The PVC used in a medical device is not evaluated like that used in food packaging. Here, the law governs. pharmacopoeiaThe product is subjected to extraction reagents, and the released components are characterized. This necessitates an exceptionally clean stabilization system and requires decisions to be made before qualification, such as selecting the antioxidant based on the sterilization method.
From our warehouse in Mexico we supply the additives for medical PVC: the stabilizer MgAlZn MW-33 (medical star product, free of alkylphenols), CaZn FDA/medical MW-11, octyl tin medical LOX-9808L and plasticizers (TOTM, DOTP), in partial batches.
We work with device manufacturers who require traceability and compliance documentation upon request. We deliver in smaller quantities or by full container load at preferential rates.
The most regulated application of medical-grade PVC: the material is in direct contact with the product, and the entire system is subjected to extraction reagents defined by the pharmacopoeia. The whole package—stabilizer, plasticizer, and co-stabilizer—is chosen for its extractable profile rather than its process performance. It's a formulation that is evaluated on a case-by-case basis; write to us, and we'll review which additives from our portfolio are compatible with yours.
The transparent, flexible tubing must remain clear, maintain its flexibility throughout the device's lifespan, and not release any fluid into the container. It requires a clean, low-volatile stabilizing system and a plasticizer selected for its low migration.
Rigid, transparent film for primary drug packaging. Clarity depends on complete melting, and the reference stabilizer in rigid, transparent film is tin, because it maintains thermal stability without generating the carbon spots or yellowing that ruin a film viewed against the light.
Rigid and semi-rigid injection-molded parts subjected to high shear stress in short periods require a stabilizer to withstand this process and an impact modifier to prevent fracture during assembly and use.
| Function | Chemical Additives Products | Specific application |
|---|---|---|
| Low molecular weight suspension resin | K 58 PVC resin | Blister pack and rigid transparent sheet; low in gels and with excellent thermal stability |
| Medium/low molecular weight suspension resin | K 61 PVC resin | Thermoformable calendered sheet, semi-rigid parts, valves and connectors |
| High porosity suspension resin | K 70 PVC Resin | Medical tubing and venoclysis: flexible extrusion with excellent electrical properties and low gel content |
| Function | Chemical Additives Products | Specific application |
|---|---|---|
| MgAlZn powder (medical star) | MW-33 | Blood bag, IV infusion; alkylphenol-free |
| CaZn powder FDA/medical grade | MW-11 | Film/compounds with high toxicological requirements |
| Octyl tin | LOX-9808L | Medical and pharmaceutical rigid film and sheet; the reference system for blister packs |
| Methyl tin | RT-198 | An alternative to blister packaging and rigid sheets in markets that accept it: it yields with a lower dosage and provides excellent initial color and transparency. Its availability and cost are more favorable than those of octyl tin. |
| Function | Chemical Additives Products | Specific application |
|---|---|---|
| Low migration plasticizer | TOTM | Medical instruments |
| FDA plasticizer | DOTP | Medical applications |
| Co-stabilizer | Epoxidized Soybean Oil (ESBO) | Captures HCl, supports stability |
| Optical brightener | Optical brightener | The transparent tubing and IV line enhance the visual appeal of the finished product. |
| Function | Chemical Additives Products | Specific application |
|---|---|---|
| Acrylic process aid | PA-912 | It accelerates gelation and homogenizes the melt: this is what allows the blister's clarity to be achieved and supports the sheet during deep thermoforming. |
| Function | Chemical Additives Products | Specific application |
|---|---|---|
| MBS for crystals | LB-136, MB 875 | Blister pack and clear sheet: provide impact without compromising clarity, and are FDA approved for indirect food contact |
| Rule | Applicable Chemical Additives | Relevance |
|---|---|---|
| Free from alkylphenols (BPA, nonylphenol) | MW-33, MW-11 | Medical device entry requirement |
| Suitable for medical and pharmaceutical use | LOX-9808L, MW-11, MW-33 | Declared in the product data sheet |
| FDA 21 CFR | MW-11, DOTP, LOX-9808L, RT-198 | Pharmaceutical packaging and components in contact |
| FDA — indirect food contact | LB-136, MB 875 | Impact modifier for blister and foil |
| EN 71-3 | MW-33, DOTP | When the device falls within the scope of regulated products |
Immediate availability in national warehouse. Alkylphenol-free, plasticizer-free and epoxidized stabilizers in stock for delivery within 24-72 hours in Mexico.
Partial lots or full container loads at preferential prices. We deliver in the quantity that suits your operation.
One-stop shop for your prescription medication. Resin, stabilizer, plasticizer, processing aid and epoxidization with a single supplier and single traceability.
Compliance documentation available upon request. Letters from the manufacturer to integrate into the technical file of your device.
Batch traceability. In a product that is graded once and audited afterwards, knowing which batch each kilo came from is not an extra.
Backup in crisis. If your usual supplier experiences delays or changes specifications without notice, we'll cover you with qualified material within days.
An excess of zinc in the stabilizing system can cause a sudden and catastrophic degradation of the color, without prior warning during the process. RecommendationThe solution isn't to increase zinc, but to balance the entire system along with the soybean epoxidation. MW-33 and MW-11 are formulated for this balance. Contact us to review your dosage.
Anticipating it changes the choice of antioxidant. Recommendation: Define the appropriate antioxidant before qualifying, according to the sterilization method.
Recommendation: work with alkylphenol-free stabilizers (MW-33, MW-11) and keep the package as simple as possible.
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Do you prefer the finished compound? Chemical Compounds offers compounds for medical devices. View portfolio.
