Cold comfort

The system, which can be calibrated to monitor products stored at ambient temperatures, as well as stock in transit, is available on a pay as you go basis based on the number of units monitored. 

With regulatory authorities increasing site inspections following the pandemic, pharmacies should be considering automatic monitoring, mapping, calibration and validation solutions to ensure fridges and freezers are fit for purpose, says Marcus Stacey-Bradbury, UK commercial director of the Ellab Group. “Any extra responsibilities can be a headache for pharmacists, who are busy enough dispensing medicines for customers,” he says. “However, there is no hiding place from a visit by an MHRA or CQC inspector looking for a chink in procedures that could put the public at risk.

“Pharmacies may be creaking under the increasing usage of their services, but hard-pressed staff are still being taken from key duties during an audit to check fridge temperatures, often scrambling around for hand-held thermometers and pens to record the data, which cannot guarantee accuracy.”

The latest mapping, calibration, validation and monitoring solutions can relieve pressure on pharmacy teams by making it easier to identify optimum conditions necessary to meet the standards set for drugs storage. Manual checking can be affected by human error, and pharmacy fridge and freezer doors can be left open, resulting in fluctuations in the mean kinetic temperature (MKT) and products being stored outside of temperature parameters. 

Mr Stacey-Bradbury says pharmacies should not rely on validated warehouses and shipping in refrigerated vehicles. “When boxes reach the pharmacy, they might be left at the door for hours before a pharmacy dispenses or delivers to people that are housebound, which means drugs cycling through a range of temperatures. It’s essential they are moved as quickly as possible to a properly calibrated and monitored storage area, such as specialist refrigerators.”

Ensuring medicines are fit for purpose

Pharmacies have a responsibility to supply drugs that are fit for purpose and within the parameters that manufacturers have set. This is where new technology comes into its own – by qualifying protocols and executing them. Documenting the process ensures safety and accurate data and can also highlight any weak links.

Niall Balfour, chief executive officer at Tower Cold Chain, says: “Mass vaccination programmes are the public health achievements of the contemporary world and efficient cold chain management is a key part of this success. The Covid-19 vaccine rollout demanded specialist end-to-end supply chain requirements, from manufacture, storage and transportation to healthcare and pharmacy facilities. With community vaccination centres constructed overnight to cope with demand, an efficient and resilient supply chain which assisted with temperature-controlled technologies became imperative.”

Mr Balfour believes the pandemic highlighted the need for preparedness for distribution, with transport corridors and hub networks becoming a focus for logistics providers. 

For specialist packaging providers, innovation played a huge role in meeting the growing trend for smaller shipments after the pandemic, such as direct-to-patient, sample shipment, and last-mile deliveries. “It became clear that the pharmacy market would welcome a smaller solution which offers the same robust, reliable, and reusable benefits, but at a size ideal for manual handling,” Mr Balfour says. “Hence, the Tower KTEvolution – with its patent pending design striking the optimum balance between high performance, durability, and optimised weight.” 

The KTEvolution is said to be ideal for the transportation of life science products, including vaccines, diagnostic kits, biopharmaceuticals, samples and solutions, clinical trial kits and any other product requiring a stable temperature environment for transportation. 

Labcold says it is currently experiencing very high demand for ‘all things pharmacy’. Its Advanced Pharmacy refrigeration range is made from stainless steel. Available in 150, 650 and 1,300 litre capacities, it is designed with a choice of solid or glass doors. All models feature door locks, digital temperature display, high/low and door alarms with min/max recording, interior light and auto defrost, and either fan or ducted air flow to ensure there are no hot or cold spots. Remote alarm contacts and an access port are optional.

Intellicold Pharmacy Refrigeration models range from 36 to 543 litre capacity. All offer the choice of glass or solid doors and use the Labcold-designed IntelliCold touch screen controller.

These refrigerators have fan assisted cooling, off cycle auto defrost, remote alarm contacts, access ports, interior lights, controller battery back-up, mains fail, door open and high and low temperature alarm with min/max recording and 24/7 data recording which can be downloaded to a computer via a micro SD card. They are also fitted with a secondary (wandering) probe which can be placed anywhere within the refrigerator or as a load probe in product packaging. The main probe records the air temperature, giving the user time to react before the load temperature is affected.

The Labcold range also includes two vaccine carriers of 12 and 19 litre capacity that use Peltier cooling so there is
no refrigerant gas used. These can be plugged into a car’s 12 volt socket as well as into the mains, making them ideal for community vaccinators.