Drug safety starts with packaging
no matter what technology is selected, packaging design requires consideration of the worst case
implementing product safety in the packaging stage is a bit like ordering in a restaurant with a long 9-Page menu. There are always so many choices that you begin to doubt whether the guest sitting at the table next to you has ordered a better dish than you
in fact, the safety packaging technology should be like a buffet, because there is not only one dish, and even radio frequency identification can meet the actual needs. Although RFID has incredible and almost all-round safety regulation function for everything from human body to medicine, there is still great uncertainty in technology and business
a better safety packaging scheme should flexibly combine high-tech and non high-tech, and should have a clear understanding of where problems may arise
rfid is not intelligent
when asked where RFID may have problems, Amar Singh, the global vice president of RFID at sap, joked, "RFID has never had any problems."
of course, this is just a joke. All companies that have the same pursuit as RFID will find themselves in a dilemma between irreversible trends and mandatory medical bills. The distance of reading labels varies widely, from a few feet to a few meters, and there are many different forms of conflict. "The radio frequency is affected by density, surrounding metals including outer packaging and aluminum foil, the direction of the receiving antenna, and liquid substances." Singh added, "what you read in magazines or technical manuals is not necessarily what you actually get."
although the principle of solid geometry is also used in the practical application of RFID, once the label is pasted in the wrong place, it may not be read correctly. Singh gave an example. One customer set up label reading at both transportation entrances and exits, one of which operated normally, while the other interrupted the data transmission pointer due to the moisture of the instrument caused by the water pipe installed near the gate, and the needle position was adjusted for evacuation. Another customer pasted RFID tags on the bottles, but at the same time, they used metal shrinkable film packaging. Although aluminum foil is a good product packaging, it also increased the reading difficulty because the labels must be read from the inside of the bottles
"obviously, RFID does not have enough intelligence to apply to any environment," Singh concluded. "Although RFID will undergo various physical changes with the environment, testers must imitate various actual environments, including different locations, and there is no other way except testing in the real environment."
the economy of RFID has also begun to suffer, and the growth method will be the best choice. "We should realize the potential of technology at a higher level, specific to a batch or a container of products; of course, we should also fully understand the challenges we will face before specific applications." Singh also suggested
the third limitation of RFID application is what Singh calls "limitations of data collection", which means that unless all RFID back-end information can be obtained in real time, it may not be as good as none - because it may become an obstacle in practical application. Another situation is the abuse of RFID's rich data acquisition capabilities. When the daily sales data are sufficient, pharmaceutical manufacturers do not need to know the real-time situation of each production activity. Utility, practicality and availability should be regarded as the end - technology itself is only a means, not an end
"in many cases, RFID is just bar code, but it has almost always revived and promoted the capabilities that are theoretically applicable to bar code but have never been flexibly practiced." Singh commented, "these capabilities can reduce the cost of data collection and get more accurate data in addition to the printed code."
the miracle of security technology
the FDA outline requires that RFID throughout the industry be launched before 2007. In 2005, pharmaceutical manufacturers should apply this technology at the tray level, and in 2006, it must be applied at the container level
but is such a schedule realistic? Technology and data are always limited by certain barriers
"RFID is experiencing the pain of growth that grocery scanning systems experienced 15 years ago," said don McMillan, vice president of marketing at western pharmaceutical company
pharmaceutical manufacturers and packaging enterprises hope to adopt new safety measures to cope with higher-level competition, which comes not only from regulations, but also from the needs of their own development. People have designed high-speed packaging lines to carry out specific operations, "adding barcodes or integrating RFID tags requires or does not require time and additional verification." McMillan said, "and regardless of the amount of validation drafts, errors are sometimes inevitable." If RFID makes a small error in the details of the barcode, the error will be doubled, resulting in the misreading of important information on the label
according to Kevin Prouty, senior director of symbol technology manufacturing industry service group, there are three forms of RFID operation, "one is normal operation, one is normal operation and continuous improvement, and the other is inoperable."
this sounds a little harsh, but it is true in the pharmaceutical industry, where 99% accuracy is still not enough. "Manufacturing without calibration may allow 80% of the 1.1 drop cumulative code reading accuracy," Prouty said. "But in the pharmaceutical industry, you have to ask to verify the 99.999% accuracy. RFID shows defects in reliability, so that pharmaceutical manufacturers cannot correctly read the plane code."
the technical basis of tracking and recording application, even bar code technology, has not yet been born today. Renard Jackson, executive vice president of Cardinal Health packaging services, believes that the processing process of large amount of information and its technology, cost and verification are still unsolvable problems so far
safety measures must reconcile the huge differences between unit dose and batch products, as well as the special requirements of different links of the supply chain. "In terms of meeting market demand, risk assessment is still immature, even for about 30 kinds of products that FDA points out have a high risk of forgery." Jackson said so
the high cost of RFID is a commonplace. In fact, the cost increase of single-chip drugs by applying RFID at the tray level and container level is negligible (if the time cost and non label cost are ignored). However, the calculation of return on investment is still ambiguous. If safety technologies have adverse effects, pharmaceutical manufacturers must re-examine such investments for the sake of insurance, and such investments will only be remembered when needed
on the basis of the existing production speed, it may be impossible to apply, print and add safety signs to the packaging. The more mature the means are, the slower the production line is bound to be
make Gutenberg Germany proud
the attraction of gadgets is sometimes so tempting that people ignore real, reliable, low-tech (but sometimes not necessarily low-cost) printing security measures. Color changing pigments can display different colors and patterns from different perspectives. The application of this technology may cost US $250000 for the comprehensive introduction of relaxation testing machine. The cost of this pigment itself is $5000 per pound (while the same amount of black ordinary pigment only costs a few dollars). Most of the cost is spent on developing color schemes, because each pigment has its own characteristics. The return of these costs for pharmaceutical manufacturers is the improvement of safety
but even the most mature security measures are easy to imitate. "As long as you spend a sufficient amount of money, nothing can be imitated by counterfeiters," said Bill Mitchell, President of Cardinal Health packaging services. He firmly believes that the reason why the current printing security technology market exists is that it needs to transition before adopting RFIDRobert allsopp, vice president of Gans safety pigment company, said that smart packaging suppliers will consider the safety and design of packaging by working with the design and loss prevention team at an early stage. Establishing a security mechanism before design and planning will be simpler, more effective and less costly
it is equally important to think about security technology based on printing and RFID plan. Allsopp believes that "we must always think about the characteristics of application and distribution." For example, hot pigments will change color when the temperature rises, but their effect is not obvious at higher temperatures, unless specially designed
similarly, if the doorman cannot use the reader and device to identify the product, it is not very appropriate to use less obvious printing technology at this time, such as infrared reading, fluorescent reading, non pen writing or other protective features
at the packaging design stage, packaging experts are required to participate in the formulation of printing safety plans. Otherwise, as a printer said, a 5 The six color unit printing of fuse free switch (circuit breaker) and temperature over temperature protector will not be able to produce six color packaging, even if excellent safety printing pigments are used. According to the earlier requirements for safety and aesthetics, printers may recommend pigments that integrate color and safety features. "It is feasible to integrate up to four safety features into one pigment," allsopp said. "This not only provides an opportunity to use the same printing unit to form multi-layer protection, but also provides a more economical solution for mass production." (end)
source: international pharmaceutical processing and packaging business information