RFID and sensor technology in pharmaceutical packaging
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RFID and sensor technology can be seen as Cadillac for pharmaceutical packaging. RFID technology for pharmaceutical packaging encryption can really control the fakes completely, and can also provide voice guidance for treatment. The sensor monitors the temperature and storage period of the drug.
Tracking, protection and retrospectiveness give unprecedented drive to pharmaceutical packaging, a new packaging machinery and coding technology that increases patient safety and changes the way pharmaceutical companies manage their supply chains.
In June, the US Food and Drug Administration (FDA) introduced a bar code system for pharmaceuticals in unit doses circulating in hospitals and clinics. The following month, the FDA is actively proposing a new proposal to test techniques that help US pharmaceuticals resist more and more counterfeits.
These two measures are important for the future of pharmaceutical packaging. Not only is the packaging process becoming more complex, it involves more and more complex IT and control systems, and packagers are adapting to FDA's rigorous review. "We changed from a canner to a printer," said Linc Jepson, executive vice president of equipment supply and systems integration services at Lebanon's International NJM/CLIP Packaging Systems.
"How to package pharmaceutical products in the United States, what packaging media to use and the route of circulation is complicated," said analyst and industry consultant for the PA team in Cambridge, England. "But the general direction is clear: the industry is developing a product with an authentication code, so it can be tracked from a pharmaceutical and application perspective."
As the demand for packaging equipment continues to grow healthily, the market for pharmaceutical packaging, especially unit dose products such as blister packs, is expanding at several times. Unit dose packaging, including those commonly found in physician's kits, such as blister packs and tin foil strips, is being promoted by equipment suppliers in Europe, and most prescription drugs are also promoted.
Blisters and tin foils extend the shelf life because they use a protective material to prevent moisture from flowing, making it easier to imprint, and also trying to meet the requirements of "child protection" and "adult convenience", both of which are also federal consumer product safety committees ( CPSC) requirements.
However, unit dose packaging also leads to more advanced equipment and costs. Since the shaping, filling and sealing of the package are done in each position of the packaging line, the operation is more complicated than the traditional packaging. "The blister packer requires more precise control and more work to set and verify process parameters." Howard Leary, vice president of system integration at Luciano Packaging Technologies, said. "They need specific pressure, temperature and expansion time to use and seal the foil backing. This more sophisticated equipment requires a high level of expert operation and verification."
Moreover, the entire concept of unit packaging conflicts with long-standing traditions. Hospitals and large chain pharmacies like its efficiency and retrospectiveness, but pharmacists are relatively cool about the system that drains them from the distribution process.
Like equipment using blister and tin foil, blow-fill-seal (BFS) equipment for gastrointestinal external (liquid injection) medicines, slowly progressing in competition with traditional vials. With a BSF device, a plastic blow molding is formed by a part of the machine to form a container or "bubble", then the injectable drug is filled in the next portion, and finally sealed, including sealing or cutting the bubble opening to adhere some caps or caps. The entire process is carried out in an isolated room, and the drug and air are filtered and purified.
A significant advantage of BFS technology is that the product code, lot number and other identifiers can be stamped on the package with molds and studs, which is done by touching the outer wall during shaping. "Overall, this makes up for the intractable flaws inherent in containers, and there is no need to use labels anymore," explains Chuck Reed, sales manager at Weiler Engineering. Although BFS technology is widely used in Europe and other regions, there is limited progress in the United States, especially for respiratory and ophthalmic solution drugs.
Improve barcode requirements
Since unit dose packaging began to win support in the US, the question is: What code should be on the package? The FDA's plan to implement barcodes on most prescription drugs has been discussed for a year, and it is agreed that unit dose barcodes will significantly reduce treatment errors in medical institutions. The FDA does not currently enforce bar codes, but he hopes the hospital will be able to optimize drugs with barcode packaging.
The proposed rules will not be implemented as early as 2006, so do not expect a rapid large-scale change in unit dose packaging. However, Peter Mayberry, executive director of the Healthcare Compliance Packaging Council, points out that the billions of dollars saved from the reduction in medical errors are expected to make hospitals a strong incentive to the bar code system. The Board of Directors for the promotion of unit dose packaging is in favor of the bar code system from this perspective. Moreover, the Board of Directors has requested the Consumer Product Safety Commission CPSC to explain clearly the provisions on the design features of children's inability, so that the advantages of unit dose packaging will be more obvious, CSPC announced that it will formally study the application of the council in August.
The pharmaceutical packaging industry is likely to transition smoothly to the era of bar code in the future - even if only pharmaceuticals sold to hospitals continue to be repackaged in unit doses, other distribution channels remain unchanged. But many large pharmaceutical companies have not waited for the FDA's final rules. In May, Abbott Laboratories completely renewed all hospital supplies produced into barcodes, primarily injections or intravenous fluids. According to the spokesperson, the change covers more than a thousand varieties of packaging products and represents the company's strategic investment. Abbott's pharmaceutical division, which is primarily involved in most of the filling products, is also working towards this goal; most of the bottled products in the sector are barcoded and testing of the remaining products is underway.
Part of the challenge that pharmaceutical manufacturers have encountered is the development of small enough barcodes 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 space symbolism. Pfizer, GlaxoSmithKline and Baxter Pharmaceuticals are also expanding the use of this technology based on industrial resources.
Market demand for bar code equipment manufacturers' products and information systems integration services. For example, Zebra Technologies and Prisym (a subsidiary of Map Systems, UK) have integrated Zebra's barcode printing system with Prisym's label generation software. Both companies are committed to meeting the requirements of the FDA 21 CFR Part 11 for electronic records and verification improvements.
Support verification of learning curve
Referring to Part 11 of CFR 21, as with other FDA verification and documentation requirements, most packaging system suppliers and integrators are brainstorming.
"The pharmaceutical industry and packaging suppliers have had a lot to learn from each other in the past five years," Luciano Howard Leary said. "The entire process of inspection and verification of packaging equipment is easy to understand. Suppliers now understand that they need to provide detailed design documentation with the equipment. Durability testing is also more stringent."
In January, Eon Laboratories of Laurelton, NY, when the FDA investigators listed eight violations of production, accurately found out what caused the error. The areas that need to be addressed are the company's labeling equipment, the way in which the inventory is sorted and stored, and the way in which the packaging equipment is maintained. 100 bottles of 500 mg of Nabumetone were written as 750 mg tablets due to labeling errors. The products of these batch numbers have been recalled.
The company reported that it had passed the FDA's follow-up inspection before May, and Eon would not explain in detail how they mend the packaging line, but the spokesperson said, "We have put a lot of effort into doing these things, and now the results are very good."
In order to prevent the worst, some pharmaceutical manufacturers believe that the most sensible thing is to simply certify and manage everything on the packaging line according to 21 CFR Part 11.
"The latest guidance on doing risk analysis for electronic records means there is no standard way to handle these tasks," said Nancy St. Laurent, chairman of STL-Lincs, a packaging industry consultant in Omaha, Nebraska. "For example, you might think that you must track the relative humidity of the products stored in the warehouse. But for manufacturers in a dry area of California, where the location is low humidity throughout the year, risk analysis indicates that the humidity check is meaningless."
St. Laurent, who is also the vice chairman of the Basic Steering Committee dedicated to the development of the packaging industry, is supported by the International Association of Pharmaceutical Engineers ISPE. He emphasizes that it is necessary for manufacturers to involve certification experts as early as possible when dealing with corroboration and documentation. In the process.
Rick Pierro, the chairman of the system integrator High Superior Controls, proposed another way to handle the "21CFR black hole", which is simply to ensure that electronic records are not required. "I once had a pharmaceutical customer who used a paper chart to explain the packaging line in detail, not a digital data acquisition system, just to avoid 21 CFR together in the packaging line."
Other integrators and equipment vendors agree, and believe that the most critical aspect of 21CFR Part 11 is the software or control system that can be adjusted or improved, and it is necessary to track who made the adjustments. Some packaging equipment can only be coded by hand. Since there is no convenient control software, there is no need to use this tracking method.