RFID and sensor technology can be seen as Cadillac for pharmaceutical packaging. RFID technology used in pharmaceutical packaging encryption can truly completely control counterfeits, and can also provide voice guidance for treatment. Sensors can monitor the temperature and storage period of pharmaceutical products.
Tracking, protection and traceability give pharmaceutical packaging an unprecedented driving force. This new packaging machine and coding technology improves the safety of patients and changes the way of supply chain management in pharmaceutical companies.
In June, the United States Food and Drug Administration (FDA) proposed a rule to implement a bar code system for unit doses of pharmaceutical products circulating in hospitals and clinics. The following month, the FDA actively put forward a new proposal to test the technology to help US medicines resist more and more fakes.
These two measures are of great significance to the future of pharmaceutical packaging. Not only is the packaging process becoming more complicated, involving more and more complex IT and control systems, packaging workers are also adapting to FDA's rigorous review. "We changed from cannery workers to printers." Said Linc Jepson, executive vice chairman of equipment supply and system integration service provider and international NJM / CLIP packaging systems company in Lebanon.
"How to pack pharmaceutical products in the United States, what packaging media to use and distribution channels are complicated." Said analysts and industry consultants from the PA group in Cambridge, UK. "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 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 a rate several times faster. Unit-dose packaging, including packaging commonly found in physicians ’equipment such as blister packs and tinfoil strips, is being promoted by equipment suppliers in Europe, and so are most popular prescription drugs.
Blister and tin foil extend the shelf life, because the use of protective materials to prevent moisture flow, it is easier to imprint, and can also meet the requirements of "child protection" and "adult convenience", these two requirements are also the Federal Consumer Product Safety Commission ( CPSC) requirements.
However, unit-dose packaging also leads to more advanced equipment and costs. Since the shaping, filling, and sealing of the packaging are completed at each position of the packaging line, the operation is more complicated than the traditional packaging. "Blister packaging machines require more precise control and more work to set and verify process parameters." Howard Leary, vice president of system integration for Luciano Packaging Technology, 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, all the concepts of unit packaging conflict with the long-standing tradition. Hospitals and large chain pharmacies like its efficiency and traceability, but pharmacists are relatively indifferent to this system that expels them from the dispensing process.
Like equipment that uses blister and tin foil, blow molding-filling-sealing (BFS) equipment for external gastrointestinal (liquid injection) medicines is slowly making progress in competition with traditional vials. With the BSF equipment, a part of the machine blows and shapes a plastic to form a container or "bubble", then fills the next part with injection medicine, and finally seals, including sealing or cutting the bubble mouth and attaching some caps or caps. The whole process is carried out in an isolated room, and the medicine and air filtration are purified and sterile.
The significant advantage of BFS technology is that the product code, batch number and other identifiers can be engraved on the packaging with molds and spikes, which is done by contacting the outer wall during shaping. "Overall, this makes up for the inherently difficult to engrave defects of the container, so there is no need to use labels anymore," explained Chuck Reed, sales manager of Weiler Engineering. Although BFS technology is widely used in Europe and other regions, progress in the United States is limited, especially for respiratory and ophthalmic solutions.
Increase bar code requirements
Now that unit-dose packaging has begun to gain support in the United States, the question is: what code should be on the packaging? After a year's discussion of the FDA's plan to implement bar codes for most prescription drugs, proponents claim that unit-dose bar codes will significantly reduce medical institutions' treatment errors. The FDA does not enforce bar codes now, but he hopes that hospitals will prefer drugs with bar code packaging.
The proposed regulations will not be implemented before 2006, so do not expect a rapid large-scale unit-dose packaging change. However, Peter Mayberry, executive manager of the Healthcare Compliance Packaging Council, pointed out that the billions of dollars that are expected to be saved from the reduction of medical errors will make hospitals welcome strong incentives for bar code systems. The council built to promote unit-dose packaging favors the bar code system from this perspective. Moreover, the Council has requested the CPSC to explain clearly about the design features that children cannot, so that the advantages of unit-dose packaging will be more obvious. CSPC announced that it will formally study the Council ’s application in August.
The pharmaceutical packaging industry may transition smoothly to the future barcode era-even if only the medicines sold to the hospital continue to be repackaged in unit doses, other distribution channels remain unchanged. But many large pharmaceutical manufacturers have not waited for the final FDA regulations. In May, Abbott Laboratories completely updated all the hospital supplies produced with barcodes, mainly injections or intravenous fluids. According to the spokesperson, this change covers more than a thousand varieties of packaging products and represents the company's strategic investment. Abbott's pharmaceutical department, which is mainly involved in most of the filling products, is also working towards this goal; most of the bottled products in this department are barcoded, and the remaining products are being tested.
Part of the problem that pharmaceutical manufacturers have encountered is developing bar codes that are small enough to fit unit-dose packaging. Abbott works with the Standard Code Committee, the national agency that manages bar code standards, to create codes using protocols that simplify spatial symbology. Pfizer, GlaxoSmithKline, and Baxter Pharmaceuticals are also expanding the use of this technology based on industry resources.
Bar code equipment manufacturers respond to market demands with products and information system integration services. For example, Zebra Technology Company and Prisym (a subsidiary of Map System in the United Kingdom) cooperate to integrate Zebra's barcode printing system with Prisym's label generation software. Both companies are committed to meeting FDA 21CFR Part 11 requirements for improved electronic records and verification regulations.
Support verification learning curve
When referring to Part 11 of CFR21, as with other FDA verification and record requirements, most packaging system suppliers and integrators use their brains.
"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 documents with the equipment. Durability testing is also more stringent."
In January, when the FDA investigator listed eight of the company ’s production violations, the packaging company Eon Laboratories in Laurelton, New York, found exactly what caused the error. The aspects that need to be solved are the company's labeling equipment, the way of inventory classification and storage, and the way of packaging equipment maintenance. 100 bottles of 500mg Nabumetone were written as 750mg tablets due to marking errors. These batches of products have been recalled.
The company reported that it passed the FDA follow-up inspection before May. Eon will not explain in detail how they repaired the packaging line, but the spokesperson said, "We have spent a lot of energy doing these things, and now the results are very good."
To prevent the worst-case scenario, some pharmaceutical manufacturers believe that the most sensible approach is to simply certify and manage all matters on the packaging production line in accordance with 21CFR Part 11.
"The latest guidance section on electronic records for risk analysis means that there is no standard way to handle these tasks," said Nancy St. Laurent, chairman of STL-Lincs, a packaging industry consultant in Omaha and Nebraska. "For example, you may think that the relative humidity of the products stored in the warehouse must be checked. But for a manufacturer in a dry area of ​​California, where the humidity is low all year round, a risk analysis shows that the humidity check is meaningless."
St. Laurent, also a vice chairman of the basic steering committee dedicated to the development of the packaging industry, they are supported by the International Association of Pharmaceutical Engineers ISPE. He emphasized that manufacturers must ensure that certification experts participate in the design as soon as possible when handling confirmation and documentation matters. In the process.
Rick Pierro, chairman of the system integrator Superior Controls, proposed another method to deal with the "21CFR black hole", which is simply to ensure that electronic records are not required. "I once had a pharmaceutical customer who used a chart to explain the packaging production line in detail, rather than a digital data collection system, just to avoid 21 CFR in the packaging line part."
Some other integrators and equipment suppliers also agree and believe that the most critical aspect of 21CFR Part 11 is related to adjustable or improved software or control systems, and it needs 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 use this tracking method.
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