Durable coating polymer ZEFFLE MZ for infectants and sterilants of medical devices

Introduction

With the increasing demand for more infection control, the disinfectant and sterilization of medical devices is becoming more powerful, and the degradation of materials used in medical devices is becoming more serious.
To solve this problem, we offer durable coating materials ZEFFLE MZ that are resistant to various disinfectants and sterilants.

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Features

- Excellent chemical resistance (ex. VHP sterilization). As refer to Table.1
- It’s possible to coat on resin parts such as endoscope tube.
- ISO10993 (GLP) biocompatibility test have been passed.
- FDA device masterfile (MAF) has been registered.

Table.1 Chemical resistance of ZEFFLE MZ-100 coating films

*STERRAD^TM 100NX: Evaluation results of STERRAD^TM 100NX

Hydrogen peroxide gas plasma sterilization evaluation

Evaluation

Test was conducted with STERRAD^TM 100NX. The ZEFFLE MZ coating remained intact under hydrogen peroxide gas plasma exposure,while the acrylic urethane coating displayed cracking as shown image 1-2.

- System: STERRAD^TM 100NX
- Hardener: STABiO XD-340N by Mitsui Chemical
- Material: ZEFFLE MZ
- Evaluation cycles: 100 cycles

Image.1 Surface of ZEFFLE MZ coating

No change after 100 cycles

Image.2 Surface of acrylic urethane coating

Film broken after 5 cycles

Vaporized hydrogen peroxide (VHP) evaluation

Evaluation

ZEFFLE MZ coating remained intact under VHP, acrylic urethane coating was blistered as shown image.3-6.

- Company: Santasalo and Steri-Pro Solution Corporation
- System: M100MIX
- Material: ZEFFLE MZ
- VHP concentration: 500ppm
- Evaluation time: 35 days (12hr/day)
- Temperature: 25-30℃
- Humidity: 30%RH, 60%RH

Image.3 Surface of acrylic urethane coating

Image.4 SEM of acrylic urethane coating

Image.5 Surface of ZEFFLE MZ coating

Image.6 SEM of ZEFFLF MZ coating

Customer benefits

Since the disinfectant solution resistance performance of ZEFFLE MZ is very high, excellent chemical resistance characteristics can be imparted by coating materials that are not resistant to hydrogen peroxide gas sterilization and various disinfectants. In addition, since the ZEFFLE MZ does not need to be raised to a high temperature during curing, it is possible to coat general-purpose resins.