#Japan #3D Printing #Tokyo #PEN Natural #Japan 3D Printer

Introduction

Japan 3D Printer Co., known for its innovative digital solutions, has announced the launch of "PEN Natural", a high-performance filament designed to meet the stringent safety standards required in the medical, food, and chemical industries. This new material not only satisfies raw material certification but also proves the safety of the printed objects themselves, bridging a significant gap in traditional 3D printing processes.

Breaking New Ground

The manufacturing sector, particularly in sensitive areas such as healthcare and food production, has faced challenges adopting 3D printing technologies due to the complexities of proving the safety of final products. While raw materials like pellets may have certifications, these do not automatically guarantee the same safety for the printed objects, which undergo different processes during production.

The launch of "PEN Natural" represents a paradigm shift. This filament has passed rigorous certification tests applied to actual 3D printed test specimens, ensuring it meets safety standards set forth by organizations such as USP (United States Pharmacopeia) and ISO. By confirming the safety of the final product, users can confidently explore its application in end products and tooling for various demanding environments.

Key Features of PEN Natural

1. Compliance with Strict International Standards - "PEN Natural" has been verified for compatibility with several important regulations, including:
- USP <88> Class VI (Biocompatibility testing)
- USP <87> (Cytotoxicity testing)
- ISO 10993-4 (Blood compatibility) and 10993-10 (Irritation and sensitization)
- FDA 21 CFR 177.1637 (Food contact)
- Compliance with Japan’s Food Sanitation Act.

2. Outstanding Purity and Safety - Utilizing a biotechnological manufacturing process without the use of additives and antioxidants, "PEN Natural" features an exceptionally low extractability rating of 0.4 mg/m². This ensures high biocompatibility suitable for up to 24 hours of skin and tissue contact, along with indirect blood contact.

3. Excellent Chemical and Thermal Resistance - The filament exhibits high resistance to acids, bases, and organic solvents. It retains dimensional stability even after undergoing sterilization processes like autoclaving, ethylene oxide (EtO), gamma radiation, or electron beam treatments, making it suitable for environments requiring frequent cleaning and sterilization.

4. Superior Transparency and Visibility - Being a semi-transparent material, it allows users to visually monitor the flow of liquids and meniscus levels within microfluidic devices and chemical storage tanks, enhancing operational oversight.

Potential Applications

The versatility of "PEN Natural" opens up possibilities for several industries:

• - Bio-Medical Sector: Utilization in microfluidic chips, surgical guides, and bone cement molds.
• - Food Industry: Components for food processing equipment, fixtures on production lines, and robotic hands.
• - Chemical Industry: Ideal for chemical tanks, lab instruments requiring chemical resistance, and disposable nozzles.

Product Overview

• - Product Name: FLXR Engineering PEN Natural
• - Model Number: KN-R16-1K
• - Weight: 1 kg
• - Color: Natural (semi-transparent)
• - Compatible Raise3D Models: Raise3D E2, Pro2 series, Pro3 series, Pro3 HS series, E3
• - Additional Info: A dedicated profile (bin file) is available, enabling immediate high-quality printing.

About Japan 3D Printer Co.

Japan 3D Printer Co. is committed to pushing the boundaries of 3D printing technology, providing solutions that cater to various industrial applications since its establishment in October 2013. With headquarters in Chuo, Tokyo, the company aims to enhance the adoption of advanced 3D printing in various sectors.

For further details, visit the official product page.