Billions of drugs are counterfeited every year in the world. This has several undesirable effects including loss of precious lives, wrong data that gets generated about the efficacy of good drugs and loss of revenue to the pharma business owners and the government.
Automation system for drug pedigreeTo counter this, the US Food & Drug Administration (FDA) has come out with a ‘drug pedigree’ requirement, where each participant in the pharmaceutical supply chain, has to establish the genuineness of the goods that are exchanged, with a pedigree certificate. If anything goes wrong, not only can the offending drug be easily traced to its source, but also will become very difficult for counterfeiters to inject their deadly goods into the market.
The pedigree requirement will solve diversion of (genuine) drugs from subsidised markets, hospitals and aid schemes to the open market. The pedigree certificate will be issued through a radio frequency identification (RFID) enabled tag that will accompany every bulk drug shipment, pallet or bottle. It allows putting small radio transmitters (in the form of a tag or a smart label), that contains digital information. When a RFID reader is in the vicinity of one or more tags, it can read off the tag data at a distance. A single reader can read data from hundreds of RFID tags, almost simultaneously, within seconds. This is enormously faster and easier than reading bar codes that have to be read serially, require a line of sight and are easily tampered with.Basically the RFID tag emits a signal that is a large serial number. The typical electronic product code (EPC) RFID tag has 96 bits of information; so theoretically, millions of unique serial numbers are possible. This means that every pill bottle produced by any manufacturer can have its own unique RFID tag with a serial number. This serial number will reside in a central database that has other information about the pill bottle, like when manufactured, by whom, batch number, expiry date and so on. This data has to match with the printed label. It will be extremely difficult for counterfeiters to beat the system, because though they can stick an RFID label with a random serial number on a bottle containing fake pills, their serial number will never match the rest of the data that has to be printed on the label.
Wireless instruments measure process parameters and transmit the information wirelessly over a distance. It has an onboard battery that can last for about five years. An antenna on the instrument can communicate with a host (control system) either directly, or through a network of hubs, repeaters, routers and other wireless instruments. The removal of wires means one can mount the instrument practically anywhere, without dressing, shielding and bothering about laying cables. The same transmitter can be used at different times on different equipment. This feature is useful in pharmacy manufacturing plants, as many equipment used in this area, are inherently multi-functional and mobile. Several times an electronic portable weigh scale is used for batching in one process area. The weights are recorded manually for validation, regulatory compliance, and after moving to another area, the process is again repeated. What if the weigh scale was wireless? It could transmit information wirelessly to the control system, every time the operator wished to record the weight. Things would be much faster, simpler and less prone to errors. Also regulatory compliance can be easily achieved, without sacrificing productivity and inherently increasing the reliability of the readings.
Cleaning-In-Place (CIP) applications are another area where wireless instruments can be used to advantage. Many pharmaceutical processes require regular CIP operations to take place at predefined intervals. There are critical CIP data to be monitored and logged, which includes temperature, cleaning agent flow rates, contact time, conductivity, etc. For the same instruments that measure temperature, conductivity, flow, etc, are necessary to be mounted on the CIP. The very nature of the CIP equipment makes it amenable to use wireless instruments. All CIP procedures that are now performed can be logged automatically through wireless instruments, for regulatory compliance and in- process documentation. This will increase the reliability of the cleaning process itself.A type of data logger with a temperature probe that is hermetically sealed is another benchmark in wireless instruments. It can be dropped into a process vessel (a fermentation reactor), where it continues to bob up and down, recording temperature at one minute interval. After the fermentation is over, the data logger is recovered from the vessel and the data inside is read wirelessly. This entire log of readings is useful for validation. The data can be erased and used again in the next batch. Alternatively, one can also have a non volatile memory, so that the data is preserved for a long time, similar to a check sample or counter sample, till the shelf life of the batch is over.
Protection of intellectual property
A company invests millions of dollars in research on a particular molecule, so has to protect its intellectual property (IP) maintain lead, recover investment and make profits, if it becomes a blockbuster. However, IP thieves, pirates and rival firms are always on the lookout for duplication of such molecules, which can be copied, without having to invest in millions of dollars of research. Keeping the processes under wraps is always a major challenge for the original manufacturer. Here, automation comes as a rescue!
Transcending traditional scope
‘Automation’ in the pharmaceutical sector has grown beyond its traditional role in manufacturing. It now plays an increasingly important role not only in manufacturing, but the entire supply chain. For those who can visualise the future possibilities, times are exciting indeed!
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