Ultra Fine Nano Calcium Carbonate Powder Used for Medical Grade PVC Material

Overview

Chemically formulated as CaCO₃ with trace impurities (Fe <5ppm, Pb <2ppm, As <1ppm), this white powder offers exceptional biocompatibility and processability, making it ideal for manufacturing medical-grade polyvinyl chloride (PVC) materials used in healthcare products. The nano-scale particle size provides superior reinforcement and surface area (50–80 m²/g), enhancing the mechanical and optical properties of PVC without compromising regulatory compliance.

Characteristics

Nano-Scale Performance:

High Surface Area: 50–80 m²/g surface area improves interfacial bonding with PVC resins, increasing impact strength by 25% and reducing brittleness in flexible PVC formulations (e.g., IV bags, blood tubing).

Uniform Particle Distribution: Laser diffraction confirms ≤10% particle size variation (CV ≤10%), ensuring homogeneous dispersion and minimizing defects in medical devices.

Medical-Grade Purity:

Stringent Impurity Control: Meets USP <467> and EP 2.4.23 standards for heavy metals, with microbial limits (Total Plate Count <100 CFU/g, absence of E. coli and Salmonella).

Non-Toxic Additive: Free from phthalates, latex, and other harmful substances, compliant with FDA 21 CFR Part 178.3297 for indirect food/medical contact applications.

Process Optimization:

Surface Modification: Silane-treated (3% KH-550) to improve compatibility with PVC polymers, reducing plasticizer migration (DEHP loss -15%) and enhancing extrusion efficiency (output +10%).

Optical Clarity: Nano particles (≤100nm) do not scatter visible light, maintaining PVC transparency (haze ≤5%) for medical packaging like reagent bottles and diagnostic device casings.

Application

Medical-Grade PVC Products:

Infusion Systems: Reinforces PVC in IV bags and tubing, improving burst pressure (from 300kPa to 375kPa) while maintaining flexibility for kink resistance.

Blood Storage Equipment: Used in blood bags and transfusion sets, where its biocompatibility ensures no adverse reactions with blood components (hemolysis rate <0.1%).

Pharmaceutical Packaging:

Blister Packs: Enhances rigidity of PVC-PVDC composite films, reducing package breakage during sterilization (e-beam or gamma irradiation) and improving drug shelf life (moisture permeability -20%).

Syringe Components: Improves dimensional stability of PVC plungers, ensuring smooth operation (force variation ≤5N) in automated syringe filling lines.

Dental and Surgical Materials:

Denture Bases: Added to acrylic resin blends to increase surface hardness (Vickers hardness +15%) and resistance to oral bacteria adhesion (biofilm formation -30%).

Surgical Gloves: Reinforces PVC-based gloves, reducing puncture rates (from 0.5% to 0.3% in ASTM D6319 testing) while maintaining tactile sensitivity.

Regulatory Compliance:

ISO 10993 Certification: Tested for cytotoxicity (MTT assay ≥90% cell viability), sensitization (maximal assay score 0), and irritation (Draize score 0), meeting global medical device standards (FDA 510(k), CE MDR Class I/II).