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Temperature-Humidity Item-level monitoring of pharma packaging

               
The problem
In the realm of pharmaceutical manufacturing, temperature and humidity exposure are the primary factors that could make products ineffective and useless. The World Health Organization (WHO) recommends maintaining relative humidity levels around 50% and typical temperature storage conditions of about 15 °C – 25 °C. Temperature sensitive products could spoil, causing high losses and useless costs for the pharma company. Moreover, the slightest deviation in temperature or humidity can cause products such as vaccines, pills and ointments to become ineffective and even harmful to patients.
An item-based quality control is hence required to improve the production, supply and storage chains. Till now however this was not possible due to the high costs of (wired) sensors as well as to their size. As a matter of fact, packaging, like plastic or glass bottle or blisters into a cardboard box, is generally small, so that accommodating a low profile and wireless embedded sensor is a strong challenge.
The customer request to Radio6ense was in this case a low-cost device, suitable to be embedded within the smart packaging to sample the interior temperature and humidity of the drug during the manufacturing procedure. Wired probes are not acceptable since they prevent the mobility of the package as well as are way too bulky and have limited life before recharging. Wireless sensors are hence mandatory.




Our solution
In collaboration with a world leader company in big pharma, RADIO6ENSE developed a custom platform based on a battery-less [CS1] wireless sensor. Our solution has no onboard battery, is flexible to adapt to any drug package and is capable to simultaneously measure the temperature and humidity of the packaging. It also permits to identify and track the drug package, like small bottles, during the manufacturing and storage chains.
The energy required to activate and power each sensor is provided from remote by an external reader compliant with the UHF RFID communication protocols. Thanks to its batteryless approach, the sensor can be low-cost and hence usable at item-level.
The wireless sensor was coated by a soft but resistant polymer and is indefinitely reusable with no need to recharge. The collected physical parameters are then integrated in RADIO6ENSE data analysis and visualization tools.
Expected Benefits
Pharmaceutical industries need to guarantee for drug safety: by monitoring the environmental features to which the drug is exposed throughout the production and supply chain (not only roughly, but at item-level), it is possible to reduce costs and increase profits without sacrificing quality.
The smart monitoring of packaging can also make the packaging design easier. Indeed, around 65% of humidity ingress can be attributed to the packaging and therefore the choice of the packaging is critical in maintaining optimal environmental conditions to the drug.
When choosing packaging, material datasheets provide parameters evaluated in very specific and ideal conditions, which cannot be transferred to a specific packaging. Therefore, data detection and analysis in realistic condition on the actual packaging is helpful to avoid unnecessary usability tests.
Embedding advanced features into packaging makes it “smart” and provides significant functionality, thus reducing supply chain losses and increasing transparency, integrity, control and safety at any stage of the supply chain. This is of fundamental importance for example for the supply chain of vaccines, in order to maintain the effectiveness from the manufacturer to the customers.
The IoT technologies for smart packaging provide also anti-tampering/anti-counterfeiting functions, as well as product tracking for smart waste management for improving the circular economy and decreasing pollution.

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