The demand for medical packaging materials, particularly polymers that combine superior performance, regulatory compliance, and safety is increasing. There are a wide variety of materials suitable for medical packaging including Polyolefins (HDPE, LDPE, PP), Polyurethanes (TPU), Polyvinyl (PVC, EVA, EVOH), Polystyrenics (PS, HIPS, ABS), and Polyesters (APET, PETG) each with its own set unique properties that contribute to the safe and reliable delivery of healthcare products and improved patient care. The selection of medical packaging materials often involves evaluating additives used to enhance flexibility, durability, and resistance, while considering potential health and environmental impacts. One such material that has emerged as a preferred choice in medical packaging, especially for sterile medical barrier rigid tray packaging, is Polyethylene Terephthalate Glycol, commonly known as PETG.
PETG is a thermoplastic polymer belonging to the polyester family. It is derived from the polymerization of Polyethylene Terephthalate (PET) and Ethylene Glycol (EG). This unique combination results in a material with exceptional clarity, toughness, and versatility, making it ideal for a wide range of medical packaging applications. PETG, as the name suggests, is a glycol-modified copolymer of PET. However, instead of adding glycol, the glycol component is removed during the polymerization process. PETG is thus produced by replacing EG with Cyclohexanedimethanol (CHDM) in the polymer backbone chain. This modification results in a clear and amorphous polymer with unique properties. Its unique characteristics, such as clarity and toughness, are critical for regulatory and performance testing.
The global PETG market size for Medical and Pharmaceutical Rigid Packaging was valued at USD 194.31 million in 2021 and is expected to expand at a CAGR of 8.66% during the forecast period, reaching USD 319.74 million by 2027. Most of this growth is attributable to extrusion and thermoforming including applications such as trays and blister for medical device packaging.
Supply Chain & Process Advantages
Impact Plastics has developed a new offering of PETG rollstock for the healthcare packaging industry utilizing a specialty grade of PETG resin developed in partnership with Selenis, a global resin manufacturing company that specializes in the production and distribution of specialty polyester and polymer products. Selenis offers a wide range of polyester resins and compounds that cater to various industries, including medical packaging. Through this collaboration, the companies can now offer an alternate supply of medical-grade PETG to OEM medical and pharmaceutical companies in a traditionally sole-sourced market, mitigating supply chain risk and providing supply chain assurance for critical medical device packaging materials.
PETG is typically synthesized through esterification or transesterification reactions. In the esterification method, Purified Terephthalic Acid (PTA) and EG reaction, with water being produced as a byproduct. In the transesterification method, Dimethyl Terephthalate (DMT) and EG reaction, with methanol being produced as a byproduct. Plastic regulatory testing includes physical, chemical, and biological analyses to ensure safety and compliance, which are critical for materials like PETG used in medical and pharmaceutical applications.
Impact PETG 1773 is manufactured using the PTA process, which employs PTA as the primary monomer instead of DMT. PTA is a high-purity monomer that offers several advantages over DMT in terms of quality and performance, ensuring consistent polymerization and resulting in lower levels of impurities and excellent transparency and optical clarity, allowing for easy visual inspection of packaged medical products. This is particularly crucial for medical applications where visual assessment is necessary. This process also results in superior mechanical properties including increased impact resistance and tensile strength for improved package integrity & product protection during transportation, handling & storage. PETG produced with PTA exhibitsThis process has gained popularity and is widely adopted in the industry, leading to increased production and familiarity. The PTA process requires less feedstock consumption, resulting in improved efficiency, reduced waste and a more cost-effective product.
Impact Plastics produces PETG 1773 utilizing a state-of-the-art extrusion line equipped with High Vacuum Twin Screw Extrusion (HVTSE) technology. Traditionally, hygroscopic materials like ABS, PET or PETG required pre-drying, resulting in significant time and energy consumption. However, the HVTSE system incorporates a unique approach with a single atmospheric and dual high vacuum vent system and a co-rotating twin screw extruder. This technology effectively removes moisture and other volatiles during the extrusion process, eliminating the need for separate drying and recrystallization steps, especially for recycled polyesters. The elimination of these steps translates into remarkable energy savings of up to 30-35% compared to conventional methods, making it an environmentally sustainable and clean production option. Rigorous physical and mechanical testing verifies that plastic products like PETG 1773 will perform as expected, preventing defects and recalls. During the manufacturing process, chemical analysis—including control of intrinsic viscosity to ensure optimal product quality—is performed to identify and control impurities and ensure the absence of harmful chemical substances.
The environmental benefits of the HVTSE system are significant, as it reduces energy consumption and waste. Additionally, the process supports the circular economy by enabling the use of recycled and post consumer PETG materials, promoting sustainability within the plastics value chain.
Performance & Compliance Testing:
Impact PETG 1773’s compliance with regulatory standards, biocompatibility testing, and successful results at T0 and further aging and sterilization studies will demonstrate its suitability for sterile medical packaging applications. These certifications and studies provide reassurance to medical device manufacturers, pharmaceutical companies, and healthcare professionals regarding the reliability and performance of PETG in critical healthcare environments. Data collected from various tests is used to ensure compliance with regulatory standards and to provide quality results for end users. Container Closure Integrity Testing (CCIT), which includes methods like vacuum decay and tracer gas testing to identify leaks, is an essential part of ensuring the reliability of sterile medical packaging.
Regulatory Compliance: Impact PETG 1773 is a versatile polymer that meets the compliance requirements for food packaging and medical packaging, ensuring its safety and suitability for these applications. Impact PETG 1773 adheres to both the regulations set forth by the U.S. Food and Drug Administration (FDA) under 21 CFR 177.1315, which governs polyethylene terephthalate resins used in food contact articles, as well as the European Union’s regulations, including European Regulation (EC) No 1935/2004 and Commission Regulation (EU) No 10/2011. These regulations establish the safety standards and specifications for materials intended for contact with food and medical products within their respective jurisdictions. Regulatory compliance involves meeting standards set by organizations like ASTM and the U.S. FDA to facilitate market access. The compliance of PETG with these regulations demonstrates its adherence to the stringent requirements for ensuring the safety and suitability of packaging materials in the medical industry. Examples of regulated chemical substances that PETG must be tested for include phthalates and heavy metals.
Biocompatibility: In addition to the regulatory approvals, Impact PETG 1773 has undergone extensive testing to confirm its biocompatibility and suitability for medical and pharmaceutical packaging. Biocompatibility in medical packaging refers to the compatibility of a material with living tissues or cells. Medical OEMs need assurance that the materials used in their products will not cause adverse reactions or harm to patients. Impact PETG 1773 has been tested and approved according to the USP Class VI standards, which evaluate the biological response of materials in vivo (animal testing) and in vitro (laboratory testing) environments. These tests assess various factors such as acute toxicity, sensitization, irritation, and systemic toxicity to determine the material’s safety and compatibility with biological systems. Impact PETG 1773 has also undergone cytotoxicity testing as per ISO 10993-5:2009 protocols to assess its potential for adverse effects on living cells. Cytotoxicity testing evaluates the impact of a material on cell viability, proliferation, and overall cellular health. Undergoing this testing ensures that the material does not have a toxic effects on cells and demonstrates the suitability of PETG 1773 for use in medical and pharmaceutical packaging applications. Exposure assessments are conducted to evaluate the potential for leaching or migration of substances from PETG into medical products.
Compatibility Trials & 3rd Party Testing:
In addition to achieving the necessary regulatory and compliance certifications for medical packaging applications, Impact Plastics has conducted extensive compatibility trials and 3rd party testing to evaluate the performance Impact PETG 1773:
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Compatibility Trials:
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Extrusion Trial: Successfully conducted extrusion trials of Impact PETG 1773 Blue Tinted Material at 0.030” material thickness with FDA approved Silicon Coating.
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Thermoforming Trial: Successfully produced trays from Impact PETG 1773 to assess processing parameters & performance of rollstock in medical packaging applications, using comparable heat settings suggesting viability as a replacement to incumbent solutions. Further trials will be conducted to assess dimensional accuracy, surface quality and overall part performance.
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Lid Seal Trial: Conducted lid stock trials with a Tyvek-coated lid using a heat sealer machine to assess sealing parameters and seal integrity, confirming compatibility between existing lid-stock solutions and Impact PETG 1773 without a change in process parameters.
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Sterilization Trials: Conducted sterilization trials to assess compatibility and effectiveness of Impact PETG 1773 using common medical packaging sterilization techniques to ensure the highest level of quality, safety & reliability for medical packaging applications where sterilization is a critical requirement:
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Ethylene Oxide (ETO): ETO sterilization is widely used in the medical industry due to its ability to penetrate packaging materials and effectively sterilize sensitive medical devices & components. Impact PETG 1773 trays successfully passed two cycles of commercial ETO sterilization with negative biological indicator results for growth at an incubation time exceeding 48 hours, confirming sterilization efficacy and the material’s ability to withstand sterilization process without compromise to performance or functionality when tested for structural integrity.
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Gamma Radiation Sterilization: A commonly used method in the medical field that involves exposing the packaging material or product to a controlled dose of gamma radiation effectively sterilizing the tray, eliminating microbial contamination, and ensuring the safety & sterility of the packaged products. Impact PETG 1773 trays were successfully gamma sterilized to meet the necessary standard for medical and pharmaceutical packaging applications.
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Additional 3rd Party Testing: Conducted testing through an ISTA certified laboratory to compare performance and suitability of trays produced from Impact PETG 1773 for their integrity and strength to withstand sterilization, as well as accelerated aging and physical testing to evaluate real world test conditions against industry standards. Initial testing was conducted at the T0 interval, which represents the baseline resting point before the trays undergo accelerated aging.
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Seal Integrity - Trays
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Visual Inspection (ASTM F1886): Passed
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Dye Leak (ASTM F1929): Passed
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Seal Strength (ASTM F88): Passed with higher than average seal strength
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Accelerated Aging Conditions – In progress
Materials testing and polymer testing are performed on samples of PETG to validate its performance and safety. Manufacturers and suppliers collaborate to provide information and physical samples for third-party certification and benchmarking, ensuring transparency and traceability throughout the supply chain.
Testing, certification, and benchmarking play a crucial role in the selection of materials for medical packaging applications. These processes validate the safety, performance, and regulatory compliance of sterile barrier packaging materials like PETG to ensure that the material meets industry standards, minimizing the risks associated with packaging failure, contamination, or adverse reactions. Quality results from certified laboratories help ensure compliance and support the manufacturer's reputation.
To learn more about Impact’s PETG and request a full copy of the testing results contact our team. We offer expert advice and resources for customers seeking guidance on regulatory testing or material selection:
Introduction to Plastic Testing
Plastic testing is a fundamental step in the development and manufacturing of plastic materials and products. Through a series of rigorous tests, manufacturers can determine the physical, chemical, and thermal properties of plastics, ensuring that each material is suitable for its intended application. Whether used in electrical equipment, food packaging, or automotive components, plastic testing helps verify that products comply with industry regulations and meet quality and safety standards. By thoroughly evaluating plastics, manufacturers can identify potential weaknesses, optimize performance, and ensure that their products are safe for consumers and the environment. Fourier Transform Infrared (FTIR) Spectroscopy is one such method used to identify organic and inorganic materials in a plastic sample, ensuring the material's composition aligns with its intended use. This commitment to testing not only supports regulatory compliance but also enhances the reliability and reputation of plastic products across diverse industries.
Plastic Materials and Products
Plastic materials are the backbone of countless consumer products, electronics, and packaging solutions. The choice of plastic—such as polyethylene, polypropylene, polyvinyl chloride (PVC), or polyethylene terephthalate (PET)—depends on the specific durability, performance, and safety requirements of the end product. Manufacturing processes like injection molding, extrusion, and blow molding allow for the creation of a wide variety of plastic products, each tailored to its application. To ensure these products meet the highest standards, manufacturers rely on rigorous testing methods, including differential scanning calorimetry and Fourier Transform Infrared (FTIR) spectroscopy. These advanced analyses help verify the material’s composition, thermal behavior, and overall quality, ensuring that plastic products are safe, durable, and perform as expected in their intended environments.
Regulatory Landscape for PETG
Navigating the regulatory landscape for PETG and other plastics is essential for manufacturers aiming to bring safe and compliant products to market. In the United States, the Toxic Substances Control Act (TSCA) regulates the use of certain toxic chemicals in the manufacture of plastic products, while the Food and Drug Administration (FDA) oversees plastics used in food packaging to ensure they are safe for food contact. For electronic devices, the Restriction of Hazardous Substances (RoHS) Directive limits the presence of hazardous substances such as lead and cadmium. Manufacturers must work closely with certification services to verify that their PETG and other plastic products meet these stringent requirements. By ensuring compliance with these regulations, companies can protect consumers, maintain product quality, and avoid costly recalls or legal issues.
Performance Testing Protocols
Performance testing protocols are designed to assess the key properties of plastics, ensuring they are fit for purpose in demanding applications. These protocols include tests for tensile strength, impact resistance, thermal stability, and chemical resistance, each tailored to the specific requirements of the product’s intended use. For example, plastics used in food packaging must undergo rigorous testing to confirm they are safe for food contact and do not leach harmful substances. Similarly, plastics in electronic devices must meet strict standards for electrical insulation and thermal performance. By adhering to established testing protocols, manufacturers can confidently determine that their plastic products meet quality and performance benchmarks, providing assurance to both regulators and end users.
Compliance Testing and Certification
Compliance testing and certification are critical steps in ensuring that plastic products meet all relevant regulatory and quality standards. Through comprehensive testing, manufacturers can identify and quantify restricted substances such as lead, cadmium, and phthalates, ensuring their products comply with regulations like RoHS and TSCA. Certification services, including those provided by third-party organizations, offer independent verification that products comply with federal regulations and industry-specific requirements. This process not only helps manufacturers reduce the risk of non-compliance but also builds consumer trust and supports market access. For companies seeking guidance, a free consultation with a testing and certification expert can provide valuable insights into the specific requirements for their products, helping them achieve compliance and maintain high standards of safety and performance.