The medical device industry constantly seeks materials that offer optimal performance while prioritizing patient safety. Plasticizers are integral to the flexibility and usability of many medical devices, with Polyvinyl Chloride (PVC) being a common base material. Historically, Di-(2-ethylhexyl) phthalate (DEHP) has been the dominant plasticizer in PVC medical devices. However, increasing concerns about its potential health effects have driven the search for safer alternatives, leading to the prominence of Tris(2-ethylhexyl) Trimellitate (TOTM).

The Need for Safer Plasticizers in Medical Applications

Medical devices such as intravenous tubing, blood bags, and catheters are often in direct and prolonged contact with patients. Plasticizers, like DEHP, are not chemically bound to the PVC and can leach out into the body fluids or medications. Studies have indicated that DEHP may be associated with endocrine disruption and reproductive toxicity, prompting regulatory bodies and manufacturers to look for alternatives that minimize these risks. The demand for DEHP-free medical devices has grown significantly, creating a market opportunity for safer plasticizers.

TOTM: Properties and Safety Profile Comparison

Tris(2-ethylhexyl) Trimellitate (CAS No. 3319-31-1) offers a compelling alternative due to its favorable properties and improved safety profile. While it is still a plasticizer that can leach, research suggests that the extent of leaching and its associated biological effects are significantly less pronounced than those of DEHP. Scientific studies comparing TOTM and DEHP have shown that TOTM exhibits substantially lower toxicity and estrogenic activity. Specifically, the cellular toxicity and the activation of estrogen receptors by TOTM are reported to be approximately 10-fold weaker than those observed with DEHP. This makes TOTM a more suitable and safer option for medical applications where patient exposure is a critical consideration.

Its use in medical devices is supported by its excellent low migration characteristics, which further reduces the risk of patient exposure. This is particularly important when devices are used with lipophilic substances or during long-term patient care.

Applications of TOTM in Medical Devices

TOTM is increasingly being adopted in the manufacturing of various medical devices, including:

  • Enteral feeding tubes
  • Intravenous fluid bags and tubing
  • Dialysis equipment
  • Catheters

Its ability to provide the necessary flexibility and durability to these devices, combined with its superior safety profile compared to DEHP, makes it a preferred choice for healthcare product manufacturers. For companies looking to purchase TOTM, sourcing from a reputable manufacturer in China, such as NINGBO INNO PHARMCHEM CO.,LTD., ensures access to a high-quality, consistent product that meets the stringent requirements of the medical industry.

NINGBO INNO PHARMCHEM CO.,LTD. – Your Trusted Partner for Medical-Grade Chemicals

NINGBO INNO PHARMCHEM CO.,LTD. is committed to supporting the medical device industry with safe and effective chemical solutions. As a leading supplier of Tris(2-ethylhexyl) Trimellitate in China, we provide a product that meets exacting standards for purity and performance. By choosing our TOTM, you can confidently develop medical devices that are not only functional but also prioritize patient well-being, offering a crucial advantage in a highly regulated market.