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Pharmaceutical & medical


well as fake vials of drugs such as the antiviral agent remdesivir, which is often used as a COVID-19 treatment. With demand for coronavirus


treatments remaining sky-high and systems of oversight struggling to keep pace, there is a risk that counterfeit drugs could cause real damage to global efforts to contain the virus, especially in lower-income nations.


Securing the Supply chain with the right toolS and methodS


Clearly, this is a problem that needs to be tackled straight away. Fortunately, the tools and methods for doing so are already available, and the industry is very familiar with their applications and benefits, meaning it is only a matter of ensuring that these solutions are rolled out as widely and consistently as possible. Elemental analysis has long


been established as one of the most effective methods for identifying and removing fake products from the supply chain, as well as to assess counterfeit medicines that have already been seized to find out where they have come from. Using this method, labs can assess the microbial integrity of drug samples and identify potential signs of contamination, achieving a high degree of precision and sensitivity. This method works by combusting a drug sample at high temperatures, before a gas separation and detection process allows the organic elemental constituents of the pharmaceutical ingredients to be measured by highly efficient and accurate detectors. This allows any impurities and irregularities to be spotted easily. The sample’s carbon content is separated by oxidising it, either by breaking it down via UV/persulfate decomposition, or by combusting it inside a high- temperature furnace. The carbon dioxide gas produced can then be identified using an IR detector for total organic carbon (TOC) analysis. TOC analysis is a highly


effective means of detecting whether or not the sample is


pure and to guarantee its microbial integrity. When combined with the UV/persulfate digestion method, it delivers accurate results cheaply and efficiently, with the added bonus of providing lower detection limits, due to the fact that larger sample sizes can be analysed. Although counterfeiting methods are becoming more advanced, the elemental analysis tools used to tackle them are also becoming more sophisticated in order to keep pace. The newest modern elemental analysers allow carbon, hydrogen, nitrogen, sulphur and oxygen quantities to be analysed and detected within a single unified workflow for even greater insights, with minimal need for manual control or downtime. Additionally, these tools serve


multiple purposes within the pharmaceutical quality assurance process. As well as being used to analyse the purity and legitimacy of a sample, the same method can also be used to check whether the equipment used in pharmaceutical production processes has been properly cleaned, preventing batch cross- contamination. Furthermore, stable isotope analysis can deliver insight into the unique chemical fingerprints found in different batches of seized drugs, allowing criminal forensic teams to trace trafficking routes back to their source. There is no doubt that all these techniques will need to be employed effectively as part of global efforts to bring the pandemic under control. Throughout this difficult time, the world has been depending on drugmakers to provide them with vaccines and medicines needed to overcome this once- in-a-generation health challenge; now that these drugs have arrived, counterfeiters cannot be allowed to undermine the hope and protection that these therapies offer. By investing in the right tools to counter the counterfeiters, the industry will take a major step forward in their efforts to bring this pandemic to an end.


Elementar UK www.elementar.co.uk


Instrumentation Monthly June 2021


Measuring ventilation air flow and pressure at the patient’s side


collaborative effort between Sensirion and Nicolay and is available to ventilator manufacturers as an evaluation kit. Manufacturers are able to integrate the various standardised options into their devices with no development or equipment costs. For medium to large orders, Nicolay can configure and produce custom designs. The two companies have already demonstrated how successfully they


N


work together. Their last joint product is widely used for proximal measurements of inspiratory and expiratory respiratory gas flow rates in order to improve ventilation and adapt to the individual patient’s values at any given time. “Having received many inquiries from ventilator manufacturers about whether we could expand our existing solution to include a pressure sensor, we decided to work on this with our partner Nicolay,” explains Dr. Andreas Alt, sales director Medical at Sensirion. “Nicolay immediately took up the idea and implemented it – and can now offer all versions of our proximal products with an additional pressure sensor.” For this purpose, Nicolay's cable specialists have integrated the pressure sensor physically into the connector cap and on the software side in the evaluation electronics. Ventilator manufacturers can receive an evaluation kit as a sample. They can use it to test the combined solution or even start developing prototypes with it. The first manufacturers to purchase the new solution are already working to incorporate it into their devices. Constant monitoring of respiratory pressure is crucial to both volume-


controlled and pressure- controlled ventilation. With the new solution from Sensirion and Nicolay, pressure measurements are taken and converted into an electrical signal directly at the patient’s side; the pressure signal is then sent to the ventilator electronically. Until now, it has been common practice to tap pressure using a patient-side port, convey it via a tube to the device and measure it inside the ventilator. By comparison, the new product from Nicolay provides improved signal quality and faster signal transit time. It also offers exceptionally reliable measurement values, which can be processed with minimum delay. Furthermore, the signal is transmitted through an existing cable used to measure respiratory gas flow values. The tube for tapping pressure can now be only a few centimetres long and run from the WYE straight to the cap on the flow sensor, where the pressure signal is converted into an electrical signal. This eliminates the need for a long pressure tube running from the patient back to the device. As a result, the solution is easier for care givers to handle because there is a lower risk of getting the wrong tube or getting caught on it when treating the patient. “Tubes that convey air, delay measurement when compared to direct, patient-side proximal pressure measurement,” says Benjamin Fessele, product development at Nicolay. “By measuring pressure and converting the signal within the Nicolay sensor cap, measurement values can be evaluated and processed more quickly, ultimately improving the safety and quality of ventilation. This also leaves space in the ventilator for manufacturers to either add


other features or design a more compact device.” www.sensirion.com


27


ow you can take proximal measurements, not only of respiratory gas flow rates, but also of associated ventilation pressure, in a single solution – this product is the result of a


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