Minimizing Risk in Medical Plastic Processing

Plastics used in healthcare devices, such as inhalers, must meet rigorous quality, performance, biocompatibility, and biotoxicity standards.

In the medical and pharmaceutical sector, risk management is paramount. Manufacturers of devices and pharmaceutical packaging, along with their customers, must ensure that every component can be used safely without compromising patient outcomes. This responsibility extends to suppliers of component parts, who must also guard against defects that could affect the final product.

Medical plastics enable fast diagnosis, minimally invasive surgery, self‑medication, and reduce bacterial transmission. They also protect drugs from moisture and oxygen. These materials must consistently resist sterilization, chemicals, and lipids while meeting biocompatibility and toxicity requirements. Even minor changes to the plastic’s formulation can alter its suitability, so regulatory bodies such as the U.S. FDA and European authorities require detailed documentation of material composition, manufacturing processes, and supporting data on physical and mechanical properties, biocompatibility, and toxicity.

The burden of compiling this documentation ultimately falls on the company marketing the device, as it becomes part of the regulatory dossier needed for approval. However, as regulators tighten scrutiny of supply‑chain changes, processors—from Tier 1 down to Tier 3 suppliers—are increasingly held accountable for the materials they source, even when those specifications come from the OEM.

Early collaboration across the supply chain, starting at the design phase, is essential. While plastic parts may represent a small cost per device, they play a critical role in device reliability. A processor that understands risk‑management principles, maintains rigorous change control, and invests in Good Manufacturing Practices (GMP) can become a valuable partner to manufacturers.

What is a Medical‑Grade Polymer?

There is no single “medical‑grade” polymer; any resin can be used in a medical application if it is “well‑characterized” and its variability is tightly controlled. This means that potential risks have been assessed and deemed acceptable. Proper documentation allows device manufacturers to incorporate the material with confidence, but any change in material or formulation during the product’s life cycle can invalidate prior approvals.

Change control is therefore critical. Alterations anywhere in the supply chain—at the production site, in the process, specification, or quality system, even minor ingredient tweaks—can impact material characterization.

Historically, device manufacturers monitored only their direct Tier 1 suppliers, who were expected to manage their own sub‑suppliers. The FDA now requires manufacturers to take responsibility for Tier 2 and Tier 3 suppliers, ensuring that every link in the chain complies with GMP and change‑management requirements.

ISO 13485‑2016 is the standard governing design, production, installation, and servicing of medical devices. When upstream suppliers, such as plastics processors, hold ISO certification, they demonstrate a commitment to medical‑device risk‑management principles, quality control, testing, and documentation for raw materials.

Using a material that worked in earlier devices does not guarantee future acceptability. The FDA has issued several guidelines addressing this issue.

What to Look for in Materials

Serious suppliers of medical‑pharmaceutical materials understand end‑use requirements, regulatory frameworks, risk‑management practices, and have robust change‑control measures. This typically involves enhanced GMP and certification to ISO 13485‑2016.

Companies like Borealis (Bormed polyolefins) and Lyondell Basell (Purell range) offer dedicated portfolios for healthcare applications. These grades are produced in the same reactors as commercial grades but under tighter quality controls, with change‑notification commitments, long‑term supply guarantees, and pre‑testing against relevant healthcare regulations.

When polymers are modified with colorants or additives, a broader range of parameters and ingredients must be controlled. Avient’s Mevopur line—both finished compounds and color/additive masterbatches—provides similar assurances. (Avient emerged from PolyOne’s acquisition of Clariant Masterbatches.)

Such procedures are still exceptions; many production processes are subject to frequent ingredient changes for economic reasons. Careful sourcing at each supply‑chain level is therefore essential to ensure that materials come with the necessary assurances and controls.

Standards bodies are working to define “medical‑grade” plastics. VDI’s VDI:2017 covers polymers, while MedPharmPlast Europe, a vertical trade association covering the entire medical‑pharmaceutical supply chain, is developing a broader standard that includes downstream modifications.

Given the increasing use of medical and drug‑delivery devices, it is crucial that colorants and additives receive the same level of scrutiny as the polymer base.

What About Colorants & Additives?

Colorants and additives can be pre‑compounded into the polymer or added via masterbatch during molding or extrusion. While the primary polymer may be carefully selected, these minor ingredients can be overlooked, leading to future issues.

The FDA treats colorants and additives as “contaminants” of the polymer, requiring them to be controlled to the same degree as the base material. OEMs often specify a color standard (e.g., Pantone, RAL) and rely on the processor to source it. Processors may choose a familiar colorant or additive, assuming it is “proven.” The FDA disagrees, as any change—however small—must be reassessed and fully documented.

Regulatory compliance hinges on the weakest link. Because pigment and additive suppliers rarely provide change notifications, processors must adopt robust practices. Avient’s Mevopur team, for example, employs “fingerprinting” of incoming materials to detect changes.

Avient’s Lewiston, Maine, compounding line—one of three global Mevopur facilities—operates in a segregated environment to minimize contamination.

ABOUT THE AUTHOR: Steve Duckworth is global head of marketing & business development for healthcare at Avient Corporation, a company formed by PolyOne’s acquisition of Clariant Masterbatches. He joined Clariant in 2007 and played a key role in launching the Mevopur line of “Controlled, Consistent and Compliant” color and additive masterbatch concentrates and polymer compounds for the medical and pharmaceutical sectors. His global team collaborates with manufacturers and suppliers to reduce risk and swiftly respond to evolving regulations. He serves as president and executive board member of MedPharmPlast Europe and sits on its regulatory affairs committee.