Rotronic monitors ‘hidden hazards’ in pharma transport

products-servicesRotronic AG
December 14th 2017

 

Overview

Rotronic’s recent release of the high precision single use TL-CC1 cold chain logger that can be used to protect temperature-sensitive items during storage and shipping has heightened awareness of other variables that need to be monitored in transportation.

Fragile goods such as pharmaceutical drugs, vaccines and medical devices also face hazards from incorrect humidity, pressure variations, light and handling shocks. These variables can also be monitored during transportation with specialized logging devices.

Background

A major step in the transportation industry was the international standardization of shipping containers in 1955. This meant it became possible to place goods in a standard dimension container that could be seamlessly shifted from truck to train to ship for transport anywhere in the world.

The current basic building block of container shipping is the 22GP ISO standard 20-foot dry container. It is estimated that some 28 million of these steel boxes are currently in circulation worldwide. Every year, some 10,000 shipping containers are lost at sea, mostly as the result of falling overboard.

Container shipping has slashed the costs of transportation between countries and regions, to the point where the cost of transporting a bottle of Chilean wine to Europe is currently estimated at 0.16 Euro cents, approximately 1/2000th of its wholesale price. However, should that wine bottle become broken or spoiled en route, the shipping cost effectively rises to 100% of the total.

Containerization and the consequent fall in the costs of international and regional shipping is the major factor driving the evolution of the globalized economy, which places ever-greater emphasis on specialization in which industries or regions maintain competitive advantage by focusing on particular expertise and local advantages.

As an example, Cuba’s soils and climate provide brilliant conditions for Corojo and Cirollo tobacco cultivation that form the foundations for the island’s world-leading cigar industry.

A key factor in the protection of tobacco in storage and shipment is maintaining high humidity, hence the emphasis on storing cigars in ‘humidor’ boxes and rooms that maintain ideal moisture to prevent cigars drying out.

Like wine or tobacco, there are many products where special requirements for handling have to be considered in order to maintain freshness, internal integrity, color, solubility, pharmacodynamics or biological properties. Inappropriate warehousing or transportation could affect any of these essential properties.

Transportation hazards

Various factors can have a negative impact on a product during transportation. There are five key parameters that may need to be monitored to ensure end-product quality and protect fragile consignments in transit:

  • Temperature: Controlling temperature is the key in transporting fresh foods, where maintaining lower temperatures reduces the rate of decomposition significantly. It is also important as proof of an uninterrupted cool chain for frozen products or to ensure the effectiveness of medication.
  • Humidity: Monitoring humidity ensures that the growth of microorganisms in food and medications remains below critical levels. Controlling humidity also helps to maintain structural integrity of paper and cardboard or to avoid corrosion of metals during a long transatlantic journey in a shipping container.
  • Pressure: Apart of being able to reconstruct when and how long a parcel`s flight was, pressure is also en essential parameter for products that have to be transported in a vacuum or pressured chamber. This method could for example be used when transporting biological samples or hazardous chemicals.
  • Shock: To establish that expensive machinery, glass, works of art and other delicate products have been effectively protected during transportation, it is necessary to maintain a continuous record of G-forces on the package in all three axis.
  • Light: Light is a good parameter to determine if or at what time a container or package was opened. Also to ensure protection of light sensitive products such as vegetable oils, chemical substances or photo papers.

Rotronic transportation solutions

Rotronic offers a range of probes and sensors that are applicable to transport and storage applications. These include:

  • The TL-CC1 cold chain logger: is an easy to use single-use temperature logger that can be attached to consignments to monitor and record the temperature of sensitive goods during transportation and at exchange points. The TL-CC1 is perfect for pharmaceuticals, food and technical products. This all-in-one solution is freely configurable by user without software installation and features clear alarm identification, tamper protection, automatic PDF report generation and high storage capacity with an 8,000 data point memory. The TL-CC1 conforms to GxP, EN 12830 and FDA 21 CFR Part 11 / GAMP 5 standards.
  • BL-1D: This compact and versatile data logger can measure and record temperature, humidity and pressure simultaneously. With a long battery life and variable logging intervals, the BL-1D is an ideal solution for humidity and temperature measurement applications in server rooms, production areas, shipping, aviation, residential and office rooms.

Resources

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Rotronic TL-CC1 cold chain logger: ensures items are kept at the correct temperature during transportation.

Rotronic TL-CC1 cold chain logger: ensures items are kept at the correct temperature during transportation

Rotronic BL-1D: monitors temperature, humidity and pressure.

Rotronic BL-1D: monitors temperature, humidity and pressure

Cold chain truck shipment: interior of temperature-controlled lorry.

Cold chain truck shipment: interior of temperature-controlled lorry

Tobacco fields in Vinales, Cuba

Tobacco fields in Vinales, Cuba


Supplier Information
Supplier: Rotronic AG
Address: Grindelstrasse 6, CH-8303 Bassersdorf, Switzerland
Tel: +41 44 838 1144
Fax: +41 44 838 1487
Website: http://www.rotronic.com