Monthly Archives: February 2012

The Pharma Cold Chain

In the pharmaceutical industry, proper execution of unbroken cold chains can be vitally important. There are many drugs and medications that must be maintained at particular temperatures in order to retain their maximum effectiveness. In storage this is not difficult, but it becomes an issue when transporting such pharmaceuticals to their intended destinations. For example, transporting vaccines to high temperature areas via poorly developed transportation networks can, if not done properly, render them useless. For this reason having the right equipment for your cold chain is vitally important. And today one of the must-haves for effective cold chain logistics is the Timestrip line of time and temperature indicators.

Timestrip makes small compact indicators with temperature sensitive labels that help you keep your temperature controlled transport needs under control. Their line includes four different types of time indicators: Timestrip, TimestripPlus, TimestripMinus and the brand new Timestrip Complete. Timestrip, the first product developed by this company, is a simple indicator that measures elapsed time. For temperature breaches, the Timestrip Plus indicator measures ascending temperature and the Timestrip Minus measures descending temperature. The Timestrip Complete combines both of these features.

Timestrip’s indicators depend on a patent-protected process involving the migration of a dye along a membrane. The indicators are completely inert prior to activation and are stored and shipped at room temperature, which makes them extremely cost effective compared to other cold chain technologies for products that require handling at very specific temperatures. Once the indicator is activated, it begins the measurement and elapsed time or temperature breaches are displayed clearly on its surface. Once activated, these indicators cannot be stopped or turned, making the entire process tamper proof.

The temperature breach indicators TimestripPlus and TimestripMinus are both exceedingly popular in the market. Not only do they tell you that a temperature breach has occurred, but also for how long the product was exposed to unhealthy temperatures. In the case of multiple temperature breaches, they will tell you the duration of each individual breach, as well as the cumulative duration of them all. They are highly accurate and come tailored to a variety of temperature thresholds, so you can choose the best option for the product you need to transport.

Chilled products with thresholds of 5°C, 12°C, 18°C and 23°C and frozen products with thresholds of 0°C and -14°C are all serviceable by the TimestripPlus, while the TimestripMinus is tailored to measure temperature breaches below a threshold of 2°C. And the brand new, groundbreaking Timestrip Complete combines the best of both by measuring temperature breaches outside a given range, both ascending and descending, in order to service the 2–8°C cold chain requirements which are among the most common and that are vital to the pharmaceutical industry. It provides complete, true 2–8°C temperature monitoring in a single product for the first time in the history of the industry.

Other benefits of Timestrip indicators include that they are water resistant, can be stored and shipped at any temperature, are environmentally friendly, have a long shelf life and are extremely cost effective. Whatever you’re pharma transport needs, if you need to keep a close eye on your shipped products, Timestrip UK Limited are definitely the go-to guys for the job.

Cold Chain Logistics and Pharmaceutical Transportation

The term “cold chain” refers to the transportation of pharmaceutical products, active ingredients and biological items in controlled temperature environments. Some sectors where the cold chain mechanism can be used include research, diagnostics and so on. The main objective of using cold chain management during transportation of pharmaceutical goods is to keep the products within a specific temperature range, following the guidelines set in the GMP (Good Manufacturing Practice) by the FDA, as a result, decreasing the cost and increasing efficiency levels.

Specifically Pharma transport follows certain rules during temperature controlled transport. While controlling the temperature, the Mean Kinetic Temperature (MKT) formula is used. The medicines need to be kept between 2 and 8 degrees Celsius. Sometimes in the journey the temperature is allowed to drop to zero degrees and up to 15 degree during storage, shipping and distribution. However the MKT should not exceed 8 degrees.

Sometimes a breach of regulations regarding temperature happens in the cold chain logistics operation. In order to prevent the breach, Timestrip has developed a product named TimestripPlus. This device detects whether or not a product was exposed to a higher temperature during a delivery. Whenever the product is kept outside the specified range during temperature controlled transport, the liquid inside TimestripPlus keeps moving. The liquid stops moving as soon as the product is brought below 8 degrees Celsius. This difference between times can help to decide what actions are needed to be taken. If a person is not sure how long the drug was exposed to the extreme temperature, then one might have no choice other than to dispose of the item. By using TimestripPlus temperature sensitive labels, this problem can be avoided. Vaccine cold chain management is very important as well. There should be some kind of active and passive temperature control system while transporting vaccines.

Managing Cold Chain Temperature in the “Last Mile”

The Cold chain is a part of the overall supply chain procedure. It is used in the production, distribution and storage of products in order to keep the basic characteristics of the products intact. Cold chain actually provides a level of control over the temperature under which pharmaceuticals and other products won’t lose their associated value.

Most of the time, pharmaceuticals are transported using cold chain technology. Sometimes only a couple of batches get manufactured each year. The process of manufacturing is long and complex as well. Sometimes these products have very limited supply and source. It takes many years of research and investment to produce these products, as a result, the cost is high and yield is low. However, sometimes these valuable products get damaged due to some risks involved in the “last mile” of the supply chain.

Here “last mile” means the point of consumption. Places like homes, hospitals or doctor’s offices. There are a lot of stories of pharmaceuticals being transported very carefully to the point of consumption, and then getting spoiled or damaged when exposed to the home environment.

Even with temperature controlled containers it is difficult to know how the medicines have been handled during transit. Using a temperature monitoring label is very important in order to take action if there is a temperature breach. Passive temperature controlled packaging can be used to serve the same purpose. It involves using some extra protective packaging. Now it is mandatory to show compliance with drug temperature guidelines at every stage of the cold chain process.

In the public health care system, ‘last mile’ means the link between service delivery point and a community health worker. Most of the time the community health worker receives the delivery from service delivery and the established inventory control system controls the frequency and method for their resupply. The logistics cycle ‘last mile’ starts with transportation between resupply point and SDP (service delivery point). After that, there is data collection and resupply calculation phase, and finally, there is order fulfillment. In order to make sure that the vaccines remain usable once delivered, passive temperature controlled packaging and temperature sensitive labels should be used.