Vertellus Citroflex™ citric acid esters are natural raw materials derived from the fermentation of corn. Medical-grade plastic applications require performance characteristics that endure repeat sterilization, corrosion, and temperature resistance and must maintain flexibility, softness, and safety when interacting with patients and medical providers. Medical tubing positioned internally must be soft and flexible for optimum patient treatment and comfort.

Various plastic resins used in medical devices, such as polyvinyl chloride (PVC), are inherently rigid and structured. Plasticizers are necessary to increase flexibility and softness for rigid resins like PVC. Citroflex™ B-6 provides a clean toxicological profile and a great alternative plasticizer to Diethylhexyl Phthalate (DEHP) for medical plastic devices. Citroflex™ B-6 citrate esters are specially formulated from natural citric acid raw material.

 

Phthalates are chemicals developed for various uses in plastics, solvents, and personal care products. However, growing concerns and studies have required manufacturers to transition away from phthalates towards products that are phthalate-free. Citroflex ™ B-6 is a completely phthalate-free plasticizer that can ensure compliance with both European and North American regulatory standards.

 

Vertellus Citroflex™ B-6 Benefits For Medical Devices

  • Phthalate-free plasticizer solution
  • Approved by European Pharmacopeia
  • Proved, field-tested solution for 20+ years
  • Excellent low-temperature flexibility
  • Clean toxicological profile

 

Outstanding Replacement to DEHP 

Citroflex™ B-6 is an easy drop-in DEHP-replacement solution for PVC compounders. Allowing manufacturers to maintain compliance with regulatory restrictions while improving performance and providing an easy formulation replacement. The benefits of utilizing Citroflex™ B-6 as a PVC plasticizer in comparison to DEHP are:

  • Similar or slightly improved physical properties
  • Reduced brittle point temperature
  • Significantly less volatile loss
  • Lower soapy water extraction

 

Performance Comparison
Citroflex™ B-6 DEHP
Hardness, Shore A 81 79
Tensile Strength, psi 2924 2748
Ultimate Elongation, % 427 395
100% Modulus, psi 1362 1368
Brittle Point, °C -33.5 -24.5
Volatile Loss (Air), % 1.7 4.8
Volatile Loss (A/C), % 1.4 3.4
Soapy Water Extraction, % 2.2 2.7

    Representative data for Medical Grade PVC films prepared using 50 phr plasticizer, 2.5 phr stabilizer, and 0.25 phr lubricant.


 

Excellent Low-Temperature Benefits

Citroflex™ B-6 sustains lower G’ modulus for PVC films plasticized at sub-freezing temperatures. This allows medical devices such as blood bags to have increased flexibility at extreme temperatures to preserve the blood specimen for future use. 

                        Dynamic rheology temperature ramp data for PVC films prepared using 70 phr plasticizer, 2.5 phr stabilizer, and 0.25 phr lubricant.


PVC Plasticizer for Medical Applications

     

    Citroflex™ B-6 almost entirely mimics the properties of diethylhexyl phthalate (DEHP) plasticizer by providing a low intractability and stabilizing effect of lipidic composition within blood bags; all while maintaining a clean toxicological profile as a phthalate-free plasticizer.

     

    Citroflex™ B-6 supports flexible PVC medical tubing in maintaining softness and cracking resistance when exposed to low temperatures. Compared to competitive phthalate-free alternatives, Citroflex™ B-6 plasticizer reduces the potential for plasticizer migration.


Summary

Vertellus Citroflex™ citric acid esters are excellent phthalate-free alternatives and are ideal for bio-polymer systems where end-of-life biodegradability is desired. Medical PVC plastics require a clean toxicological profile that performs well without compromising sustainability or health. A proven drop-in replacement for DEHP, Citroflex™ B-6 assures PVC compounders of production capability while meeting stringent regulatory standards. Talk to a specialist today about Citroflex™ B-6 and how it can benefit your medical device formulation.

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