Phthalate-Free Plasticizer for Medical Applications

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.

Aurorium 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

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.

Aurorium 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.