Pharmaceutical packaging is undergoing a quiet revolution. Once dominated by glass, the market has shifted rapidly toward advanced polymer formats, especially in high-volume drug delivery methods. In 2023, polymer-based packaging accounted for over 35% of the $139 billion global pharmaceutical packaging market, with North America leading the charge. 

What’s behind this growth? Factors range from improved barrier properties, patient safety and convenience, rising demand for child resistant packaging, tamper resistant packaging, and smart packaging solutions.

But behind every sterile tube or packaging type lies a complex process of handling polymer powders and additives. And that’s where bulk ingredient automation is important, because pharmaceutical packaging is a major factor in public health and safety.

Here’s how pharmaceutical manufacturers and contract packagers in the pharmaceutical sector can meet stringent hygiene standards, manage flow variability, and reduce risk at every point in the ingredient handling process. Primary packaging concerns for the pharmaceutical industry include some of the following.

Top Ingredient Handling Challenges (and Packaging Solutions) in Pharma Polymer Manufacturing

1. Switching from DEHP to DEHT

We’ve recently seen a big shift in plasticizer use due to new regulatory requirements. Plasticizer oil — Di(2-ethylhexyl) phthalate (DEHP) — has been used widely to make polyvinyl chloride (PVC), which is then used to make medical film and tubing.

However, DEHP “may leach from plastic equipment directly into the blood,” according to the U.S. Agency for Toxic Substances and Disease Registry. Highest exposures occur during blood transfusions and hemodialysis. In 2024, California passed a law phasing out the use of DEHP by the year 2030, prompting manufacturers to change their formulations.

The replacement, DEHT or Di(2-ethylhexyl) terephthalate, needs a new treatment in an ingredient handling system. We’re currently working with a manufacturer to make the packaging material switch. For example, the ingredient needs to be segregated from DEHP while DEHP is being phased out, and analyzed for flowability to maintain the same level of quality, medical-grade finished product.

2. Medical-Grade Standards

Ensuring that construction materials meet medical-grade standards introduces far more stringent requirements than those found in other industrial environments. Equipment must feature higher surface finishes, and all product contact weld seams must be continuously welded, levelled, and ground to a fully polished finish to prevent the transfer of toxins, allergens, or bacteria into pharmaceutical products. 

Unlike a building materials manufacturer who can tolerate minor cracks or crevices on interior product contact surfaces, a producer of pharmaceutical-grade polymers must eliminate every surface irregularity. For example, receivers — often built as a cylindrical body with a conical bottom — are fabricated in separate pieces, then fully welded, ground smooth, and sometimes polished to a specified finish. This creates a seamless wall that prevents dust or residue from collecting and potentially contaminating the product.

Material selection for gaskets and seals adds another layer of complexity. Although manufacturers may offer 15 to 20 types of plastics and rubbers, only a subset is suitable for medical applications.

Common rubbers suitable for product contact are:

• Viton
• EPT
• Neoprene
• Silicone

Common plastics suitable for product contact are:

• PVC
• Delrin
• UHMW
• Polyethylene
• PEEK 
• HDPE
• Nylon

3. Angel Hair 

Many operations produce plastic pellets on-site by running raw materials through an extruder, where the formulation is mixed, melted, and pushed through a die. AZO equipment can pneumatically transfer these pellets into storage vessels to protect material integrity before the next processing step.

From storage, the pellets move to injection molding machines, pneumatically conveying pellets this stage can introduce a familiar challenge: angel hair. As pellets travel through conveying lines, friction can generate enough heat to soften their outer surface, creating thin, streamer-like strands that accumulate and restrict flow. Optimized material handling and conveying strategies are essential to minimizing angel hair, keeping lines efficient, and ensuring consistent downstream processing.

4. Traceability & FDA Certifications

Implementing traceability and maintaining Food and Drug Administration (FDA) compliant materials are essential requirements for pharmaceutical polymer production. Every component that comes into contact with product — gaskets, seals, tubing, and metal assemblies — must carry proper FDA certification. 

During audits, FDA inspectors may request documentation verifying that each material meets regulatory standards. If a plant cannot produce certifications, it may face citations, forced component replacement, and costly disruptions. In some cases, the FDA can halt operations until compliance is restored.

Traceability must also be built directly into the manufacturing process, according to the Drug Supply Chain Security Act (DSCSA). If an issue arises in the field, the FDA expects manufacturers to track the problem back to its origin, including the batch number, the materials used to produce it, and the conditions under which it was made.

5. Powder Flow Variability

Polymer powders vary widely in flowability. While some ingredients flood easily, others clump, cake, or compact under pressure, especially in humid environments. Poor flow can disrupt dosing accuracy or cause unexpected downtime. 

AZO conducts material-specific flow tests in our lab and engineers conveying systems — like vacuum or pressure pneumatic conveying — matched to both your materials and layout needs. Technologies like deblockers or agitators may be introduced at transfer points to promote consistency.

6. Accuracy in Micro-to-Bulk Dosing

Maintaining precise dosing is absolutely necessary in medical-grade film production, where acceptable tolerances are far tighter than in most other industries. Even a slight deviation in ingredient weight can compromise an entire batch, from micro-dosing through bulk handling.

Dosing screws provide controlled, repeatable delivery of materials, while COMPONENTER® scales are used for minor ingredients that require exceptionally high accuracy at very low quantities. Together, these systems help ensure that every component is added within the narrow limits required for compliant, high-quality output.

7. Regulatory Compliance and Hygiene

Pharmaceutical packaging lines must meet current Good Manufacturing Practices (cGMP), as outlined in 21 CFR Parts 210–211. Systems must support validated cleaning protocols, prevent contamination, and enable complete traceability. Product-contact surfaces typically require higher-grade stainless steel — 316 rather than 304 — because of its superior corrosion resistance. Whether in tubing, receiver bodies, rotary valves, dosing screws, or mixers, painted steel is unacceptable, and every material must be documented to ensure full compliance throughout the line.

8. Dust Mitigation and Explosion Risk

Resins and powdered additives are combustible under the right conditions. NFPA 660 now consolidates combustible dust requirements across industries, and manufacturers are increasingly accountable for sharing material properties with equipment suppliers. AZO incorporates explosion venting, dust-tight seals, and NFPA-compliant grounding into every system. Our equipment is designed to prevent powder leakage and contain dust at every transfer point.

9. Production Agility and Line Versatility

The rise of personalized medicine and niche formulations means lines must adapt. Whether you’re switching between polymer types or altering ingredient ratios, you need equipment that supports fast changeovers and modular expansion. AZO builds ingredient handling systems that scale, from single-line contract manufacturers to high-throughput global producers. Our modular design philosophy guarantees that your system can evolve with your product mix.

Meet Compliance and Scale With Smart Automation

As reshoring accelerates in the U.S., pharmaceutical companies are building new facilities or upgrading aging lines to support domestic drug manufacturing. To meet pharma packaging demands, your powder handling systems need to be:

• Compliant with FDA, NFPA, and DSCSA regulations
• Hygienic for sterile and cleanroom environments
• Precise to deliver consistent dosing and traceability
• Efficient to reduce waste and maximize yield
• Flexible to support multiple product formats and batch sizes

AZO supports projects from development through delivery. That includes lab testing, full-system design, installation oversight, and site acceptance testing (SAT). Our integration with upstream and downstream equipment allows for every part of your process to work in harmony.

Need help navigating polymer packaging production challenges? Contact us today.