The use of plastics in the pharmaceutical industry is broad. It ranges from the equipment and tools used in manufacturing and testing to pharmaceutical delivery systems, such as inhalers and syringes, to packaging. Engineering plastics for pharmaceuticals is the preferred choice for applications requiring a robust solution.
What are Engineering Plastics for Pharmaceuticals?
In general, injection-molded plastics offer numerous benefits to the pharmaceutical industry, including cost advantages, precision tolerances, and application flexibility. However, engineering plastics are used across industries because of their enhanced mechanical and thermal properties compared to commodity plastics like polyethylene or polypropylene. They are generally used when high strength, stiffness, temperature, resistance, or all these properties are required.
There are many engineering plastics with properties that are beneficial for pharmaceutical applications, including:
- Acetal (polyoxymethylene or POM) is a strong, stiff plastic with good dimensional stability and excellent resistance to wear and abrasion. It is commonly used for components of drug-delivery devices, such as syringes, inhalers, and pumps. Acetal can also be used for packaging and containers due to its chemical resistance and low moisture absorption. However, it isn’t recommended for applications where it may overheat as it releases formaldehyde at temperatures over 230°C (446°F).
- Nylon (PA) is a synthetic polymer known for its toughness, resistance to wear and tear, good chemical resistance, low coefficient of friction, and ability to withstand high temperatures. Nylon is a strong and flexible plastic commonly used for packaging and drug delivery devices.
- Polycarbonate is a tough, transparent plastic resistant to impact and high temperatures and can withstand sterilization. It is often used for drug delivery devices, packaging, and laboratory equipment.
- PEEK (Polyether Ether Ketone): a high-performance thermoplastic with excellent mechanical, thermal, and chemical resistance properties, making it suitable for use in demanding applications where high strength and temperature resistance are required. PEEK is often used for components of drug delivery devices, such as syringes, pumps, and inhalers. Due to its resistance to chemicals and solvents, it is also used for laboratory equipment, such as chromatography columns and filtration systems.
- ABS (Acrylonitrile Butadiene Styrene) is a thermoplastic with good impact resistance, heat resistance, chemical resistance, and toughness. ABS is used for drug delivery devices, laboratory equipment, and other applications in the pharmaceutical industry.
- PET (Polyethylene Terephthalate) is a strong, lightweight, and chemically resistant material ideal for packaging applications in the pharmaceutical industry, such as bottles, blister packs, and vials. It offers excellent barrier properties, which help to protect the contents from moisture, oxygen, and other environmental factors affecting their quality and shelf life.
- PMMA (Polymethyl methacrylate) offers excellent optical clarity and is resistant to impact and chemicals. It is often used in medical and pharmaceutical applications, such as diagnostic equipment and drug delivery devices.
Choosing an Appropriate Engineering Polymer
The chosen engineering polymer will depend on the specific application requirements, such as chemical compatibility, temperature resistance, and mechanical properties. It is important to note that regulatory compliance is the responsibility of the manufacturer of the pharmaceutical product, and they must ensure that all materials used in the product meet applicable regulatory requirements.
The FDA regulates plastics used in contact with drugs under its Code of Federal Regulations (CFR) Title 21. The Regulation sets forth specific requirements for plastics in drug packaging. The FDA also requires that plastic materials used in pharmaceutical applications be tested for biocompatibility, cytotoxicity, and other factors affecting the product’s safety.
The Current Good Manufacturing Practice (cGMP) regulations (21 CFR part 210 and Part 211) ensure pharmaceutical products’ quality, safety, and effectiveness. CGMP regulations establish standards and requirements that manufacturers must follow during production, processing, packaging, and testing. For example, the equipment used in pharmaceutical manufacturing must be designed in a way that makes it easy to use and clean, and the surfaces of the equipment that encounter the drug products must not react with or absorb any substances that could change the quality, safety, or effectiveness of the product. A plastic injection molded component must be compatible with the drug product it encounters and not react with it or leach anything into it.
A Partner to Meet Your Needs
In addition to meeting industry standards and regulations, timely delivery and top-notch quality are paramount. At SEA-LECT Plastics, we implement a robust quality control system that guarantees the delivery of premium products. Our certification to ISO 9001:2015 as an injection molder underscores our commitment to meeting our customers’ needs every time. With our start-to-finish turnkey production approach, we can expedite the production process and deliver your product quicker, allowing you to get to market faster. If you have questions or considering engineering plastics for pharmaceuticals, give us a call.