Boosting Trust in Microbiological Testing Data Through GLP

On Oct. 8, 2023, UL Solutions Research Triangle Park Laboratory received accreditation to ISO/IEC 17025, the General Requirements for the Competence of Testing and Calibration Laboratories and Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies, from International Accreditation Service (IAS). 

Enhancing confidence in medical device testing data and processes

Most nonclinical medical devices require formal approval from the United States (U.S.) Food and Drug Administration (FDA) to be sold in U.S. markets. FDA approval requires device manufacturers and developers to demonstrate regulatory compliance and establish devices’ safety and effectiveness. Some medical devices also require third-party certification to achieve compliance with the relevant standards. During third-party certification, an independent, accredited organization tests the products against safety standards without bias.

ISO/IEC 17025 is an international standard that focuses on management, quality and technical competence in undertaking specific tests. Receiving ISO/IEC 17025 accreditation enables UL Solutions to perform third-party services that help boost trust and confidence in nonclinical medical devices, demonstrating that they comply with applicable requirements.

Our services within the scope of ISO/IEC 17025 accreditation include:

• Biocompatibility testing — including cytotoxicity, sensitization and irritation testing

• Chemical characterization — extractable and leachable testing (including material characterization, physicochemical analyses of materials, residue analyses and toxicological risk assessment) to determine the chemical compounds within a product that could possess toxic traits

• Microbial ingress testing — to evaluate the product’s ability to resist or inhibit the transfer of infectious microorganisms under repeated simulated use conditions

• Cleaning validation — to demonstrate the safety of the product after reprocessing and over the entire product lifecycle

GLP principles encompass a quality system of management controls that helps facilities define and standardize processes and conditions to support the consistency, reliability, reproducibility, quality and integrity of medical device safety test data. GLP principles include:

• Standard operating procedures (SOPs) covering all of the testing laboratory’s activities

• Well-trained personnel that follow SOPs and protocol

• Well-maintained and calibrated testing equipment

• Secure records

• Quality assurance for each test and process

The ISO/IEC 17025 accreditation process 

To determine compliance with GLP principles and ISO/IEC 17025 accreditation, an external auditor from IAS conducted a thorough assessment of UL Solutions Research Triangle Park Laboratory and our quality systems and documentation practices. The accreditation involved a series of laboratory assessments and technical reviews, such as reviews of our quality assurance processes, standard operating procedures (SOPs) and laboratory procedural guides (LPGs).

The value of GLP compliance and ISO/IEC 17025 accreditation for UL Solutions customers

UL Solutions Research Triangle Park facility’s ISO/IEC 17025 and GLP accreditation demonstrates our commitment to providing customers with high-quality, traceable, reliable and trustworthy medical device testing data. ISO/IEC 17025 accreditation helps facilitate a wider acceptance of test results and reduce the need for retesting, which can help medical device manufacturers save time and resources. 

As a global safety science leader, UL Solutions uses science-based methodologies to evaluate products for consistency and compliance with global standards and regulations. Our experienced technicians use cutting-edge analytical instrumentation to accurately identify compounds that may leach or be extracted from products.

At UL Solutions microbiological and analytical laboratories, we not only offer nonclinical medical device testing services adhering to GLP principles; we also leverage our diverse domains of expertise to offer comprehensive laboratory and engineering services for medical devices, PPE and a wide variety of other products.

For more information, visit our microbiological and analytical testing page.