PEN Filament - Polyethylene Naphthalate

FLXR Engineering is a cutting-edge company specialized in the production of high-quality filaments for 3D printing. Their focus is on providing advanced materials that meet the most demanding requirements of sectors such as chemical, biomedical, cosmetic, and medical industries. With a continuous commitment to innovation and safety, FLXR Engineering has positioned itself as a leader in creating filaments that offer exceptional performance and comply with strict regulatory standards, such as the USP 88 Class VI certifications.

Image 1: The PEN filament stands out for its biocompatibility and chemical resistance. Source: FLXR Engineering.

The PEN filament (Polyethylene Naphthalate) is specifically designed for high-demand 3D printing applications. This material stands out for its biocompatibility and chemical resistance, making it ideal for sectors that require durable and safe products. With the recent certification of USP 88 Class VI, the PEN filament has proven to maintain its biological integrity throughout the printing process, opening new opportunities in medical and food markets.

Notable Features:

• USP 88 Class VI Certification: The PEN filament has obtained the most stringent certification for materials in contact with medical applications, demonstrating that it maintains its biocompatibility during the 3D printing process. It is suitable for applications in contact with human tissues, blood, and implantable devices.
• USP 87 Bioinertia Certification: This validated alternative method for assessing risks in polymers eliminates the need for animal testing. Its in vitro approach ensures the safety of materials for medical and biotechnological applications. It is equivalent to the ISO 10993-5 standard, which also evaluates the cytotoxicity of materials for medical applications.
• Compliance with FDA and USP 87: It also meets the FDA's food contact requirements and USP 87 regulations (in vitro), making it a safe option for the food industry.
• Controlled extrusion process: Manufactured similarly to medical tubing, the filament uses only PEN, eliminating any risk of contamination with other polymers.
• Excellent chemical resistance: PEN is one of the most resistant materials to chemicals, UV radiation, and high humidity levels, making it ideal for demanding industrial and biomedical applications.
• Confirmed biocompatibility: In vivo and in vitro tests validate that the filament is completely biocompatible, making it a reliable option for medical devices and components in contact with tissues.
• Suitable for applications requiring compatibility with autoclave sterilization, gamma, and EtO.

The USP 88 Class VI certification stands as the most demanding standard in in vivo testing, allowing materials to be in contact with blood or implanted in the human body. While final medical devices require specific ISO certifications, meeting this standard is an essential requirement for materials in medical applications.

Table 1: Excellent chemical resistance: PEN offers high resistance to acids, bases, and solvents, making it ideal for industrial and biomedical applications that demand durability against aggressive substances. Source: FLXR Engineering.

Applications:

The PEN filament from FLXR Engineering is ideal for critical sectors such as chemical, biotechnology, cosmetic, medical, and wastewater treatment. Some of its applications include:

• Bioreactor caps, components for sensors and medical devices like surgical guides.
• Used in laboratories, for microfluidic devices and custom parts for instrumentation.

Image 2: Bioreactor caps, reactors, and filters requiring food-grade or USP quality, effective sealing, and autoclave compatibility. Source: FLXR Engineering.

Image 3: Manufacturing of cosmetic equipment: replacement of PTFE or PPSU injection-molded components. Source: FLXR Engineering.

Image 4: Surgical guides and specialized templates requiring USP 88 Class VI certification and autoclave compatibility. Source: FLXR Engineering.

Image 5: Bioreactor caps, reactors, and filters (single-use and reusable). They require food-grade or USP grade, effective sealing, and autoclave compatibility. Source: FLXR Engineering.

This filament is the perfect choice for professionals seeking high-performance materials and regulatory compliance. With its USP 88 Class VI and USP 87 certifications, it ensures biocompatibility and safety during the 3D printing process. It is ideal for demanding applications requiring chemical resistance, advanced barrier properties, and durability under harsh conditions.

The PEN filament from FLXR Engineering stands out for its ability to maintain biological integrity and exceptional functionality during the 3D printing process. Thanks to its biocompatibility, chemical resistance, and advanced barrier properties, this material positions itself as a reliable, safe, and high-performance solution for developing demanding 3D printing projects in critical environments.

Biocompatibility and Sterilization:

This filament is also a very interesting option for medical or biotechnological applications.

Biocompatible parts manufactured typically by SLA, DLP, or MJF technology are generally based on PMMA, which cannot be sterilized by autoclave. Therefore, other sterilization methods are used, such as Ethylene oxide (EtO, a low-temperature option but with health risks and strict safety protocols), Gamma radiation (effective when carefully controlled), or other low-temperature methods like Hydrogen peroxide (H₂O₂) or high-level disinfection with ortho-phthalaldehyde (OPA), which offer gentler alternatives but at a much higher cost.

With PEN filament, we can have a biocompatible and sterilizable material using a highly reliable, accessible, and economical method like autoclave.

Table: Comparison of sterilization methods