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Pharmaceutical Manufacturing and Packing Sourcer

Temperature Map Reading

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 at ABB Instrumentation talks to PMPS about some of the key factors to consider when selecting a supplier of cold chain mapping services

Is there any European legislation that might affect UK mapping requirements?

There is some legislation that affects the storage and distribution of blood products in the UK. 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 (Article 5 and Annex IV), and that this must be ‘validated’ (Article 8). The only way to ‘validate’ a blood fridge is to make certain that all parts of it comply with the legal temperature requirements, which requires a proficient thermal mapping process. These European directives were enshrined into UK law in 2005, through the Blood Safety & Quality Regulations (SI 2005/50).

What are the current UK standards associated with cold chain mapping?

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. All designated blood bank fridges must comply with appropriate standards, and all hospitals can be subject to an MHRA audit to ensure they comply.

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 in performing the work. However, despite taking every effort to comply with the MHRA expectations, many hospitals and medical establishments throughout the UK have suffered ‘deficiencies’ during an audit, with many cases directly attributable to their supplier lacking the skills and resources to do the job properly.

How can you ensure you pick the right supplier?

The best advice is to get to know your supplier. There are a number of key areas where errors are frequently made. Questioning your supplier about their approach to these areas will help you to get a better picture of their competence to survey your equipment.

What are the key tasks an expert supplier should be performing?

The 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 – can they offer customer references? It is 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. Another key consideration during the mapping process is to ensure the correct number of probes are used for the size of the fridge being measured. MHRA expectations are that the number of probes used must be scientifically justified with guidance recommending a minimum of three probes for small, conventional size units, and up to 18 or more for very large walk-in facilities.

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. 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 thermal uniformity to be obtained.

An expert supplier should be aware of other factors that can affect fridge mapping. In particular, usage of the plant during the testing process, such as loading it with warm samples for example, can distort the results and show variations in temperature that might not otherwise have occurred. These factors should be noted and detailed in the supplier’s final report, together with data on the loading of the cold chain asset before the start of the mapping survey. The ambient temperature should be within the World Health Organization guidelines.

Will the size of cold storage facilities affect the mapping process?

Yes. An expert supplier needs to consider the different control requirements needed for various cold storage methods of pharmaceutical products. For example, some blood products for biotechnology should be stored at freezing temperatures of -5°C or even below -30°C. 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 recommends 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 not as 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°.

Is there a best practice for monitoring refrigerated products?

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 the opening and closing of fridge doors (intrusions). Care should also be taken not to place goods next to or in contact with the chiller plate or coil, as this could reduce their temperature and have an impact on product quality.

For high-risk products in particular, monitoring should be performed using electronic thermometers with an accuracy of at least ±0.5°C, with the temperature preferably being readable from outside of the refrigerator. If mains-powered, these devices should also include a battery backup to ensure continued traceability of product temperature in the event of a power failure. Though it is recommended for all cold storage facilities, a power failure alarm is especially important for high-risk products.

What should you expect after the survey is completed?

After every survey, a supplier will have to give 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. You should therefore ensure that it contains details on all aspects of the survey, including details of the supplier’s test equipment and a full description of the testing process.

What equipment should an expert supplier be using in a cold chain mapping survey?

Video data recorders can collect a wealth of mapping data, which can be compiled quickly into a detailed postsurvey report. You should check that the recorder is compliant with FDA’s CFR 21 Part 11 requirements for secure electronic data storage. Such protective measures can eliminate the risk of unauthorised data tampering both during recording and the post-recording data gathering stage. Standard security features include the ability to configure and allocate multiple users with individual password and access rights, or an internal security switch protected by a tamper-proof seal preventing unauthorised personnel from altering the recorder configuration.

You can further protect data integrity by ensuring the data recorders are protected by an internal audit trail. This logs any configuration changes made and records who made the changes and when, as well as the details of all data files created and many other events key to process data security, such as calibration changes.

What advice would you give to businesses looking to maintain high standards between mapping surveys?

Large refrigerators (in excess of 6m3) and walk-in cold rooms used in high volume operations should be fitted with an electronic temperature recording device that measures load temperatures. With high volumes, it is important that the chart, printout or direct reading should be checked daily and the examination recorded. In this instance it may be easier to install an electronic recorder, with a calibrated max/min thermometer placed inside the unit as a backup. In large storage facilities, recording probes should be placed within the load for routine monitoring, and if air distribution is not fan-assisted, the probe should be located in the part of the load where low temperatures pose the highest risk.

The placement of goods within walk-in units is also critical. Any goods sensitive to temperatures greater than 8°C should not be stored next to the door and goods susceptible to temperatures below 2°C should not be placed in the airflow of the refrigeration unit. With high risk products it is important that temperatures are recorded on a daily basis and that probe(s) are placed within the load (or within a suitable buffer) to record the load rather than the air temperature. These facilities should also be based in an external environment where the ambient temperature does not affect the temperature control within the unit.

A small but increasing number of blood and biotechnology products must be stored frozen (cyropreservation). Storage units must be capable of maintaining the required temperature in all parts of the load, and temperatures should be monitored within the load and recorded daily.

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Joe Fudge is the Service Manager for ABB Instrumentation, and oversees the service and repair of flow meters, recording and control products and analytical instruments. He has considerable experience of the service business, having started as an apprentice with ABB in 1992. Following the completion of his apprenticeship, he progressed quickly within the company towards his current position. He was later appointed leader of the repairs team, a success that lead to him managing the teams across all three ABB repairs sites.
Joe Fudge
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