Temperature excursions in transit damage pharmaceuticals, wasting time and money and jeopardising patients. Amanda Headlee, business project program manager, Almac Group explains how single-source temperature monitoring helps to guarantee the viability of products by enabling effective risk mitigation strategies.
Increasingly sensitive and sophisticated pharmaceuticals and the proliferation of new regulations have made temperature control a hot topic. Even slight deviations outside narrow parameters can waste materials and time, and damage profits. These issues raise concerns within pharmaceutical companies as well as with regulators, as they can add up to a negative effect on patient safety.
While patient safety is of paramount importance for any drug manufacturer, costs and time must be kept in check, as loss of either will spell disaster for any study. Strategies must be developed to reduce the impact of temperature excursions experienced in shipments. Putting safeguards in place to decrease risk will help to bring studies in on time, within budget, and more importantly, with no safety concerns for patients.
A shipment might experience a deluge of temperature effects that can impact the stability of a product, leading to temperature excursions that cause the product to become unfit for patient administration, and, ultimately, cause rejection. Discovering that a product has been compromised after arrival costs money and wastes time, threatening the study and patient safety. Steps must therefore be taken to reduce the risk of temperature excursion in transit.
Risk-based strategies must be applied when identifying transportation routes. Air, land and sea freight each experience different variables that can affect temperature. Each has its own risks in regards to cost, climate, time, and storage locations.
"While air freight is the quickest mode of transport, it can experience great fluctuations in temperature and, due to being more expensive, may result in smaller batches of shipments for cost savings," says Heather Bogle, supply chain solutions manager at Almac Group. "A shipment can be relatively temperature controlled within the airport and in the cargo hold of an aircraft, but once the shipment is brought out on to the tarmac, anything can happen.
"The best case is that the shipment is transported directly from the airport into the aircraft. In the worse scenario, the shipment will sit on the tarmac and be exposed directly to the elements (from frigid cold, to blistering heat and torrential rain). Sea freight is cheaper, allowing for larger amounts of product to be shipped.
"This mode takes twice as long as air, however, and shipping solutions are only validated to maintain temperature conditions for a certain number of days. If a shipment is not delivered within that period, phase change materials (PCM) or bricks may have to be replaced manually, which introduces a whole new level of risk."
The transit method must be considered not only in terms of the route to be taken, but also with depots and destination in mind. Drugs originating in Canada, for example, may be shipped in bulk by sea to a depot in Australia for storage, before being dispatched as land-air cargo to a site in New Zealand.
The product will experience a multitude of climate changes and storage locations in between origin and destination. All of this must be taken into account when considering areas of potential risk.
How does one begin to define risk for an apparently endless number of strategies? The best way is to establish a methodology for monitoring temperature-controlled shipment data.
Temperature monitors are a good primary source for data collected in transit. These can provide a plethora of information with accurate readings that correlate exactly to specific dates and times.
This data can then be compared with the transit route and lined up to identify the cause of potential temperature excursions, or to see what went right during the journey. Being able to retrospectively compare temperature and transportation data illuminates risks that can then be mitigated against by a distribution strategy.
Currently, this data is being collected and manually assessed retrospectively, and is spread across different vendors and software applications. The task of analysing temperature data is time-consuming and could delay a study. Single-source monitoring systems are the future of temperature-monitoring technology. These can collate data from all temperature-controlled shipments into one easily readable report that provides an instant analysis. This data is produced rapidly and efficiently, enabling companies to quickly put logistics strategies in place to reduce risk.
A single-source of temperature assessment data also better aligns companies with new regulations concerning patient safety, saving money, time and lives.
Risks cannot be completely eliminated, but they can be mitigated against, and using temperature and shipment data is the first step. The second is to fine-tune the data in the context of product stability.
According to Christi Gimber, director of quality assurance at Almac Group, "It is possible that products are stable outside the labelled storage conditions for limited periods of time at specific temperature ranges. Currently, most quality assurance departments evaluate temperature excursions manually each time an out-of-specification temperature excursion occurs. This process is time- consuming and prone to errors.
"If a system could track all excursions cumulatively for a particular product lot, shipment, or kit to document the product history, as well as hold predetermined excursion allowances based on the product stability, quality assurance could make product quality evaluations more accurately and quicker because the decision-making and justification is done up front.
"For products with appropriate temperature stability profiles, the data can be used to create predetermined allowable excursion criteria and support a more flexible approach to product evaluation.
"This could minimise discarding material that may be viable due to temperature excursions. For example, a product labelled with storage conditions of 2-8°C may actually be stable at 9-15°C for 180 minutes and at temperatures of 15-25°C for 30 minutes before the product is deemed not viable.
"Giving QA groups predetermined and visible criteria for excursion adjudication allows for a robust and justifiable process for product disposition that is based on data and risk to the patient."
The final step in mitigating risk is to ensure that everyone who handles temperature-controlled shipments is adequately trained in proper handling practices. This starts with workers at the site of origin, where the product is packed, to the receiving site, where it is unpacked and stored, and should also cover anyone in between.
Depot staff must be instructed in how to unpack and repack shipments for proper site dispatch, as well as being able to monitor temperature and handle the relevant monitors properly. Sites must be well trained in the immediate unpacking and storage of a temperature-controlled shipment in proper temperature ranges, as well as handling the temperature monitor.. Any mistakes within this process will jeopardise not only the product, but also the temperature data. Your temperature monitor is the window on a temperature-controlled shipment and must be treated with the same care as the product.
Combining the excursion process with temperature and shipment data assessment and proper shipment handling will provide a clean way to mitigate risk within temperature-controlled shipments.
For successful risk mitigation, pharmaceutical companies must be open to new technology. Proactivity in temperature management will enable companies to stay ahead of the competition, as they will be able to prove their compliance with regulations and ensure patient safety by guaranteeing product stability, while saving time and money.