Hospitals still depend on PVC medical tubing that wants to give up its phthalate plasticizers. The industry is pouring energy into keeping those additives in place. Instead, the industry could move to TPE tubing plasticized with high-purity white mineral oil and leave hormone-mimicking phthalates behind. Questions? Contact us.
Walk through any hospital, and you’ll see flexible medical tubing everywhere: IV lines, ventilator circuits, drainage sets, blood bags. Much of it is made from polyvinyl chloride (PVC).
PVC by itself is rigid. To make it soft and bendable, formulators add plasticizers, most often phthalates. Those small molecules sit between polymer chains and let the tubing flex without cracking.
But there’s a built-in problem: plasticizers tend not to stay put.
Where PVC in Medical Tubing Falls Short
Over time, plasticizer molecules can migrate to the surface of the PVC, then into the fluids inside the tubing, and finally into the patient.
Plasticizer migration erodes performance and elevates compliance risk in PVC products, especially in medical applications.
That risk matters because many phthalates are classified as endocrine-disrupting chemicals (EDCs). They can mimic or interfere with hormones in the body and have been linked to reproductive, developmental, and metabolic concerns.
“Phthalates are widely used chemicals that act as endocrine disruptors and are detrimental to human health.” — Wang et al., Phthalate Exposure and Long-Term Epigenomic Consequences: A Review
Public-health groups like the Minderoo Foundation now spotlight phthalates as one of a handful of plastic chemicals of greatest concern and are calling for stricter global regulation.
For any medical device that touches blood, nutrients, or drugs, this is more than a theoretical issue. It is a design weakness of flexible PVC as a medical tubing material.
“Heroic” Surface Strategies to Keep Phthalates In
An impressive toolkit of surface-modification strategies is used to slow plasticizer migration from PVC.
In simple terms, here’s what those strategies try to do:
- Change the tubing surface so plasticizer molecules have a harder time reaching the surface and into the liquid that may enter your body.
- Add ultra-thin barrier layers to block plasticizer molecules at the interface.
- Alter surface chemistry so plasticizers are less likely to dissolve into blood, saline, or drug solutions.
Technically, these approaches are elegant. They aim to tighten the near-surface polymer network to reduce “free volume,” the space between polymer molecules where plasticizer molecules can slip in, and raise the “energy barrier” for migration into the contacting fluid.
These strategies can help extend product life and reduce extractables. However, they also:
- Add complexity and process steps.
- Require extensive testing and validation.
- Still work around the same core issue: a hormone-mimicking plasticizer in direct contact with patients.
In other words, the industry is making extraordinary efforts to manage a risk that is built into the material system itself.
Phthalates and Cardiovascular Deaths
A recent global analysis linked phthalate exposure to an estimated 350,000 cardiovascular-related deaths in 2018, underscoring the scale of the public-health burden from these “everywhere chemicals.”
Change the Material System, Not Just the Surface
There is another option: change the tubing material and the plasticizer.
Thermoplastic elastomer (TPE) medical tubing has been gaining traction as an alternative to flexible PVC in many applications. TPE systems can deliver the softness, kink resistance, and clarity that designers expect from medical tubing without relying on phthalate plasticizers.
When white mineral oil is used as the plasticizer in TPE:
- No phthalate plasticizers are introduced into the system.
- The plasticizer is a highly refined, chemically inert, high-purity hydrocarbon fluid.
- The same family of materials is already widely used in food, pharmaceutical, and cosmetic products, as well as in polymeric compounds as a plasticizer.
Highly refined white mineral oils are colorless, odorless, and tasteless, virtually free of sulfur, nitrogen, and aromatic hydrocarbons, and have a long history of use in food-contact, cosmetic, and pharmaceutical applications under strict regulatory frameworks.
By transitioning from PVC + phthalates to TPE + white mineral oil, medical device designers can root out the phthalate issue from the source instead of managing it at the surface.
What This Means for TPE Compounders and Medical OEMs
If you formulate TPE compounds or specify medical tubing, the PVC story—and the laborious attempts to keep phthalates contained—points to a clear market signal: healthcare wants phthalates out of human-contact applications.
That creates an opportunity to differentiate with TPE medical tubing plasticized with white mineral oil.
Here are a few of the design levers and advantages to consider as you work with your TPE supply chain and customers.
- Material performance, not just compliance. You can tune TPE + white mineral oil systems for:
- Softness and flexibility
- Kink and crush resistance
- Transparency or translucency
- Weldability and bondability to connectors and bags
- Lower inherent extractables risk vs. phthalate PVC. Phthalates are under intense scientific and regulatory scrutiny because of their endocrine-disrupting potential. By designing around non-phthalate plasticizers from the start, you eliminate the chance of those substances appearing in extractables and leachables profiles.
- Cleaner regulatory story for patients and providers. Hospitals and group purchasing organizations increasingly ask for phthalate-free products, especially in neonatal, pediatric, and reproductive-health settings. Phthalate-free TPE medical tubing can support those purchasing policies and simplify messaging to clinicians and patients.
- Supply-chain and documentation advantages. High-purity white mineral oils used in TPE compounding come with:
- Clear alignment to food and pharmacopeial standards
- Robust certificates of analysis (COAs) and change-control practices
- Global regulatory support for multi-region device launches
- Strategic positioning with your OEM customers. Instead of being on the defensive about PVC phthalates, you can go to market with:
- A phthalate-free tubing solution
- A story grounded in endocrine-disruptor science and public-health guidance
- A long-term material roadmap that anticipates where regulation and hospital policy are headed, not where they’ve been
May this brief roadmap help clarify where to focus development work as you consider moving away from PVC in your tubing portfolio.
How Renkert Oil Helps You Build the Next Generation of Medical Tubing
If you’re ready to explore TPE medical tubing with white mineral oil plasticizers, the right specialty oil partner matters.
Renkert Oil can help you:
1. Select the right white mineral oil grades for your TPE system.
Matching viscosity, volatility, and purity to your specific styrenic, olefinic, or other TPE chemistries is key to hitting your mechanical and processing targets. White mineral oils are already well-established as plasticizers in thermoplastic elastomers, including styrenic block copolymers (TPE-S) used in many soft-touch and medical-adjacent applications.
2. Align performance with regulatory expectations.
Our team can help you think through the interplay between:
- Material selection
- Regulatory frameworks for food and pharma contact
- The documentation your OEM and device-maker customers will expect
3. Strengthen your supply security as demand grows.
As more healthcare buyers seek phthalate-free options, demand for suitable plasticizers will follow.
As a white oil producer, Renkert Oil can formulate white mineral oils to your exact specifications. We source raw materials from multiple suppliers for industry-leading supply security, aligning volumes with your forecast to keep your medical tubing line running.
4. Collaborate early with your development teams.
The best time to rethink plasticizers is when you’re already revisiting formulations for new device generations or new markets. Bringing Renkert Oil in early can shorten your trial-and-error cycle and get you to a robust, scalable formulation faster.
The Bottom Line for Medical Tubing
The industry’s current path is clear: keep flexible PVC in place and develop ever more sophisticated surface treatments to slow phthalate migration.
There is another path.
By shifting to TPE medical tubing plasticized with high-purity white mineral oil, compounders and OEMs can:
- Deliver the softness and performance clinicians expect.
- Eliminate hormone-mimicking phthalate plasticizers from the design.
- Align more naturally with evolving science, regulation, and hospital policy.
If you’re looking at the next generation of medical tubing and wondering how to move beyond phthalates, Renkert Oil is ready to talk through your options. We’ll help you build a cleaner, more future-ready material system from the plasticizer up.
Let’s talk TPEs! Contact Renkert Oil today.