Case study: Safe alternative to phthalates for medical applications

Additives:
Bio-based Plasticiser

Polymer: PVC

Application:
Medical Tubing, Bags and Injection Moulded parts 

Key Benefits:

  • Safe Toxicological Profile
  • Easy and equivalent processing capabilities to DEHP (DOP)
  • Improved performance vs phthalates
     

Your Challenge
Finding a plasticiser for your PVC applications that mimics DEHP (DOP) in terms of its processing capability and yet at the same time fulfilling both technical and toxicological requirements is a challenge.

On top of that, for medical applications, specific regulations and safe product or chemistry need to be taken into consideration.

The Solution
SOFT-N-SAFE™
, a bio-based plasticiser containing 0% of phthalates and offering:

  • Equivalent processing capability to DEHP
  • No need for major adjustments to the standard formulation in terms of plasticising efficiency or gel-fusion temperatures unlike many products on the market.
  • Good Low Temperature properties
  • Clarity and Colour Hold in clear formulations
  • Good Elongation at Break after Accelerated Ageing at 135°C for 7 days 
     

In addition, using SOFT-N-SAFE™ means that no compromise has to be made on performance as illustrated in the following table:

Comparison data between DEHP and SOFT-N-SAFE™

  DEHP SOFT-N-SAFE™
Volatility Loss (ASTM D1203-03) 3.3 0.49
Extraction (water) (ASTM D1239-07) @23°C -0.03 -0.05
Extraction (saline) (ASTM D1239-07) @23°C 0.01 -0.03
Durometer (ASTM D2240) 78 78
Specific Gravity (ASTM D792) 1.24 1.24
Tensile Strength, psi (ASTM D638) 2795 2843
Elongation, % (ASTM D638) 383 419
Static Stability @ 377F 45 45
Delta E (BYK Gardner A65) STD 2.35
Haze (BYK Gardner) 2.35 4.98

(Data provided by Danisco's compounder partner in the US)

SOFT-N-SAFE™ is based on Danisco's Food Ingredient chemistry and demonstrates a safe toxicological profile aligned with the needs of the medical industry.  SOFT-N-SAFE™ passes stringent tests such as the ISO 10993 and various OECD tests on developmental and reproductive toxicity to back the overall image of safe chemistry.

Why it is unique?
Testimony from the spokesperson of Danisco's partner in the US who implemented this solution:

"Finding a non-phthalate plasticiser that makes no compromises has been quite a task and whilst there are options on the market that purport to be 'drop-in' replacements we found only one to be almost identical to the DEHP in terms of its ease of use"

 

© DuPont Nutrition & Health