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In March, the GS1 Global Healthcare User Group passed the Medical Product Traceability Standard (GTSH), which aims to ensure interoperability across the healthcare supply chain and cross-border traceability systems. The International Article Numbering Association Health Care User Group is a neutral, non-profit organization dedicated to planning and implementing global standards and solutions to improve the efficiency and visibility of the supply chain.
Ensuring compliance with such standards is critical to companies such as FPDevelopments(), which manufacture production lines for the pharmaceutical and healthcare industries. In some manufacturing lines, FPDevelopments engrave the fiber laser code marking the data matrix code, batch code or fill code on the aluminum ring of the vial. These aluminum rings are typically less than 1/4 inch tall, and the height of these markers is about 1/8 inch, leaving little room for false markings. The company reported a false positive rate of less than 0.5% on its production line and can customize the code based on the requirements of different customers or products shipped to the country.
The marking code must be clear and accurate, and there is a visual system on the production line to verify these marking codes. In addition, handheld barcode scanners can read these barcodes at certain end users. Once required by the customer, FPDevelopment is able to integrate all technologies into one production line for tracking and tracing.
The International Article Numbering Association's medical product traceability criteria include the identification of parties, projects and events, traceability of items, markings and labels, the nature and type of data to be acquired and collected, including records for archival and data storage, and Communication and information sharing (displaying information through package labels and printed barcodes). All traceable items must have a designated label and be tagged or tagged with the source. Traceability data includes information about who, where, when, what, and what.
In order to allow customers to comply with such standards, FPDevelopments designed and built its own laser and verification system. For a pharmaceutical customer, the company devised a system whose sole purpose was to transport and position vials using a fiber laser and a vision system through two-dimensional encoding and verification procedures. This system is capable of handling glass vials at a rate of 300 bottles per minute. This laser encoding and verification system is designed for the integration of the Videojet 7310 fiber laser marking system and the CognexVision 5600 Insight monitoring system. The system sends the vial to the laser machine, marks the surface of the sealing skirt, and then reads the information on the vial through the vision system, which either passes or is identified as having a problem. All approved vials can continue to pass through the system. All problematic vials were sent to a tray dedicated to unqualified vials. The system is designed to mechanically integrate all upstream and downstream equipment.
The laser machine is capable of marking a machine readable two-dimensional data matrix on a moving vial. This two-dimensional data matrix is ​​12 x 26 in size and can contain 22 characters (letters mixed with numbers). The laser machine directly obtains the two-dimensional data matrix value from the production line master computer.
The Model 7310 20 Watt Pulsed Fiber Laser is a compact, versatile and easy to maintain marking system. One of its features is a software that creates tag information that allows users to create content that automatically updates content (such as date, time, and conversion), symbols, patterns, foreign languages, fonts, and imported artwork or project files. Mark information.
For more than a decade, FPDevelopments has been doing business with Videojet. At the beginning of zui, FPDevelopments integrated Videojet's inkjet machines into their systems to print on flyers, boxes, cartons and labels. However, the labeled product cannot withstand the necessary terminal sterilization process, and the finished product must be verified to destroy all living microorganisms. Terminal sterilization can be accomplished using ethylene oxide gas, radiation (gamma and electron beam), steam or dry heat. In addition, the quality of inkjet coding cannot meet the quality requirements of many industries.
Editor's Note: At present, the safety, traceability and effectiveness of health care are the top priorities of government regulations and industry attention around the world. Some of the key issues include forgery, product recalls, adverse reaction reports, medical negligence, and efficient logistics management.