Cold key to vaccine rollout

THE MEDICINES and Healthcare products Regulatory Agency (MHRA) is responsible for the controls and authorisations that apply to pharmaceutical storage and distribution, and controls that apply to hospital and pharmaceutical research and development facilities.

The first COVID-19 vaccine to be approved for use and distributed in the UK requires storage at -72°C, from the point of distribution through to transportation and storage at the destination. The challenge throughout is to ensure that the required temperatures are achieved and maintained, with no variations that could render the vaccine ineffective.

Temperature mapping of temperature-controlled equipment should be undertaken annually. ABB started its annual round of mapping at the Jack Copland Centre, headquarters of the Scottish National Blood Transfusion service (SNBTS) in early December. Whilst working through the planned schedule of mapping for blood products, an urgent request was made for additional mapping for -80°C as a priority for the cold storage of the vaccine at the facility.

Over the past five years many medical laboratories have transitioned from the CPA standards to the international standard ISO 15189:2012 Medical laboratories – Requirements for quality and competence. This states that for external services the laboratory shall select and approve suppliers based on their ability to supply the required service in accordance with the laboratory’s requirements. The most effective way to achieve this for cold chain mapping is to select a supplier that is compliant to ISO17025 – General requirements for the competence of testing and calibration laboratories, accreditation for which is issued by UKAS.

Finding a supplier

A first step is to check they are ISO 9001 accredited and can offer proof of past work where the MHRA auditor has been satisfied. Can they offer customer references? Ideally, they should be ISO 17025 accredited by UKAS, and their calibration and measurement capability – as detailed in their schedule of accreditation – should meet the requirements of the laboratory.

Check also that your supplier is using the correct equipment with suitable traceability, accuracy and stability for the task. All the test equipment must have a valid calibration certificate and the supplier needs to provide evidence of this for your records.

A cold chain mapping survey should last for a minimum of 24 hours, with added time for the temperature measurement equipment to stabilise and for a good snapshot of operating efficiency under normal conditions to be achieved. In this respect, it is important to ensure that the logging frequency of the data recording device is properly set, to enable a detailed picture of the equipment’s thermal uniformity to be obtained.

Recording and reporting

Another good indicator of supplier competency is the quality of their survey report. Data should be protected from unauthorised access; safeguarded against tampering or loss and maintained in a manner that ensures the integrity of the data and information therein.

Part of ABB’s mapping toolkit includes advanced videographic data recorders. These devices can collect a wealth of mapping data, which can quickly be compiled into a detailed post-survey report. Compliant with FDA’s CFR21 Part 11 requirements for secure electronic data storage, videographic recorders feature a host of protective measures to eliminate the risk of unauthorised data tampering.

Data integrity is further protected by an internal audit trail, which logs any configuration changes made, together with who made them and when, plus the details of all datafiles created and many other events key to process data security, such as calibration changes.

As a UKAS accredited and experienced supplier of temperature mapping and calibration services, delivering reports through myABB, a personalised web-based channel complementing our service, ABB is well placed to help you meet MHRA expectations.

Dr Jonathan Farrington is technical manager for service at ABB Measurement & Analytics

 https://new.abb.com/uk/service