Sterile barrier technology of TPE three-layer composite fabric in medical device packaging

Sterile barrier technology of TPE three-layer composite fabric in medical device packaging

Abstract

This paper aims to explore the application of TPE (thermoplastic elastomer) three-layer composite fabric in medical device packaging and its sterile barrier technology. By a detailed analysis of the physical and chemical properties of TPE materials, production processes and their advantages in medical device packaging, combined with citations from famous foreign literature, the key role of the material in ensuring the sterile state of medical devices is explained. The article also introduces relevant product parameters and technical standards, and provides multiple practical application cases.

Introduction

The safety and effectiveness of medical devices are one of the concerns of the medical industry. To ensure that the medical device remains sterile before use, it is crucial to choose the right packaging material. In recent years, TPE three-layer composite fabrics have gradually become a popular choice in the field of medical device packaging due to their excellent performance and good sterile barrier effects. This article will introduce in detail the characteristics, production process and its application in sterile barrier technology.

1. Basic characteristics of TPE three-layer composite fabric

1. Material composition
   TPE three-layer composite fabric consists of three layers of materials with different functions: the outer layer is polypropylene (PP), the middle layer is thermoplastic elastomer (TPE), and the inner layer is polyethylene (PE). This structural design gives the material excellent mechanical strength, flexibility and sealing properties.

2. Physical Characteristics

   • Density: 0.9-0.95 g/cm³
   • Tension strength: ≥30 MPa
   • Elongation of Break: ≥600%
   • Moisture permeability: ≤0.5 g/m²·24h
   • Breathability: ≤0.1 cm³/m²·24h

3. Chemical Characteristics

   • Chemical resistance: Good tolerance to most acid and alkali solutions
   • Biocompatibility: Comply with ISO 10993 standards and is harmless to human tissues
   • Anti-aging properties: After special treatment, it can maintain stable performance under ultraviolet rays for a long timeDetermined

2. Production process of TPE three-layer composite fabric

1. Raw Material Selection
   High-quality PP, TPE and PE are used as raw materials to ensure good compatibility and adhesion between the various layers of materials.

2. Co-extrusion molding
   Through the co-extrusion process, the three materials are formed into a three-layer composite structure at one time to ensure uniform thickness of each layer.

3. Surface treatment
   Surface treatment of finished products, such as corona or plasma treatment, to improve their printing suitability and adhesive properties.

4. Quality Test
   During the production process, the quality of each process is strictly controlled to ensure that the final product complies with relevant standards and requirements.

3. Application of TPE three-layer composite fabric in sterile barrier technology

1. Sterile barrier system
   TPE three-layer composite fabric can effectively prevent the penetration of microorganisms, particulate matter and gases, forming a reliable sterile barrier. According to the ASTM F1608 standard test, its microbial penetration rate is less than 0.1%, which is far superior to traditional packaging materials.

2. Sterilization adaptability
   The material can withstand a variety of sterilization methods, including ethylene oxide (EO), gamma rays, electron beams and high temperature and autoclave steam sterilization. After multiple sterilization treatments, good physical and chemical properties can still be maintained.

3. Sealing Performance
   TPE three-layer composite fabric has excellent heat sealing performance and can achieve a firm sealing effect at lower temperatures. By adjusting the heat sealing parameters, the needs of different packaging forms can be met, such as bags, rolls and pallet packaging.

IV. Product parameters and technical standards

5. Practical application cases

1. Case 1: Surgical instrument packaging
   A well-known medical device company uses TPE three-layer composite fabric to package its surgical instruments. After long storage and multiple transportation, the product remains sterile and the packaging material has not suffered any damage or deformation.

2. Case 2: Disposable syringe packaging
   A large pharmaceutical company switched its disposable syringe to packaging with TPE three-layer composite fabric. The results show that the material not only improves the sterility guarantee level of the product, but also reduces production costs and enhances market competitiveness.

3. Case 3: Implantable medical device packaging
   Implantable medical devices have extremely strict requirements on packaging materials. An internationally renowned brand chose TPE three-layer composite fabric as its packaging solution, successfully solving the high requirements that traditional materials cannot meet and gained high recognition from customers.

VI. Source of reference

1. ASTM F1608-18, Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System.
2. ISO 10993-1:2018, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process.
3. ASTM D1434-07(2013), Standard Test Method for Determining Gas Leakage Rates and Calculating Gas Permeability of Plastic Film and Sheeting or Other Barrier Materials.
4. ASTM E96-16, Standard Test Methods for Water Vapor Transmission of Materials.
5. ASTM F2029-00(2015), Standard Test Method for Peel Resistance of Thin Films and Foils (T-Peel).
6. Baidu Encyclopedia. “Thermoplastic Elastomers”. https://baike.baidu.com/item/Thermoplastic Elastomers.

Conclusion

TPE three-layer composite fabrics have shown great application potential in the field of medical device packaging with their unique structural design and excellent performance. Especially in terms of sterile barrier technology, this material can effectively prevent the invasion of microorganisms and other contaminants and ensure the safety and effectiveness of medical devices. In the future, with the continuous advancement of technology and the growth of market demand, TPE three-layer composite fabric will surely be widely used in more high-end medical device packaging.

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