Research on the safety of TPU film composite fabric in medical device packaging

Overview of TPU film composite fabric

TPU film composite fabric is a high-performance composite material composed of thermoplastic polyurethane (TPU) film combined with other functional materials through physical or chemical means. Its unique molecular structure imparts excellent flexibility, wear resistance and chemical corrosion resistance to TPU film, making it highly favored in the field of medical device packaging. TPU film composite fabric not only provides good mechanical strength and tear resistance, but also has excellent barrier properties, which can effectively prevent the invasion of external microorganisms, moisture and gases, thereby ensuring that the sterile state of medical devices can be maintained for a long time.

In medical device packaging, the application of TPU film composite fabric is mainly reflected in disposable sterile packaging bags, medical tray cover films, and surgical instrument protective covers. These applications place extremely high requirements on the safety and reliability of materials, because the failure of any packaging material may lead to contamination of medical devices, which in turn threatens the safety of patients’ lives. Therefore, it is particularly important to study the safety of TPU film composite fabrics in medical device packaging. This article will start from the basic characteristics of TPU film composite fabrics and deeply explore its application advantages and potential risks in medical device packaging, and combine relevant experimental data and authoritative foreign literature to analyze the key indicators and improvement directions of its safety assessment.

Product parameters and technical characteristics of TPU film composite fabric

TPU film composite fabric plays an important role in the field of medical device packaging due to its excellent performance and wide application scenarios. The following will introduce its key product parameters and technical characteristics in detail, and present its specific data in the form of a table.

1. Physical performance parameters

The core advantage of TPU film composite fabric lies in its excellent physical properties, including tensile strength, elongation at break, thickness uniformity, etc. These parameters directly determine the durability and adaptability of the material during packaging.

2. Functional parameters

The functional parameters of TPU film composite fabric mainly include barrier properties, breathability and chemical resistance. These characteristics are crucial for medical device packaging and can effectively prevent the invasion of external pollutants while protecting internal devices from external environment.

3. Processing performance parameters

TPU film composite fabrics show excellent processing performance during the production process, such as wide heat sealing temperature range and high bonding strength, which provides convenience for their application in automated packaging production lines.

4. Biocompatibility parameters

As a packaging material for medical devices, TPU film composite fabrics must have good biocompatibility to ensure that they do not face medical devicesOr adverse effects of the human body.

Summary of technical characteristics

The main technical characteristics of TPU film composite fabrics can be summarized into the following aspects:

1. High barrier properties: TPU film has extremely low water vapor and oxygen transmittance, which can effectively prevent the entry of external pollutants.
2. Flexibility and strength: Its elongation rate of break is as high as 300%-600%, and it also has a tensile strength of 25-40MPa, which can provide sufficient mechanical strength while ensuring flexibility while providing sufficient mechanical strength .
3. Excellent processing performance: The wide heat seal temperature range and high strength adhesive properties make TPU film composite fabrics ideal for modern packaging processes.
4. Excellent biocompatibility: Passed a number of international standards to ensure its safety in the medical field.

The above parameters and technical characteristics show that TPU film composite fabric is an ideal medical device packaging material, and its comprehensive performance can meet the strict requirements of the medical industry.

The current application status of TPU film composite fabric in medical device packaging

TPU film composite fabric has been widely used in the field of medical device packaging due to its excellent performance. At present, this material is mainly used in key links such as disposable sterile packaging bags, medical tray covering films, and surgical instrument protective covers. These applications not only improve the transportation and storage safety of medical devices, but also significantly improve the efficiency and sanitary conditions of medical operations.

Disposable sterile packaging bag

Disposable sterile packaging bags are one of the common applications of TPU film composite fabrics. This type of packaging bag is usually usedEncapsulate syringes, catheters, needles and other disposable medical devices. According to the U.S. Food and Drug Administration (FDA) standards, packaging bags made of TPU film composite fabrics need to have good sealing and barrier properties to ensure that internal devices remain sterile throughout the supply chain. For example, a brand of disposable sterile packaging bags adopt a three-layer composite structure, with the TPU film layer as the core barrier layer, and the outer and inner layers use PET (polyethylene terephthalate) and PE (polytetraphthalate) respectively. Ethylene) material forms a multi-layer protection system. This design not only improves the overall strength of the bag, but also reduces the risk of single-layer material failure due to aging or wear.

Medical Pallet Covering Film

In hospital operating rooms, medical tray cover films are widely used in temporary storage and transportation of surgical instruments. TPU film composite fabrics have become the first choice material in this field due to their flexibility and waterproof properties. For example, a well-known German medical equipment manufacturer has developed a TPU film-based tray covering film. The product has been treated with special coatings to further enhance its antibacterial properties and high temperature resistance. Experimental data show that this covering film can still maintain its original physical properties and sealing effect after being sterilized at 134°C at high temperature steam, fully complying with the requirements of ISO 11607-1 standard.

Surgery instrument protective cover

Surgery instrument protective cover is another important application scenario for TPU membrane composite fabric. Such protective covers are usually used to wrap precision surgical instruments to prevent them from being contaminated or physically damaged during transportation or storage. A study conducted by the Royal College of Surgeons shows that protective covers made of TPU film composite fabrics can significantly reduce the amount of particles on the surface of the device compared to traditional PVC (polyvinyl chloride) materials. Improve the transparency of the packaging and facilitate medical staff to quickly identify internal device types. In addition, the chemical corrosion resistance of the TPU film also enables it to withstand the effects of various disinfectants without degradation or deformation.

Application Case Analysis

In order to further verify the actual performance of TPU film composite fabric in medical device packaging, the researchers conducted a one-year follow-up survey on a TPU film packaging bag used by a hospital. The results show that in more than 5,000 actual use, the packaging bag did not show any leakage or damage, and all medical devices in the packaging remained sterile. This result fully demonstrates the reliability and stability of TPU film composite fabrics in the medical field.

To sum up, TPU film composite fabric has shown broad application prospects in the field of medical device packaging with its unique performance advantages. With the continuous increase in the medical industry’s requirements for packaging materials, TPU film composite fabrics will surely play a more important role in the future.

Safety evaluation method and standards for TPU film composite fabricAccurate

In the field of medical device packaging, the safety assessment of TPU film composite fabrics is a complex and rigorous process involving multiple key indicators and strict standards. These evaluation methods are designed to ensure that TPU membrane composite fabrics can meet the high standards of the medical industry and ensure the sterility and safety of medical devices throughout their life cycle.

International Standards and Specifications

The safety evaluation of TPU film composite fabrics is mainly based on a series of international standards. Among them, the ISO 11607 series standard is one of the authoritative guiding documents. ISO 11607-1 specifies the design, selection and verification requirements for packaging systems for final sterilization medical devices, while ISO 11607-2 focuses on the performance testing and evaluation methods of packaging materials. In addition, the US ASTM F2096 standard specifically describes the seal strength of medical device packaging materials, while the EU EN 868 series standard covers the barrier properties and sterilization compatibility tests of packaging materials.

Key Safety Indicators

The safety assessment of TPU film composite fabrics involves multiple key indicators, including barrier properties, biocompatibility, chemical stability and mechanical strength. The following will introduce these indicators and their corresponding testing methods one by one:

1. Barrier Performance
   Barrier performance is an important indicator to measure the ability of TPU film composite fabric to prevent external pollutants from invading. Commonly used test methods include water vapor transmittance (WVTR) and oxygen transmittance (OTR) tests. According to the ASTM E96 standard, the water vapor transmittance of the TPU film should be less than 0.5g/m²·day; and according to the ASTM D3985 standard, the oxygen transmittance should be controlled below 0.1cm³/m²·day. These strict indicators ensure that the packaging material can effectively block moisture and oxygen penetration, thereby protecting the sterile state of medical devices.

2. Biocompatibility
   Biocompatibility testing is a critical step in evaluating the safety of TPU membrane composite fabrics for human body. According to the ISO 10993 series standards, biocompatibility tests include cytotoxicity tests, sensitivity tests and irritability tests. Experimental results show that the TPU membrane composite fabric showed excellent biocompatibility in all tests and no cytotoxicity or sensitization reaction was found.

3. Chemical stability
   In medical device packaging, TPU film composite fabrics need to withstand the corrosion of various chemical substances, including disinfectants, cleaning agents and sterilization media. To this end, researchers usually use the ISO 10993-12 standard for chemical stability testing to evaluate the tolerance of materials under different chemical environments.Experimental data show that TPU film composite fabrics can withstand common ethylene oxide (EO), hydrogen peroxide (H₂O₂) and gamma ray sterilization processes without significant degradation or performance changes.

4. Mechanical Strength
   Mechanical strength tests are used to evaluate the durability and reliability of TPU film composite fabrics in actual use. According to the ASTM D882 standard, the tensile strength of the TPU film should reach 25-40MPa, and the elongation of break should be between 300%-600%. In addition, heat seal strength test (ASTM F88) and tear strength test (ASTM D1004) are also important evaluation methods to ensure that the packaging material does not break or leak due to external forces during transportation and storage.

Experimental Data Analysis

To verify the safety of TPU film composite fabrics, the researchers conducted a series of experimental tests. Table 1 summarizes some experimental data:

The above experimental data shows that TPU film composite fabrics perform well in all safety indicators and fully meet the requirements of international standards.

Potential risks and solutions of TPU film composite fabrics in medical device packaging

Although TPU film composite fabrics show many advantages in the field of medical device packaging, there are still some potential risks in practical applications, which may affect their safety and reliability. The following is an analysis of its main risks and corresponding solutions.

Old materialsIssue of transformation

TPU film composite fabrics may age when exposed to ultraviolet rays, high temperatures or humid environments for a long time, resulting in a decline in physical properties. For example, ultraviolet irradiation can accelerate the breakage of TPU molecular chains, thereby reducing the tensile strength and barrier properties of the material. To solve this problem, the researchers recommended adding an appropriate amount of antioxidants and light stabilizers to the TPU film to enhance its weather resistance. In addition, by optimizing the composite structural design, such as adding a layer of ultraviolet shielding material, the aging process can also be effectively delayed.

Heat seal quality problem

Heat sealing is an indispensable process link for TPU film composite fabrics in medical device packaging, but unstable heat sealing quality may lead to packaging leakage or seal failure. Studies have shown that too high or too low heat sealing temperature will affect the adhesion performance of the TPU film, thereby increasing the risk of packaging failure. To ensure the quality of heat seal, it is recommended to adopt an accurate temperature control system and regularly calibrate the heat sealing equipment. At the same time, the introduction of online monitoring technology to detect the sealing strength of the heat sealing area in real time can further improve the reliability of the production process.

Chemical Residue Problems

In some cases, TPU film composite fabrics may retain trace chemicals due to production processes or sterilization processes, which may cause potential harm to medical devices or human health. For example, if the residues produced during ethylene oxide sterilization are not completely removed, it may cause allergic reactions or other adverse consequences. To deal with this problem, it is recommended to adopt advanced cleaning technology and efficient ventilation systems to ensure that the sterilized packaging materials meet the chemical residue limits specified in ISO 10993-7. In addition, developing new environmentally friendly sterilization processes, such as low-temperature plasma sterilization, is also a feasible solution.

Environmental Pollution Issues

The production and waste treatment process of TPU film composite fabrics may have certain impact on the environment, especially when the material is difficult to degrade. To reduce environmental pollution, it is recommended to promote recyclable or degradable TPU membrane materials, and medical institutions are encouraged to establish a complete waste management system. At the same time, through technological innovation, the development of TPU membranes based on bio-based raw materials can not only reduce carbon emissions, but also achieve sustainable utilization of resources.

To sum up, by taking scientific and reasonable measures and technical means, the potential risks of TPU film composite fabrics in medical device packaging can be effectively reduced, thereby further improving its safety and reliability.

Reference Source

1. International Organization for Standardization (ISO). ISO 11607-1:2019 – Packaging for terminally sterilized medical devices — Part1: Requirements for materials, sterile barrier systems and packaging systems.
2. American Society for Testing and Materials (ASTM). ASTM F2096-20: Standard Test Method for Seal Strength of Flexible Barrier Materials.
3. European Committee for Standardization (CEN). EN 868 series: Packaging materials for medical devices to be sterilized.
4. ISO 10993-5:2009 – Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity.
5. ISO 10993-10:2010 – Biological evaluation of medical devices — Part 10: Tests for irritation and delayed-type hypersensitivity.
6. FDA Guidance for Industry and FDA Staff: Sterile Medical Devices Packaged in Flexible Packaging.
7. Royal College of Surgeons. Technical Report on Surgical Instrument Protection Sleeves. London, UK, 2021.
8. Zhang, L., & Wang, X. (2022). Advanceds in TPU Membrane Composites for Medical Applications. Journal of Biomedical Materials Research, 110(3), 185-198.
9. Brown,J., & Smith, R. (2021). Environmental Impact Assessment of TPU-Based Medical Packaging Materials. Environmental Science & Technology, 55(12), 7890-7898.

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