Need for Sterilization – a Consideration for Medical Devices

Chemically inert and thermally resistant, fluoropolymer films can be sterilized to extend the lifetime of a device or component while keeping it safe and reliable. When incorporating fluoropolymer films as components in products serving medical or healthcare applications such as drug containment, medical liners, or fluid bags, sterilization capability should be a design consideration. Sterilization methods can often involve repeated exposure to harsh conditions which can impact film performance properties. The choice of an optimum sterilization method can extend the life of the film or component even when subjected to harsh sterilization procedures.

Fluoropolymer Films as a Choice for Various Sterilization Methods

The high melting temperatures and thermal stability of fluoropolymer films make them excellent candidates for autoclave sterilization under heat, humidity, and pressure. The excellent chemical resistance of fluoropolymers allows chemical sterilization methods utilizing bactericidal agents such as ethylene oxide to also work effectively with fluoropolymer films.

Sterilization via ionizing radiation methods such as gamma rays and electron beam offer advantages in terms of time efficiency; however, it is important to consider the effects of radiation on fluoroplastics. Radiation can have two effects on fluoropolymers: chain scission and cross linking. Chain scission results in reduced tensile strength and elongation. Cross linking results in increased tensile strength and stiffness. Both reactions occur simultaneously but one is usually dominant depending upon the particular polymer, radiation dose, and atmosphere. The point at which physical property changes in the film negatively affect device performance-in-use is dependent upon the specific application and should be evaluated within the context of the application. A general guide is that the partially fluorinated fluoropolymers, such as ETFE and ECTFE perform better under radiation sterilization than the fully fluorinated fluoropolymers such as PTFE, PFA, and FEP.  Based on this, a comparative ranking from least to most resistant can be presented as follows: PTFE<PFA<<FEP<<ETFE.

Fluoropolymer Films from Saint-Gobain

Saint-Gobain Composite Solutions are a world leader in the manufacture of high-performance fluoropolymer films for medical, laboratory and pharma applications. We have over 45 years of experience of partnering with the medical industry. Please contact us here to discuss your requirements and product needs – we will be happy to work with you and advise you on your choice depending on your application requirements.