RFID and sensor technology can be seen as Cadillac for pharmaceutical packaging. RFID technology used for pharmaceutical packaging encryption can truly control fakes completely, and can also provide voice guidance for treatment. Sensors can monitor the temperature and storage period of pharmaceuticals.
Tracking, protection, and retrospectiveness give pharmaceutical packaging an unprecedented driving force. This new type of packaging machinery and coding technology improves patient safety and changes the way pharmaceutical companies manage supply chains.
In June, the U.S. Food and Drug Administration (FDA) introduced a regulation that implements a bar code system for unit doses of medicines circulating in hospitals and clinics. The following month, the FDA actively proposed a new proposal to test technologies that help American pharmaceuticals counteract more and more counterfeits.
These two measures are of great significance to the future of pharmaceutical packaging. Not only is the packaging process becoming more complex, it involves increasingly complex IT and control systems, and packaging workers are also adapting to the FDA's rigorous review. "We have changed from pressure potters to printers," said Linc Jepson, executive vice president of equipment supply and system integration at Lebanon's International NJM/CLIP Packaging Systems Company.
"The packaging of pharmaceutical products in the United States, what packaging media to use, and the route of distribution are complex," said analyst and industry consultant for the PA group in Cambridge, England. "But the overall direction is very clear: the industry has evolved into a product-coded identification system, so it can be tracked from the point of view of pharmaceuticals and applications."
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 faster. Unit-dose packages, including packages commonly found in physicians' kits such as blisters and tinfoil strips, are being promoted by equipment suppliers in Europe, as are most prescription drugs.
Blisters and tin foils have extended shelf life because the use of protective materials to prevent moisture flow makes it easier to imprint, and it also seeks to meet the "children protection" and "adult convenience" requirements, both of which are also Federal Consumer Product Safety Commissions ( CPSC) requirements.
However, unit dose packaging also leads to more advanced equipment and costs. Because the shaping, filling, and sealing of the packaging are performed at each position of the packaging line, the operation is more complicated than the conventional packaging. "The blister packaging machine needs more precise control and more work to set and verify process parameters," said Howard Leary, vice chairman of Luciano Packaging Technologies' system integration process. "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 whole concept of unit packaging conflicts with the long tradition. Hospitals and large chain pharmacies like it for efficiency and retrospectives, but pharmacists are less enthusiastic about the system that will be dispensing them out of the dispensing process.
Like equipment using blisters and tin foils, blow-fill-seal (BFS) equipment for gastrointestinal (liquid injection) drugs is slowly making progress in competition with traditional vials. With BSF equipment, a plastic part is blow molded by one part of the machine to form a container or "bubble", and then injection medicine is filled in the next part, and finally sealed, including sealing or cutting off the mouth of the material and adhering some caps or caps. The entire process is carried out in an isolated room and the medicine and air are purified and sterile filtered.
The significant advantage of the BFS technology is that the product code, lot number and other identifiers can be engraved on the package with a die or thorn imprint. This is done by contacting the outer wall during shaping. "Overall, this compensates for the inherently hard-to-print defects of the container and eliminates the need for labels," explains Chuck Reed, sales manager at Weiler Engineering. Although BFS technology is widely used in Europe and other regions, there has been limited progress in the United States, especially for respiratory medicine and ophthalmic solution medicines.
Increase barcode requirements
Since unit dose packaging began to gain support in the United States, the question is: What code should be on the packaging? FDA's plan to implement bar codes for most prescription drugs has been discussed for a year, and the pros have claimed that unit-dose bar codes will significantly reduce treatment errors at medical institutions. The FDA does not currently enforce bar codes, but he hopes that the hospital will be able to optimize bar code-packaged drugs.
The proposed regulations will not be implemented earlier than 2006, so do not expect a rapid, large-scale change in unit dose packaging. However, Peter Mayberry, executive manager of the Healthcare Compliance Packaging Council, pointed out that the estimated billions of dollars saved from the reduction in medical errors will enable hospitals to welcome the strong incentives of the barcode system. The council established to promote the unit dose packaging is in favor of the bar code system from this perspective. Moreover, the Council has requested the Consumer Product Safety Commission CPSC to explain clearly the rules for the design characteristics of children, so that the advantages of unit dose packaging will become more apparent. The CSPC announced that it will formally study the Council's application in August.
The pharmaceutical packaging industry may have a smooth transition to the bar code era of the future - even if only pharmaceuticals sold to hospitals continue to be repackaged in unit doses, other distribution channels remain unchanged. But many large drug makers have not waited for the FDA's final rule. In May, Abbott Laboratories completely updated all hospital supplies produced to bar codes, mainly injections or intravenous fluids. According to the spokesperson, the change covered more than a thousand varieties of packaging products and represented the company's strategic investment. The Abbott Pharmaceuticals Division, which involves most of the filling products, is also working towards this goal; most of the bottled products in this sector are bar codes, and testing of the remaining products is ongoing.
Part of the challenge that has been encountered by pharmaceutical manufacturers is the development of sufficiently small barcodes to be suitable for unit dose packaging. Abbott works with the Standard Code Committee of the National Institute for the Management of Barcode Standards to create codes using protocols that simplify space symbology. Pfizer, GlaxoSmithKline and Baxter Pharmaceuticals are also expanding the use of this technology based on industrial resources.
The market demand for bar code equipment manufacturers to respond to product and information system integration services. Zebra Technologies, in partnership with Prisym (a subsidiary of Map Systems of the United Kingdom), integrated Zebra's bar code printing system with Prisym's tag generation software. Both companies are committed to meeting the FDA 21 CFR Part 11 requirements for electronic records and verification improvements.
Support verification of learning curve
Referring to CFR21 Part 11, as with other FDA verification and record requirements, most packaging system suppliers and aggregators have a brainwave.
"The pharmaceutical industry and packaging suppliers have had to learn from each other in the past five years," said Luciano Howard Leary. "The entire process of inspection and verification of packaging equipment is easy to understand. Vendors now understand that they need to provide detailed design documentation with the equipment. Durability tests are also more stringent."
In January, Eon Labs, a packaging company in Laurelton, New York, spotted exactly where the error occurred when the FDA investigators listed the company's eight violations of production. The areas that need to be addressed are the company's label equipment, inventory classification and storage methods, and maintenance of packaging equipment. 100 bottles of 500 mg of Nabumetone were written as 750 mg tablets due to incorrect marking. These batches of products are recalled.
Before May, the company reported that it had passed the FDA follow-up inspection. Eon would not explain in detail how they would repair the packaging line, but the spokesperson said: "We spent a lot of energy to do these things. Now we see that the results are good."
In order to prevent the worst case scenario, some pharmaceutical companies believe that the most sensible approach is to simply certify and manage all aspects of the packaging production line in accordance with 21 CFR Part 11.
"The most recent guidance section on doing electronic records for risk analysis means there is no standard way to deal with these tasks," said Nancy St. Laurent, chairman of STL-Lincs, a packaging consultant for Omaha and Nebraska. "For example, you may think that the relative humidity of products stored in warehouses must be tracked. But for manufacturers in a dry area of ​​California, where the site is low-humid throughout the year, the risk analysis shows that humidity testing is meaningless."
St. Laurent, who is also the vice chairman of a basic steering committee dedicated to the development of the packaging industry, was supported by the International Association of Pharmaceutical Engineers ISPE. He emphasized that it is the manufacturers who must be involved in the design as early as possible when dealing with certification and documentation. In the process.
Rick Pierro, chairman of System Integrator Superior Controls, proposed another approach to deal with the "21CFR black hole", which is simply to ensure that no electronic records are made. "I once had a pharmaceutical customer who explained the packaging line in detail using paper charts, not the digital data acquisition system, just to avoid 21 CFR together in the packaging line."
Some other integrators and equipment vendors also agree, and believe that the most critical aspect of the 21CFR 11 part is related to adjustable or improved software or control systems, which need to keep track of who made adjustments. Some packaging equipment can only be hand coded. Since there is no convenient control software, there is no need to use this tracking method.