed mixing temperature: 120 ℃–130 ℃, duration: 10 min.
3.Powder material is cooled by external water cooling to 70–80 ℃.
4.Extrusion is carried out using a two‑stage extrusion unit at 125–130 ℃.
5.Pellet hot‑cutting is performed with Class 100,000 clean air conveying.
6.The cooling workshop is a Class 100,000 cleanroom.
7.Automatic bag filling and robotic palletizing for packaging.
3. Physical, Chemical, and Biological Properties
1. Physical Properties:
(1) Hardness meets the requirements for different regional environmental conditions.
(2) Tensile strength: ≥13 MPa.
(3) Elongation at break: ≥250%.
(4) Thermal stability time (oil bath at 180 ℃): ≥60 min.
2. Chemical Properties:
(1) Reducing substances: ≤1.3 mL.
(2) pH change: ≤1.
(3) Zinc content: ≤0.4.
(4) Total heavy metals: ≤1.
3. Biological Properties:
Complies with the biological evaluation requirements of ISO 10993‑1 and the standard
GB/T 15593‑2020.
4. Packaging, Storage, and Shelf Life
1.25 kg/bag: outer low‑plastic composite bag + inner double‑layer PE bags; 800 kg/bag: outer PP woven bag + inner single‑layer PE bag.
2.Store in a ventilated, moisture‑proof indoor environment at room temperature, free from contamination and thermal radiation.
3.Shelf life: 18 months from the date of pelletizing.
5. 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.
