Scenarios with high DEHP-exposure

FDA (US), CSTEE (EU) and BfArM (Germany) see concern for the following applications:

• Neonates:

- Exchange transfusion
- Extracorporeal Membrane Oxygenation (ECMO)
- Total Parenteral Nutrition (TPN with lipids in PVC bags)
- Multiple procedures in sick neonates

* Hemodialysis in peripubertal males, in pregnant or lactating women
* Enteral nutrition in neonates and adults
* Heart transplantation
* Massive infusion of blood (trauma patient)
* Transfusion in adults while in ECMO

Risk Assessment for Medical Devices

What the alternatives should deliver and what should be the properties and one thing that is important that alternative should deliver same benefits at a lower risk. So you have to balance the benefit of a product, goal and treatment of patient while looking for alternatives. And the main goal is to reduce the risk that can be done by reducing the hazards of a substance that relates to toxcicity, or reducing the exposure , that directly relates to exposure to chemical substance for example migration , if plasticizer does not migrate out of finished article you would have zero exposure and by this having lower risk.

Alternative for Medical Devices

There is an alternative developed by BASF - The Chemical Company , Hexamoll® DINCH, an innovative non-, phthalate plasticizer ; with high favorable toxicological profile and it is based on core hydrogenation of DINP (Di-IsoNonyl-CycloHexane-dicarboxylate)

With the help of core hydrogenation, we transfer the DINP into a different substance which has different toxicological profile and at the same time maintaining good technical properties for compound flexible PVC article processing. The Core Hydrogenation is a one-way process and DINCH is a STABLE MOLECULE. In 2002 , it was produced at a dedicated production of 25kt but due to increase in market demand we increase the production to 100kt in the year 2007. The company is having a dedicated infrastructure which assures highest quality.

The Hexamoll Dinch is the researched plasticizer in the market and has been successfully tested. There is availability of data based on most stringent testing methods. 5 million Euro has been spent on the testing and there is no data gap. All results shows that it has an excellent toxicological profile.

Some of the important test results are :-

• Environmental hazards           NO
• Peroxisome proliferation        NO
• Reproductive hazard              NO
• Testicular toxicity                   NO
• Impairment of fertility             NO
• Developmental toxicity           NO
• Teratogenicity                        NO
• Endocrine action                    NO
• Accumulation within the body NO
• Carcinogenicity                      NO

The Hexamoll Dinch has wide compliance with regulations on sensitive applications and some of the examples are given below:

The Hexamoll Dinch is the right choice for the medical plastics disposable products and some of the favorable properties as compared to DEHP are:

- Non-p plasticizer of choice for medical applications
- 8-time lower migration than DEHP for enteral feeding solution
- Hazard & exposure reduced

The Hexamoll Dinch has been sucessfully used by many medical devices companies like Pfrimmer Nutricia, Medizintechnik GmbH, Raumedic and for the products like Medical Tubings for Enteral Feeding Sets, Haemodialysis, Medical Bags for Saline , Blood Plateletes & Gloves.

Advantages of Hexamoll® DINCH :

- Good compatibility with PVC
- Good processability
- Low volatility
- High cold flexibility
- No smell
- Low migration
- Excellent toxicological profile
- Lower risk as hazard and exposure are considerably reduced
- Suitable for common sterilisation methods (low-temperature plasma (LTP), steam, gamma ray, ethylene oxide
- Allows USP-Class VI - compliance
- Masterfile for 510k-submission submitted at FDA

To sum up, with Hexamoll Dinch BASF- The Chemical Company offers A Non-phthalate plasticizer having a proven excellent toxicological profile alongwith good technical properties ,a wide range of regulatory approvals and the support and reliability of - BASF - The Chemical Company.

(This article is based on presentation given during the conference on, "Indian Medical Devices & Plastic Disposables Industry 2008", at AMA, Ahmedabad, Feb. 24 - 25, 2008").