Maintain Cold Chain Equipment Safety
While promising new vaccines will hopefully end the coronavirus pandemic, some of these pharmaceutical products pose new logistical challenges for manufacturers, transporters, warehousers and end users. Processes to maintain the uninterrupted series of refrigerated production, storage and distribution activities, along with associated equipment and logistics, which maintain a desired low-temperature range are known as a “cold chain.” Drug compound integrity must be preserved from manufacturing plant departure all the way through the cold chain to the intended patients. This process often involves packaging with dry ice or liquid nitrogen and the use of specialty freezers and refrigeration units.
UL’s decades of advanced technical, regulatory and clinical expertise are reflected in our refrigeration testing innovation. This allows us to help customers manage regulatory and global market access issues and address emerging connected device risks. We help confirm that medical and vaccine storage equipment is safe to deploy for use in an increasingly patient-centric and connected environment, as well as support clients in solving critical health, safety, security, and interoperability challenges.
Our expertise in product safety and performance testing helps to mitigate risk and accelerate getting refrigerated medical and vaccine solutions to market. Our offerings cover critical needs including process auditing, performance material validation, chain of custody, chain of condition, cybersecurity, sanitation, electromagnetic compatibility (EMC) and wireless services.
Safeguard Vaccines Through Testing and Certification Services
UL provides engineering expertise and testing related to predominant vaccine refrigeration and lab equipment standards such as:
- UL 471, the Standard for Commercial Refrigerators and Freezers
- UL/IEC 60335-2-89, the Standard for Particular Requirements for Commercial Refrigerating Appliances with an Incorporated or Remote Refrigerant Unit or Compressor
- IEC 61010-2-011 the Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use
- World Health’s Organization (WHO) Performance, Quality and Safety (PQS)
In addition to providing testing and certification for contemporary refrigeration solutions, we also offer customized assessments for new and emerging technologies in medical and vaccine refrigeration. Our global capabilities allow us to evaluate and create individualized procedures to help ensure your appliance is properly assessed. UL can also create custom reports based on these tests to properly present the data for your unique requirements.
Our knowledge of global standards and regulatory requirements covers many markets, including the United States (US FDA), Brazil (INMETRO), South Korea (MFDS) and the European Union (EU MDD, IVDD and AIMDD).
Our nonprofit affiliate, Underwriters Laboratories, has set more than 1,800 standards and other documents defining security, quality and sustainability through leveraging/the use of/shared partnerships.
IoT Sensor and Thermometer Performance Testing
In the absence of specialty standards for unique temperature considerations and constraints involving both the transport and storage of pharmaceutical and diagnostic products, UL can partner with manufacturers and logistics companies to develop proprietary test protocols. These protocols can then inform downstream supplier testing conformance. Sterilization, packaging/material performance, sensor interoperability, immunity testing, reliability, and data security may also be evaluated.
Additionally, UL field and remote engineers can audit the repeatable process steps involved with vaccine transportation and handoffs from departure to final destination.
Connected Products and Systems Cybersecurity
As massive logistical cold chain processes are set up to distribute millions of vaccines globally, the attack vector for threat actors attempting to disrupt the distribution of the vaccine has increased dramatically. This can affect all segments of the logistics chain, from pharmaceutical companies to connected sensors and hospital grade freezers through to logistics companies.
UL’s cybersecurity expertise can help companies in understanding risks and gaps for their connected products and systems, improving their cybersecurity posture, and demonstrating their security to the supply chain. Offerings that address critical cybersecurity needs include analysis and application of security regulations, frameworks and standards, best practices for product life cycle cybersecurity, product and system security assessments, supply chain security assessments and security validations to the marketplace.
Why UL for Cold Chain Audit and Vaccine Refrigeration Testing?
At UL, we have a deep understanding of the various factors that can compromise medical refrigeration devices and patient safety. UL’s tenured engineers serve on relevant, associated international and consensus standards development committees. We have deep expertise in several engineering disciplines needed for appropriate cold chain technological convergence: biomedical, electrical, wireless/IoT, cybersecurity, process audit, and more.
Our global facilities are comprehensive, and our customizable tests help ensure your refrigerated medical devices are packaged, stored and safe when put into use. Our state-of-the-art facilities include more than 150 UL laboratories for testing and certification worldwide, where we provide tailored testing solutions and leverage software automation to enhance process efficiency, analyze results and reduce testing cycles.