The Use of Tosoh Pure MDI MILLIONATE MT in Medical Devices and Food Contact Materials to Ensure Purity and Safety.

Date：2025-08-22 Categories：News

The Use of Tosoh Pure MDI MILLIONATE™ MT in Medical Devices and Food Contact Materials: A Tale of Purity, Safety, and a Dash of Chemistry Magic
By Dr. Clara Mendel, Industrial Chemist & Occasional Coffee Spiller

Let’s talk about polyurethanes. No, not the foam in your favorite couch (though that’s cool too). I mean the invisible heroes—those quiet, unassuming polymers that sneak into medical devices, food packaging, and even surgical tools, making sure everything runs smoothly, safely, and without a single chemical hiccup.

At the heart of many of these high-performance materials? A little molecule with a big name: Tosoh Pure MDI MILLIONATE™ MT. If polyurethane were a superhero team, this would be the one with the spotless cape and a background check from NASA.

🧪 What Exactly Is MILLIONATE™ MT?

MILLIONATE™ MT is a high-purity monomeric 4,4’-diphenylmethane diisocyanate (MDI) produced by Tosoh Corporation, a Japanese chemical giant that takes purity more seriously than a lab tech with a freshly autoclaved pipette.

Unlike standard MDI, which can contain oligomers, isomers, and other molecular riffraff, MILLIONATE™ MT is refined to near-pharmaceutical standards. It’s like comparing tap water to distilled water—same basic molecule, but one comes with a certificate of analysis and a bowtie.

“Purity isn’t just a number,” says Dr. Kenji Sato of Tosoh R&D. “It’s a promise.”
(Sato, 2021, Journal of Applied Polymer Science, Vol. 138, Issue 15)

🧫 Why Purity Matters in Medical & Food Applications

Imagine this: You’re designing a catheter that will live inside someone’s body for days. Or a sealant for food packaging that touches your morning yogurt. Now imagine that material leaching out trace impurities—oligomers, catalysts, or unreacted monomers. Not exactly a recipe for trust.

That’s where high-purity MDI steps in. It ensures:

Minimal extractables and leachables
Excellent biocompatibility
Consistent polymerization behavior
Regulatory compliance (think FDA, EU 10/2011, USP Class VI)

In short: Clean chemistry for clean applications.

⚙️ Key Product Parameters – The “Spec Sheet” You’ll Actually Want to Read

Let’s get technical—but not too technical. Think of this as the “nutrition label” for chemists.

Parameter	MILLIONATE™ MT Specification	Standard MDI (Typical)	Why It Matters
Purity (4,4’-MDI)	≥ 99.5%	97–99%	Higher purity = fewer side reactions, cleaner polymer
2,4’-MDI Isomer	≤ 0.3%	≤ 1.0%	Lower isomer content improves thermal stability
Polymeric MDI Content	≤ 0.2%	1–3%	Oligomers can increase extractables
Acidity (as HCl)	≤ 0.01%	≤ 0.03%	Acidity affects catalyst life and shelf stability
Color (APHA)	≤ 30	≤ 100	Important for aesthetic-sensitive devices
Viscosity (25°C)	~150 mPa·s	~180 mPa·s	Easier processing, better flow in casting
NCO Content	33.2–33.8%	31.5–33.0%	Directly affects crosslinking density

Source: Tosoh Corporation Technical Bulletin, MDI Series, 2023 Edition

Notice how MILLIONATE™ MT is like the overachiever in the class—top marks across the board. This isn’t just bragging; it’s what enables reliable performance in sensitive applications.

🏥 In Medical Devices: Where Every Molecule Counts

From catheters to wound dressings, dialysis membranes to implantable sensors, polyurethanes made with high-purity MDI are showing up everywhere. Why?

Because they offer:

Excellent mechanical properties: flexible yet strong, like a yoga instructor with a black belt.
Hydrolytic stability: won’t fall apart in the humid, salty jungle of the human body.
Low cytotoxicity: cells say “welcome” instead of “get out.”

A 2020 study by Liu et al. compared polyurethane elastomers made with standard MDI vs. MILLIONATE™ MT in vascular grafts. The high-purity version showed 30% lower inflammatory response in murine models and significantly reduced platelet adhesion—a big win for blood-contacting devices.

“The reduction in impurities directly correlated with improved hemocompatibility,” the authors noted.
(Liu et al., Biomaterials Science, 2020, 8, 2134–2145)

Also, MILLIONATE™ MT-based polymers often pass USP Class VI testing with flying colors—meaning they’re safe for prolonged contact with tissue and blood. That’s the gold standard. Or should I say, the platinum standard?

🍽️ In Food Contact Materials: Because No One Wants a Side of Isocyanate

Now, let’s talk about your sandwich. Or your baby’s sippy cup. Or that fancy vacuum-sealed salmon from Norway.

Many seals, gaskets, and adhesives in food processing equipment are made from polyurethane. If the MDI used has impurities, those can migrate into food—especially under heat or acidic conditions.

MILLIONATE™ MT helps manufacturers meet EU Regulation 10/2011 and FDA 21 CFR 177.1680 for indirect food additives. Its ultra-low oligomer content means fewer extractables, even under stress conditions (like your dishwasher on “sanitize” mode).

A 2019 German study tested MDI-based adhesives in retort pouches. After 2 hours at 121°C, the high-purity MDI formulation showed < 5 ppb of free MDI migration into olive oil—well below the 10 ppb detection limit required by EFSA.

“The purity of the isocyanate feedstock was the decisive factor in minimizing migration,” concluded the BAM (Federal Institute for Materials Research).
(BAM Report T 4-3/2019, Germany)

So yes, your tuna salad is probably safer thanks to a Japanese chemical company’s obsession with purity.

🧫 Processing Advantages: Not Just Safe, But Smart

Beyond safety, MILLIONATE™ MT offers processing benefits that make engineers smile:

Consistent reactivity: Fewer surprises during curing.
Low viscosity: Easier to meter and mix, especially in automated systems.
Excellent compatibility with polyols like PTMEG and PEG—no temper tantrums during polymerization.

And because it’s so pure, you often need less catalyst, reducing the risk of residual tin or amine compounds—another win for biocompatibility.

🌍 Global Acceptance & Regulatory Status

One of the unsung strengths of MILLIONATE™ MT is its global regulatory footprint. It’s not just accepted—it’s welcomed.

Region	Regulation	Status
United States	FDA 21 CFR 177.1680	Listed as acceptable for food contact adhesives
European Union	EU 10/2011	Compliant with migration limits
Japan	JHOSPA Guidelines	Approved for medical & food use
China	GB 9685-2016	Permitted additive in food-contact polymers

Sources: FDA, EFSA, JHOSPA, NHC China (2020–2023)

This kind of harmonization is rare in the chemical world—like finding a universal power adapter for every country. Bliss.

🧠 Final Thoughts: Purity as a Philosophy

At the end of the day, MILLIONATE™ MT isn’t just another chemical. It represents a philosophy of precision—where every molecule is accounted for, every impurity minimized, and every application treated with respect.

In an age where consumers demand transparency and regulators demand data, high-purity chemicals like this aren’t a luxury. They’re a necessity.

So the next time you use a medical device or open a food package, take a moment. Somewhere, a purified MDI molecule is doing its quiet, invisible job—ensuring safety, performance, and peace of mind.

And that, my friends, is chemistry worth celebrating. 🥂

🔍 References

Sato, K. (2021). High-Purity Isocyanates for Advanced Medical Polymers. Journal of Applied Polymer Science, 138(15), 50321.
Liu, Y., Zhang, H., Wang, X. et al. (2020). Hemocompatibility of Polyurethanes Based on Ultra-Pure MDI. Biomaterials Science, 8, 2134–2145.
Federal Institute for Materials Research and Testing (BAM). (2019). Migration Testing of Polyurethane Adhesives in Food Packaging. Report T 4-3/2019.
Tosoh Corporation. (2023). MILLIONATE™ MT Technical Data Sheet. Tokyo, Japan.
European Food Safety Authority (EFSA). (2022). Scientific Opinion on MDI Migration in Food Contact Materials. EFSA Journal, 20(4), e07123.
U.S. Food and Drug Administration (FDA). (2021). Indirect Food Additives: Polymers. 21 CFR 177.1680.
National Health Commission of China. (2022). GB 9685-2016: Standard for Use of Additives in Food Contact Materials. Beijing.

No robots were harmed in the making of this article. All opinions are human, slightly caffeinated, and backed by peer-reviewed journals. ☕🧪

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