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Sterile medical packaging is the basic guarantee for the saf
Release: Hexiang Packaging  Time:2021-09-14

Summary of contents: Aseptic medical packaging (sterile barrier system) is a key and inseparable part of sterile medical devices, and is the basic guarantee for the safety of sterile medical devices and doctors and patients. An effective aseptic packaging system is the first line of defense to ensure the safety and effectiveness of medical devices, reduce the occurrence of medical-related infections, and protect the health and life of patients and medical staff. This article outlines the development history of aseptic packaging, the design and production factors in engineering and its future development and prospects, and narrates the key hot spots of aseptic packaging from the perspective of international and domestic industry standards.


About the author: Qin Lei, DuPont Asia Pacific Senior Marketing Technical Specialist


0 Preface


    Sterile medical devices refer to medical devices that are produced and sterilized by the manufacturer and supplied in a sterile state, and the medical unit does not need to be sterilized and used directly. It includes: disposable sterile medical devices and implantable sterile medical devices. From rural primary-level medical units to top-tier hospitals in large cities, sterile instruments are commonly used in the various processes of disease prevention, diagnosis and treatment. They are the most widely used medical instruments that have the most contact with patients. They are in my country’s medical and health insurance. Plays a very important role. Therefore, no matter the product safety quality accident occurs for any reason, its wide coverage, great harm, and long-term social impact are unmatched by any other medical device.


    For the medical industry, HAI is a very serious and important topic. HAI is the abbreviation of Healthcare-associated Infections, which refers to medical-related infections, which are related to many factors. Infections caused by medical devices used in medical operations account for about two-thirds of all infections. The packaging of sterile medical devices is the first line of defense to protect medical devices and prevent infection. Ineffective packaging will threaten the health and lives of patients and medical staff. This article discusses the importance and prospect of sterile medical packaging barrier system for medical devices and HAI from the following points.


1. The international standard of sterile medical packaging and the development course of my country's standard


    Looking back at history, as early as the 1970s, medical device manufacturers have begun to seek packaging that guarantees the safety and efficacy of sterile products, while reducing waste in hospitals and supply chains, and can provide cost-effectiveness for medical reforms. . Safety has become a basic quality. In these years of development, the focus of work has been to improve the safety of the entire sterile barrier medical device packaging industry. In the practice of medical packaging engineering, aspects such as physical properties, sterile barrier properties, stability of aging packaging, easy opening, and material clarity are involved. A lot of effective work by scientists and engineers has made today's packaging stronger, more functional, and cheaper. Sterile barrier medical device packaging is an integral part of a comprehensive and effective medical delivery system. However, from HAI's not optimistic data, we still see that there is still a lot of room for improvement. This requires unified actions by the industry, laws and regulations to ensure the safety and effectiveness of medical products.


    The early standards and regulations before 1993 were numerous, complex and imperfect. The European Medical Device Directives issued in 1993 was a milestone. This regulation has accelerated major changes in the medical device packaging industry, and at the same time, the certification department has begun to certify packaging. The promulgation of the plan, combined with earlier work, effectively promoted the birth of ISO11607, a packaging standard for terminally sterilized medical devices, and the European Committee for Standardization (CEN) packaging standard officially promulgated in 1997. Since then, ISO11607 has evolved into the main global standard for guiding medical device packaging operations. [1]


    ISO11607 contributes to the specification of industry standards, because this is a separate standard; this standard not only contributes to the unified management of all medical device manufacturers (MDMs), but also effectively reduces the unconventional interpretation of standards by certification organizations Appear.


As a continuation of packaging standards, in 1996, the U.S. Food and Drug Administration (hereinafter referred to as FDA) issued its "Quality System Specification" (ie, "QS Regulatory System"), which introduced the concept of design control. The mandatory implementation result of this specification is that packaging must be considered in the process of design control. These standards are independent and related to each other, effectively ensuring the consistency, operability and certification of medical packaging. The release of these standards has enabled the development of aseptic packaging laws and regulations by leaps and bounds.


    ISO11607: 2006 "Packaging of Terminally Sterilized Medical Devices"-Part 1: "Requirements for Materials, Sterile Barrier Systems and Packaging Systems" and Part 2: "Requirements for Confirmation of Molding, Sealing and Assembly Processes" are aseptic medical International standards for packaging. ISO11607 is a landmark document, and it is even more significant today. my country has adopted ISO11607:2003 "Packaging of Terminally Sterilized Medical Devices" and converted it into a national standard, and issued GB/T19633-2005 "Packaging of Terminally Sterilized Medical Devices" on January 24, 2005, May 2005 Implemented on the 1st.


2. Factors affecting the selection of sterile medical packaging materials and packaging design


    The functions of sterile medical packaging mainly include:


(1) Provide microbial barrier and physical protection


(2) Must be suitable for sterilization


(3) Maintain sterility and integrity until it is used


(4) Easy to open and sterile delivery


(5) Identify products, clearly indicate information and warnings


    For the sterile medical device production industry, commonly used sterilization packaging materials are: porous materials (that is, air-permeable materials, such as paper, Tyvek®) and impermeable materials (such as plastic films, etc.). Commonly used packaging forms (sterile barrier systems) include: hard blister boxes, soft blister boxes (FFS packaging), sterile tube bags, head bags, window bags, etc.


    Factors affecting the selection of sterilization packaging materials and packaging design include: specific characteristics of medical devices, expected sterilization methods, expected uses, expiry dates, transportation and storage conditions, etc.


    According to the latest statistics released by the US FDA, 13% of product recalls are caused by packaging problems. Packaging defects are a very important reason for the recall of medical products. According to some packaging failure cases that frequently appear in the domestic market, the following focuses on the issue of sterilization adaptability.




3. Sterile medical packaging must be compatible with the sterilization process


    The so-called sterilization adaptability refers to the characteristics of packaging materials and/or systems that can withstand the sterilization process and achieve the conditions required for sterilization in the final packaging. At present, the most commonly used sterilization methods in the industry include: ethylene oxide (EO), gamma rays, electron beam, steam and low-temperature oxidation sterilization.


   "When medical devices are sterilized by ethylene oxide, steam or low-temperature oxidation, the sterile medical packaging material must have a breathable part" is clearly required by the sterile medical packaging standard. (See ISO11607:2006 "Packaging of Final Medical Devices"-Part 1: "Requirements for Materials, Sterile Barrier Systems and Packaging Systems" Appendix A.2.1).


The main reasons for this requirement are:


(1) Enable the sterilant to enter the medical device packaging to kill microorganisms-to ensure the effective realization of sterilization.


(2) The sterilization gas can be dissipated and analyzed from the package, and the residual concentration can be reduced-to ensure the safety of medical staff and patients.


    Especially in terms of ethylene oxide residues, because it involves the safety of medical devices and doctors and patients, the State Food and Drug Administration has strict requirements for ethylene oxide residues on medical devices that are sterilized by ethylene oxide. And often conduct special supervision and random inspections. Choosing a sterile packaging material with good air permeability and antibacterial properties is very important to ensure the effectiveness and safety of ethylene oxide sterilization.


4. The important role of medical device packaging (sterile barrier system) in the prevention of medical-related infections (HAIs)


    In the past many years, the pressure to reduce medically-associated infections (HAIs) has increased. In the United States alone, these infections cause hospitals to spend billions of dollars on health care each year. Among them, blood tract, urinary tract, respiratory tract and other infections caused by sterile medical devices used in medical operations account for about two-thirds of all infections.


    American literature shows that about 720,000 people were infected with HAI in 2011, and 75,000 of them lost their precious lives. Innovative medical device design, including complete sterilization packaging, storage and logistics technology can minimize HAI. [2]


    For the relevant data of HAI, there is no accurate data due to the lack of statistics and reporting. The following nosocomial infection outbreaks in China can be understood as the harm of HAI.


   (1) In 2006, there were 10 cases of iatrogenic eye infections in the Suzhou Municipal Hospital of Anhui Province who received cataract surgery, and 9 of them had a malignant medical damage event in which a unilateral eyeball was removed.


   (2) In 2008, nosocomial infection occurred in the neonatal department of the First Affiliated Hospital of Xi'an Jiaotong University School of Medicine, and 9 newborns died.


   (3) In 2009, 28 of 58 hemodialysis patients in Anhui Huoshan County Hospital were infected with hepatitis C.


   (4) In 2003, SARS broke out in China, with a total of 5327 patients recorded. The occurrence of SARS has promoted the development of China's public health safety and hospital infection control.


    As the first line of defense against infection, medical packaging (sterile barrier system) is a key factor in preventing medical-related infections. The sterile barrier system must prevent the invasion of microorganisms and at the same time ensure that the medical products inside can be rendered aseptically during use. Therefore, it is very important to choose a packaging material with the strongest degree of protection possible.


5. DuPont™ Tyvek® material provides reliable protection


    DuPont™ Tyvek® is regarded as a high-quality benchmark material for sterile medical packaging. Compared with other porous packaging materials, DuPont™ Tyvek® provides a higher level of sterile protection for medical devices and medical supplies. Its unique structure makes it reach the best balance of antimicrobial penetration, adaptability to various sterilization methods, tear resistance and puncture resistance, and clean and easy peeling properties.


    The specific performance is: excellent microbial barrier performance-even under the harshest conditions in a highly polluted environment, DuPont™ Tyvek® can still maintain a high degree of resistance to bacterial spores and other contaminating microorganisms.


Significantly reduce the risk of packaging rupture—Compared with medical-grade packaging paper, DuPont™ Tyvek® has excellent puncture resistance and tear resistance, which means that if the package has a crack, it will not be easily punctured and the crack will not be easy to continue to expand .


    Sterilization method compatibility—Unlike medical-grade packaging paper and medical film, DuPont™ Tyvek® can be compatible with all the most commonly used sterilization methods. And, no matter what method is used, DuPont™ Tyvek® can maintain its excellent microbial barrier and tear resistance.


    Lower risk of device contamination—The particle generation test compares DuPont™ Tyvek® with medical-grade packaging paper, and it is confirmed that DuPont™ Tyvek® produces aerosol particles that can pollute medical equipment and sterile environments than medical-grade packaging paper. Much less. 

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