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Medical equipment needs to maintain a consistently high level of hygiene at all costs, but these products are often in contact with harmful organisms and dangerous bacteria. Unsterilized medical devices can be used as carriers of disease.

Barrier films and films serve as the first line of defense in a wide range of medical applications, including medical linings, drug seals, and liquid bags.

Regardless of the medical environment, fluoropolymer films are often used as the barrier material of choice. Fluoropolymer films generally provide a range of beneficial properties, making them popular candidates for medical applications. These attributes include:

The best choice of fluoropolymer film may vary according to its end application, but manufacturers usually choose PFA (perfluoroalkoxy polymer), FEP (fluorinated ethylene-propylene), PTFE (polytetrafluoroethylene) Ethylene), ETFE (polyethylene tetrafluoroethylene) or ECTFE (polyvinyl chloride trifluoroethylene).

Each fluoropolymer has the advantages outlined here, so the choice of a medical manufacturer will largely depend on the final application, strength, cost, and any considerations surrounding the manufacturing process.

For example, PTFE film is ideal for applications that require high temperature and chemical resistance. PFA film also has these characteristics, but exists in a transparent form. PFA can also be thermoformed, heat sealed, welded, metalized or laminated to various materials.

FEP film is easy to manufacture and has excellent chemical resistance and mold release properties. They are also very suitable for high temperature and low temperature applications.

ETFE film has excellent weather resistance. It is often used in release applications, but is also very suitable for high and low temperature applications.

ECTFE is resistant to weathering and high-energy radiation, making it a popular fluoropolymer film for the manufacture of lightweight and high-strength composite materials.

Medical device manufacturers should investigate the characteristics of individual barrier film materials to ensure that these materials can meet specific application challenges. However, sterilization should also be considered.

When it is necessary to repeatedly sterilize a medical device coated with a barrier film, the manufacturer must evaluate the long-term performance of the film based on this sterilization situation.

The considerations will vary depending on the sterilization method and the type of fluoropolymer used, which further increases the complexity of the design and manufacturing process.

Fluoropolymer films may be damaged by repeated harsh disinfection, which may cause them to warp or discolor. Understanding the performance of fluoropolymers under different sterilization methods will help manufacturers determine the most suitable film materials for their applications.

Most sterilization methods can be classified as chemical, physical or radiation. Professionals will choose a suitable sterilization method based on many conditions, such as the economics of the process and the number of products to be sterilized.

Physical sterilization is usually carried out in an autoclave. Humidity, heat, and pressure are used to thoroughly clean objects. Most autoclaves take 15 minutes to more than 1 hour to disinfect, depending on the level of cleaning required and the pressure used.

Chemical sterilization uses ethylene oxide (EtO) or chlorine dioxide (CD) gas. Both versions of this process involve cycling equipment through a series of time-consuming steps, including the introduction of chemicals and air cleaning.

Although this method can effectively eliminate many types of bacteria, the use of toxic chemicals and the time required to thoroughly disinfect the equipment make these methods impractical under many operating conditions.

Most fluoropolymer films perform well under chemical sterilization, but the increasing demand to reduce the use of toxic materials is reducing the need for this method.

In recent years, radiation sterilization—especially gamma-ray sterilization—has become more and more popular among users of medical devices and equipment.

This method can see objects exposed to strong gamma radiation sources to kill contaminants. Electron beam sterilization using cathode rays is also a common choice for many users.

Gamma radiation has many advantages over other sterilization methods, especially in terms of time efficiency.

It may become the industry's preferred method, but its disadvantage is that, in addition to being designed to eliminate harmful organisms, radiation sterilization can also adversely affect polymer film coatings.

The exact nature of this problem depends on the coating used, the level of radiation, and many other factors.

The increasing popularity of radiation sterilization (especially gamma rays) has prompted manufacturers to evaluate commonly used fluoropolymer films and evaluate the resistance of each sterilization technique.

High-energy radiation from X-rays, gamma rays, and electron beams has some basic effects on fluoroplastics. It affects elongation, tensile strength, impact resistance and shear strength.

Each polymer responds differently to radiation, and these characteristics, as well as odor and color, may be affected differently.

Polymers usually undergo one of two changes under radiation: fracture or crosslinking.

Polymer fracture can cause damage to toughness and elongation, while cross-linking can increase strength and stiffness.

These two reactions occur simultaneously, but depending on the polymer in question, one of the reactions is more dominant. Contrary to vacuum, these effects are more pronounced at higher temperatures and air.

The radiation dose required to produce these negative effects depends on the polymer, but it may also be affected by residual or functional stress from factors such as design and production, dose rate, product cross-sectional thickness, or absorbed radiation dose.

The polymer's chemical composition, morphology (percent crystallinity), device design (for example, its physical size), and storage environmental conditions after radiation (for example, oxygen atmosphere and temperature) also affect the degradation of the film.

Before the loss of performance, discoloration (usually yellowing) can usually be observed, which indicates a potential problem.

A key challenge in determining the ideal film to use is to understand when the material degenerates to an unusable state.

Industry standards are generally understood as reducing the tensile strength or related parameters by 25% before the material should be discarded.

Fluoroplastic films are classified as "good", "better" or "best" according to their specific performance characteristics.

Partially fluorinated fluoropolymers (such as ETFE and ECTFE) generally perform better under radiation sterilization than perfluorinated polymers (such as PTFE, PFA, and FEP).

The comparative rankings from the most favorable to the most unfavorable are as follows:

Choosing the ideal fluoropolymer film for medical applications depends on many variables, including the sterilization method used.

Choosing the right manufacturer can help extend the life of films and equipment, even when using harsh and repetitive sterilization procedures.

Saint-Gobain Specialty Films can help medical device manufacturers choose the most suitable polymer film for any application.

The company’s engineers have designed and tested each material option, so manufacturers can be confident that their choices are high-quality and well-suited for related applications.

We are a leading multi-material solutions company, focusing on solutions that can achieve better results throughout the industry and in the daily lives of all of us. Using cutting-edge process technology and customer insight, we use a wide range of advanced materials to develop high-performance polymer composites. We manufacture products, develop multi-material solutions or help our customers integrate their systems, regardless of our customers: seeking consistent release and efficiency improvements

nts; build energy-efficient components; want to prevent harmful conditions; maintain the purity of its products or are seeking to design equipment with the highest level of signal integrity.

Saint-Gobain FILMS & FABRICS has a global footprint, with 7 industrial bases and commercial and technical institutions on six continents; we also benefit from Saint-Gobain’s most advanced R&D facilities in France, the United States, China and India, and our film And the specific development capabilities possessed by the fabric manufacturing plant. We use these capabilities to design multi-material solutions that suit your local or global needs in multiple markets and applications to withstand the most extreme conditions.

Composite materials, polymers, multi-materials and engineering

Made from materials originally created by IEEE GlobalSpec.

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Last update: September 17, 2021 at 7:02 am

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