PEN Filament - Polyethylene Naphthalate

FLXR Engineering is a cutting-edge company specialized in the production of high-performance filaments for 3D printing, aimed at regulated environments. Its focus is on the development of advanced materials that meet the most demanding requirements of sectors such as the chemical, pharmaceutical, biotechnological, cosmetic and medical industries. With a strong commitment to innovation, safety and regulatory compliance, FLXR Engineering has established itself as a benchmark in filaments for critical applications, manufactured under strict quality controls and compliant with international standards.

PEN filament (Polyethylene Naphthalate) is specifically designed for high-demand FDM 3D printing applications. It offers an exceptionally smooth surface within the FDM category, enabling effective cleaning and sterilization without additional post-processing, reducing part variability and simplifying process validation. It stands out for its biocompatibility, chemical resistance and long-term stability, making it suitable for applications in contact with cells, blood, food and pharmaceutical products.

Internationally recognized biocompatibility tests have been carried out directly on 3D printed specimens. The material exhibits low levels of extractables and leachables (E&L), as well as excellent wear resistance, supporting its long-term use in regulated applications.

Key features:

• USP <88> Class VI certification: Printed parts have passed the most stringent in vivo biocompatibility standard, validating their suitability for applications in contact with blood and tissues. Final devices may require additional certifications depending on their intended use.
• USP <87> (in vitro) certification: Cytotoxicity tests equivalent to ISO 10993-5, evaluating biological safety without animal testing.
• Extended regulatory compliance: Printed specimens comply with ISO 10993-4/-10, while the base resin complies with ISO 10993-4/-5/-10/-17/-18, FDA 21 CFR 177.1637, EU 10/2011, EC 1935/2004, USP <661.1>, Japanese Food Sanitation Act, RoHS, REACH, BPOG and ADCF.
• ISO Class 8 cleanroom manufacturing: The filament is manufactured and packaged in a controlled environment, ensuring purity, traceability and absence of contaminants.
• Controlled extrusion process: Manufactured exclusively from virgin PEN, eliminating the risk of cross-contamination with other polymers.
• Excellent chemical resistance: High resistance to acids, bases, organic and inorganic solvents, as well as humidity.
• UV barrier properties: The material absorbs UV radiation below 383 nm, protecting contents and maintaining mechanical properties even under UV sterilization.
• Sterilization compatibility: Compatible with autoclave (under selected conditions), gamma, ethylene oxide (EtO), vaporized hydrogen peroxide (VHP) and common disinfectants.

Sterilization status: the standard product is supplied non-sterile. Gamma sterilization is available upon request.

Reliable 3D printing for regulated environments

3D printing with PEN filament addresses one of the greatest challenges in regulated industries such as pharmaceutical, biotechnological or food: process repeatability and validation. Beyond producing a single part, the real value lies in being able to manufacture the same part consistently, without introducing risk or additional complexity.

By eliminating variable elements such as brims, adhesives, additives or post-processing, process variability is significantly reduced and batch-to-batch consistency is improved. PEN printed parts already in real-world use environments are part of workflows where reliability, traceability and reproducibility are critical, demonstrating how 3D printing can become a robust and validatable manufacturing process, not an experiment.

Applications:

PEN filament from FLXR Engineering is ideal for critical and regulated sectors such as pharmaceutical, biotechnological, chemical, cosmetic, medical and food. Key applications include:

• Covers for bioreactors, reactors and filtration systems (single-use or reusable).
• Components for sensors, microfluidic devices and laboratory instrumentation.
• Surgical guides, templates and medical tooling compatible with autoclave.
• Replacement of injection-molded components in PTFE or PPSU for cosmetic and pharmaceutical equipment.

Thanks to its validated biocompatibility, chemical resistance, advanced barrier properties and thermal stability, PEN filament from FLXR Engineering positions itself as a safe, reliable and high-performance solution for 3D printing in highly regulated environments.