On December 3rd, Suzuyo announced that it had obtained accreditation under the international standard ISO/IEC 17025:2017 (an international standard that certifies the technical capabilities of testing and calibration laboratories) on November 10th for protein quantitative analysis testing, which is used to evaluate the cleaning performance of medical devices, at its Suzuyo Gotemba Plant, part of its new medical services business preparation office.
<Certificate Award Ceremony>
This has enabled the company to provide highly reliable quantitative protein analysis services that comply with international standards.
In addition to logistics operations for medical devices, Suzuyo also undertakes manufacturing processes for medical devices from various manufacturers and distributors. The main contracted services include cleaning, primary packaging, and application of legally required labels for medical devices. In particular, the Suzuyo Gotemba Plant, part of the New Medical Services Business Preparation Office, possesses cleaning facilities capable of handling a wide variety of medical devices, enabling them to conduct highly reliable cleaning operations and evaluations.
The initiative stems from the importance of ensuring safety in the cleaning process of medical devices. After use, medical devices can become contaminated with proteins from bodily fluids, creating a risk of bacterial and other microorganisms multiplying using these proteins as nutrients. Therefore, the reliability of the cleaning process is extremely important.
To safely reuse medical devices, it is necessary to quantitatively evaluate and control the quality of the entire cleaning process, including cleaning methods, equipment, and cleaning agents. In particular, the presence or absence of protein residue is an important indicator of cleaning quality, and appropriate measurement and evaluation are essential. This test was certified because it can also be used to evaluate the effectiveness of the manufacturing process (cleaning) of single-use medical devices being developed by the company's Suzuyo Gotemba Plant, which is part of its new medical services business preparation office.
The certification covers two protein analysis techniques compliant with ISO 15883: the BCA method (bicinchoninic acid method) and the OPA method (using orthophthalaldehyde).
<Certificate of Recognition>
■ ISO/IEC 17025:2017 Certification Overview
Content: Testing and calibration laboratories possess "technical capabilities" and "quality control systems".
International standards for proving
Testing facility: Suzuyo Suzuyo Gotemba Plant
Location: 3-13 Jinba, Gotemba City, Shizuoka Prefecture
Certification number: 129935
Certification Number: L25-812
Certification date: July 2025, 11
Accreditation body: Perry Johnson Laboratory Accreditation Inc. (PJLA)
