medical & pharmaceutical


most prolific producer of fake medicines. The current crisis is leading to a rise in illicit sales of falsified vaccines, as 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


UKManufacturing Autumn 2021


Keeping medical


environments safe, sterile,


and protected


Medical environments must be monitored to the highest levels to ensure complete compliance and safety for staff and end-users. ION Science’s range of fixed PID sensors can measure VOC outputs on multiple large sites or single key areas, using world-leading gas detection technology.


monitoring is sterilisation and packaging. Many medical manufacturers use ethylene oxide for decontamination of products prior to leaving the site. While this is a highly effective method, it is a harmful VOC and needs careful monitoring via PID (photoionisation detection) technology to ensure the right levels are used to remove potential contaminants, but also so that the ethylene oxide is removed safely prior to distribution. For manufacturers that handle large


O


volumes of products or operate across multiple sites, ethylene oxide will be used frequently and at many stages of the manufacturing cycle. This requires not only highly sensitive levels of detection to ensure that the correct levels are being adhered to at particular stages, but also there is a requirement to have many sensors on and around the site so any potentially harmful levels are detected quickly. The Falco fixed fenceline detector


from ION Science, a leading global OEM of gas detection equipment, is ideal for medical applications thanks to its excellent VOC sensitivity, advanced PID technology and large detection range. What makes it especially suitable for medical and pharmaceutical applications is not only this technology, but also ION Science’s in-depth knowledge and experience of the sector. ION Science is currently working


with a global sterilisation and medical equipment specialist to create a complete VOC monitoring solution for them. The Falco fixed fenceline detector has been chosen to monitor their


ne of the most important areas for VOC (volatile organic compounds)


European facilities as the latest and most advanced fixed VOC detection equipment available. With eight sites identified for upgrading, three were fitted as a priority in 2021, with between 15 and 25 Falco units fitted at each facility due to their large size. Having this many Falco units means


the customer has complete monitoring assurance of VOCs at every stage of production and as fixed units, the Falco needs little in the way of maintenance and will reliably record data on VOC exposure wherever needed. The Falco is enabled with both Modbus and 4-20mA output protocols for site-wide networking capabilities. This gives the customer total confidence that all products and site locations are sterilised within the legal requirements Not only does the Falco fixed


fenceline detector provide complete assurance across sites of any size, other benefits include a user-friendly interface and an easy-fit and service design. The internal lamp comes with a minimum of a one-year lifespan, giving customers reliability and peace of mind. Falco has four detection ranges available, including 0–10ppm, 0–50ppm, 0–1,000ppm and 0–3,000ppm, ideal for any level of sensitivity monitoring. ION Science is proud to be


supporting the medical and pharmaceutical sectors with its advanced PID technology and VOC gas detection instruments for safe working environments and end- products. By working with customers on the ground to equip their sites and find solutions, ION Science continues to advance and develop their portfolio to improve safety and health for all.


ION Science ionscience.com


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