Hospitals and Pharmacies Need to Take Extra Care with Temperature-Sensitive Products
Monitoring temperature-sensitive medicinal products both in transportation and storage is paramount in order to maintain quality and to ensure that high-risk products such as vaccines, blood products and other protein material remain active. Products may pass through multiple handlers, different environments and substandard intermediate storage leading to a breach in the cold chain. If not monitored effectively, the breach will not be noticed and poor temperature control may result in ineffectiveness, contamination and infection. Imagine the costs both in terms of safety, wasted research and replacement goods.
Minimising these costs can be solved by just one call to The IMC Group, formed in 2007 by the amalgamation specialists in industrial measurement and control and damage deterrent equipment, Hanwell Instruments and Lamerholm, respectively.
The IMC Group has a range of environmental monitors ideally suited for pharmaceutical and medical products. Ranging from simple, yet effective adhesive temperature labels to electronic loggers, there.s a solution guaranteed for all transit and storage applications.
Hanwell has developed a range of data loggers that can be included within shipments. The Hornet is a tiny data logger, small enough to fit inside a pill container that can accurately log temperature and humidity levels during transit, while the Transport Logger is a larger instrument which when used together with the Hanwell software complies with the most stringent administrative controls, as laid down in 21 CFR Part 11 (Control of Federal Regulations) by the Food and Drug Administration (FDA).
Unlike most dataloggers on the market, all Hanwell loggers have been designed with calibration very much in mind. The physical construction and software architecture allow multi point calibration to very high precision.
From Lamerholm, the ShockWatch range of temperature-sensitive environmental labels has recently been introduced into the UK. Through their unique design, they provide indisputable visual evidence of exposure to unacceptable temperature levels. Two sets of tamper-proof indicators are available for a wide variety of temperature thresholds. WarmMark uses a proprietary technique to clearly indicate when the item has been exposed to temperatures above a predetermined threshold. There are nine individual WarmMark indicators available with response temperatures of -18ºC. 0ºC, 5ºC, 8ºC, 10ºC, 20ºC, 25ºC, 30ºC and 37ºC. A change in colour shows when the item under test has been exposed to exactly 2ºC above the response temperature. ColdMark, however, activates when exposed to temperatures below a predetermined level and comes in four temperature activation levels: -3ºC, 0ºC, +5ºC and +10ºC. Activation occurs when the product has been exposed to unacceptable temperatures for 30 minutes or more.
As the Medicines and Healthcare products Regulatory Agency (MHRA) enforces strict monitoring policies, it is vital that hospitals and pharmacies ensure there is accurate monitoring and recording of the temperatures in their fridges and freezers. Together, engineers from Hanwell and Lamerholm can provide sound and practical advice on ways to ensure products are kept at the correct temperature, whether on the move or in storage.
