PROCUREMENT
Temperature mapping Why quality matters for quality management
Although the annual temperature mapping of blood product storage equipment is often regarded as ‘just’ a regulatory requirement, Michelle Rogers of Labcold and Kane Edgeworth of Biomap discuss why temperature mapping should be seen as an essential part of continuous quality management.
he Blood Safety and Quality Regulations 2005 introduced the need for all blood establishments and hospital blood banks to operate a quality management system simi- lar to GMP for the pharmaceutical industry. As a result it became mandatory for blood banks to be temperature mapped before they are used and annually thereafter. This forms part of the PQ and OQ management vital to ensure that temperature sensitive blood products are stored correctly and are safe for patient use.
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With the requirement of blood transfusion departments and processing facilities to file annual reports with the MHRA, temperature mapping could be viewed as an inconvenient extra expense at a time when budgets are in- creasingly tighter and personnel stretched. The temptation could be to find the cheap- est provider; the lowest cost solution, which could compromise quality and create addi- tional costs in the future.
A safe supply of blood is vital to the day-to- day operation of any hospital. Without it procedures could be cancelled. Like anything that is for use inside a patient, the quality of the product must be the best it possibly can which means careful storage is essential in order for the product to be safe and viable.
There are stringent regulations surround- ing the temperature at which various blood products have to be stored and all fridges, freezers, incubators used for red cells, plas- ma and platelets are required to work within strict parameters. Air alarms are fitted to warn of possible temperature incursions and dummy loads are monitored so the ac- tual temperature of the product is recorded. However, if the fridge or freezer is not cor- rectly calibrated or there are hot or cold spots, this could affect the stored product.
Under the MHRA regulations, the storage system needs to be mapped for at least 24 hours to detect any anomalies and prove cal- ibration. But is this really long enough? The temperature and performance of a fridge or freezer is affected by ambient temperature, how often and how long the door is open and the level of stock. If the unit is mapped on a day when not very much happens it may perform faultlessly, but what would happen
if it was put under stress? For a quality man- agement system to work it is vital to know exactly what is happening to a fridge, freezer or incubator and for this, a mapping time longer than 24 hours is absolutely crucial.
24 hours is simply just not long enough to fully understand what is happening inside the storage device. We would recommend a unit is mapped for a minimum of three days because only then is it possible to ensure the unit performs correctly under a variety of conditions. Many large blood banks have two compressors. A 24 hour map would fully capture one, but only partially capture the second refrigeration system. Obviously, it is essential to know how both systems perform because one of them will be solely responsi- ble for storing product in optimum condi- tion for up to 16 hours in any 24 hour period.
The Blood Safety and Quality Regulations apply to blood establishments and to hospital blood banks. The 2006 Amendment Regulations introduce requirements for a quality system in blood establishments and hospital blood banks. They also extend traceability and record-keeping requirements to “facilities” which may receive blood and blood components (care homes, independent clinics, hospitals and other NHS facilities and services, manufacturers of medicines and medical devices and biomedical research institutes).
www.mhra.gov.uk/Howweregulate/ Blood/
index.htm
Longer mapping terms are standard in the pharmaceutical industry and allow for a full profile to capture the impact of door traffic, shift patterns and product being added/ removed. With BSQR regulations designed to mirror the GMP guidelines practiced in the pharmaceutical industry it makes sense to temperature map blood fridges and freezers for longer than 24 hours.
Once units are mapped it is also important that the results are fully understood.
There have been times when a fridge has failed its mapping and the temptation is to either blame the manufacturer or pay out
for costly repairs when it may not be neces- sary. If you study the data in the mapping report and fully understand how it was done and what happened to the unit during that period often it is possible to diagnose what caused the result and ensure that the prob- lem is rectified.
Temperature mapping is a regulatory requirement but when done thoroughly it ensures that quality is monitored and maintained in the both the equipment and product, saving money, saving time and eliminating risk.
Labcold is the UK’s leading specialist manufacturer of professional refrigeration equipment for use in scientific, laboratory and medical applications.
Founded in 1932, Labcold is a privately owned British company with over 40 years’ experience in the supply of professional temperature control products. The full Labcold range, all of which is CE marked, includes blood bank refrigerators; pharmacy fridges;
incubators and monitoring
products. In addition the company has a team of engineers to provide full service and maintenance support.
Biomap works exclusively in the life sciences industry providing temperature monitoring solutions specifically designed to fit with the requirements of cGxP guidelines. Biomap has experience of working with the world’s largest pharmaceutical companies in implementing multi-level temperature qualification services for in-transit and storage applications as well as providing compliant temperature monitoring hardware and software packages.
Michelle Rogers FOR MORE INFORMATION
Labcold T: 0870 300 1001 E:
sales@labcold.com W:
www.labcold.com Biomap T: 0208 748 1039 E:
info@biomap.co.uk W:
www.biomap.co.uk
national health executive Mar/Apr 12 | 65
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