RFID and sensor technology in the hottest pharmace

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RFID and sensor technology in pharmaceutical packaging can be regarded as Cadillac for pharmaceutical packaging. RFID technology used in pharmaceutical packaging encryption can truly and completely control counterfeit products, but also provide voice guidance for treatment. Sensors can monitor the temperature and storage period of pharmaceuticals

tracking, protection and traceability give unprecedented driving force to pharmaceutical packaging. This new packaging machinery and coding technology improve the safety of patients and change the way of supply chain management of pharmaceutical enterprises

in June, the U.S. Food and Drug Administration (FDA) proposed a regulation to implement the bar code system for the unit dose of pharmaceuticals circulating in hospitals and clinics. The following month, FDA actively put forward a new proposal to test the technology that helps American drugs resist more and more counterfeit products

these two measures are of great significance to the future of pharmaceutical packaging. Not only is the packaging process becoming more complex, involving more and more complex it and control systems, packaging workers are also adapting to the strict FDA review. "We changed from can pressing workers to printers." Linc Jepson, executive vice president of international njm/clip packaging systems in Lebanon, a provider of equipment supply and system integration services, said

"in the United States, how pharmaceutical products are packaged, what packaging media are used and how to circulate are complex." Analysts and industry consultants from the PA group in Cambridge, England said. "But the general direction is very clear: the industry is developing towards the structure of products marked with identification codes, so it can be tracked from the perspective of pharmacy and application."

when the demand for packaging equipment continues to grow healthily, the pharmaceutical packaging market, especially the unit dose products such as blister packaging, is expanding at a rate of several times. Unit dose packaging, including packaging commonly used in doctors' complete sets of equipment, such as blisters and tin foil strips, is being promoted by equipment suppliers in Europe, as is the case with most prescription drugs

bubble eyes and tin foil extend the shelf life. Because protective materials are used to prevent moisture flow, they are firm, beautiful, durable and easy to mark. They can also try to meet the requirements of "child protection" and "adult convenience", which are also the requirements of the federal consumer product safety commission (CPSC)

however, unit dose packaging also leads to higher equipment and costs. Since the shaping, filling and sealing of packaging are completed in each post of the packaging line after years of development, the operation is more complex than traditional packaging. "Bubble eye packaging machine needs more precise control and more work to set and verify process parameters." Howard Leary, vice president of Luciano packaging technology in charge of the system integration process, said. "They need specific pressure, temperature and expansion time to use and seal tin foil backing. This more sophisticated equipment requires high-level expert operation and verification."

moreover, the whole concept of unit packaging conflicts with the long-standing tradition. Hospitals and large chain pharmacies like its efficiency and traceability, but pharmacists are indifferent to the system that removes them from the distribution process

equipment such as bubble eye and tin foil, blow molding filling sealing (BFS) equipment, and drugs for gastrointestinal external use (liquid injection) are slowly making progress in the competition with traditional vials. With BSF equipment, a plastic is blow molded into a container or "bubble" by one part of the machine, and then the injection drugs are filled in the next part, and finally sealed, including sealing or cutting off the bubble mouth and adhering some caps or caps. All processes are carried out in an isolated room, and the drugs and air are filtered, purified and sterile

bfs technology has the obvious advantage that product code, batch number and other identifiers can be engraved on the package with molds and spikes, which is completed by contacting the outer wall during molding. "In general, this makes up for the inherent defects of the container that are difficult to print, and there is no need to use labels." Chuck reed, sales manager of Weiler engineering, explained. Although BFS technology is widely used in Europe and other regions, its progress in the United States is limited, especially for respiratory and ophthalmic solution drugs

improve bar code requirements

since unit dose packaging has begun to win support in the United States, the question is: what code should be carried on the packaging? After a year of discussion on the FDA's plan to implement bar codes for most prescription drugs, proponents claimed that unit dose bar codes would significantly reduce treatment errors in medical institutions. FDA does not enforce bar code now, but he hopes hospitals can choose drugs with bar code packaging

the proposed regulations will not be implemented before 2006, so do not expect a rapid and large-scale change in unit dose packaging. However, Peter Mayberry, executive manager of healthcare compliance Packaging Council, pointed out that the billions of dollars saved from the reduction of medical errors are expected to make hospitals welcome the strong incentive of bar code system. The Council established to promote unit dose packaging supports the bar code system from this point of view. Moreover, the Council has requested the CPSC of the consumer product safety committee to explain clearly the provisions on the design characteristics of children's disability, so that the advantages of unit dose packaging will be more obvious. CSPC announced that it would formally study the Council's application in August

the pharmaceutical packaging industry may smoothly transition to the future bar code era - even if only pharmaceutical products sold to hospitals continue to be repackaged in unit dose, other distribution channels remain unchanged. However, many large pharmaceutical companies did not wait for the final regulation of FDA. In May, Abbott laboratory completely updated all hospital supplies produced to bar codes, mainly injections or intravenous injections. According to the spokesman, this change covers more than 1000 varieties of packaging products, representing the strategic investment of the company. Abbott pharmaceutical sector, which mainly involves most of the filling products, is also working towards this goal; Most of the bottled products of the Department are bar coded, and the testing of the remaining products is ongoing

part of the problem that pharmaceutical manufacturers have encountered is to develop bar codes that are small enough to be suitable for unit dose packaging. Abbott works with the national agency Standard Code Committee, which manages bar code standards, to create codes using protocols that simplify spatial symbolism. Pfizer, GlaxoSmithKline and Baxter pharmaceutical are also expanding the application of this technology according to industrial resources

barcode equipment manufacturers respond to market demand for commercial products and information system integration services. For example, zebra technologies and Prisym (a subsidiary of map systems in the UK) cooperated to integrate zebra's bar code printing system with Prisym's label generation software. Both companies are committed to meeting the requirements of FDA 21cfr Part 11 for electronic records and verification improvement

support verification learning curve

refer to part 11 of cfr21. Like other verification and record requirements of FDA, most packaging system suppliers and integrators use their brains

"the pharmaceutical industry and packaging suppliers have a lot to learn from each other in the past five years," Luciano Howard Leary said. "The whole process of inspection and verification of packaging equipment is easy to understand. Suppliers now understand that they need to provide detailed design documents with the equipment. Durability testing is also more stringent."

in January, when FDA investigators listed eight places where the company violated production, eon laboratory, a packaging company in Laurelton, New York, found exactly what caused the error. The aspects that need to be solved include the company's labeling equipment, the way of inventory classification and storage, and the way of packaging equipment maintenance. Due to the wrong marking, 100 bottles of 500mg nabumetone were written as 750mg tablets. These batches of products have been recalled

before May, the company reported that it had passed the follow-up inspection of FDA, and eon would not explain in detail how they repaired the packaging line, but the spokesman said, "we spent a lot of energy on these things, and now the results are very good."

in order to prevent the worst, some pharmaceutical manufacturers believe that the wisest way is to simply certify and manage everything on the packaging production line according to 21cfr Part 11

"the latest guidance on making electronic records for risk analysis means that there is no standard way to deal with these tasks," said Nancy St. Laurent, chairman of STL LinCS, a packaging industry consultant in Omaha and Nebraska. "For example, you may think it is necessary to track and check the relative humidity of products stored in the warehouse. But for a manufacturer in a dry area of California, the humidity is low all year round, and the risk analysis shows that humidity inspection is meaningless."

st. Laurent is also the vice chairman of a basic steering committee dedicated to the development of the packaging industry. They are supported by ISPE. He stressed that manufacturers must recognize and support express enterprises to carry out the pilot of "industrial product ecological (green) design" as early as possible when dealing with confirmation and documentation, and that experts should participate in the design process

rick Pierro, the chairman of Gao superior controls, a system integrator, proposed another method to deal with his "21cfr black hole" with low experimental speed, which is simply to ensure that electronic records are not allowed. "I once had a pharmaceutical customer who used chart records on paper to explain the packaging production line in detail, rather than a digital data acquisition system, just to avoid 21 CFR in the packaging line."

other integrators and equipment suppliers also agree that the most critical aspect of 21cfr Part 11 involves adjustable or improved software or control systems, and it is necessary to track when and who made the adjustment. Some packaging equipment can only be coded manually. Since there is no convenient control software, there is no need to adopt this tracking method. (end)

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