Why it pays to grill your cold chain services supplier

When it comes to ensuring that your cold storage operation and maintenance meets MHRA requirements, it pays to make sure your service supplier knows what they’re doing. Joe Fudge, Instrumentation Service Manager for ABB in the UK, explains some of the key factors you should consider when selecting a supplier of cold chain mapping services.

European Directives 2002/98/EC and 2004/33/EC set standards of quality and safety for the collection and testing of human blood and blood components, whatever their intended purpose, and their processing, storage and distribution when intended for transfusion. Specifically, Directive 2004/33/EC indicates that blood products need to be stored at appropriate temperatures, according to composition and storage requirements.

The Medicines and Healthcare Products Regulatory agency (MHRA) places stringent requirements on the way that cold storage facilities are monitored and maintained in UK hospitals and medical establishments.

In the absence of any auditing procedure by the MHRA to check the capabilities of cold chain mapping and calibration suppliers, the onus is on the user to make sure that their supplier is fully competent to perform the work.

Questioning your supplier about their approach to these areas will help you to get a better picture of their competence to survey your equipment.

A first step is to check that they are ISO 9000 accredited and that they can offer proof of past work where the MHRA audit has been satisfied.

It’s important to make sure your supplier is using the correct equipment with suitable accuracy and stability for the task. All of the test equipment must have a valid calibration and the supplier needs to provide evidence of this for your records.

Temperature Mapping of temperature controlled equipment should be undertaken annually.

A cold chain mapping survey should also be carried out for a sufficient period of time. As a minimum, a survey should last for at least 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.

An expert supplier needs to consider the different control requirements needed for various cold storage methods of pharmaceutical products. A mapping process must take into account that storage units should be capable of maintaining the required temperature in all parts of the asset and recommend that temperatures are monitored and recorded.

The quantity of products needed for storage will also determine the manner in which they are kept. For example, domestic refrigerators may be suitable for low volumes of products, like eye drops, which are less susceptible to the effects of storage in less controlled environments. However, they would not be suitable for high-risk goods as they may not have the precise electronic control to maintain the temperature within the required range of 5°C±3°.

The minimum requirement for monitoring is a calibrated max/min thermometer. In a domestic refrigerator a supplier should ensure these devices are placed within the load or a suitable buffer and positioned so that measurements are not affected by opening and closing of fridge doors (intrusions).

After every survey, a supplier will hand the customer a detailed report. The quality of this is usually a good indicator of supplier competency. This document will be your evidence to an inspector that you took every reasonable step to comply.

These are just some of the key factors that need to be considered. As a responsible and experienced supplier of temperature mapping and calibration services, ABB can advise on everything you need to do to meet MHRA expectations. For more information, please email customerservice.uk@gb.abb.com or call 01480 488080, ref. ‘cold chain services’.


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