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For some manufacturers the FDI’s ruling for UDIs to be assigned to medical devices could have implications from the label materials to verification of the data printed on them

production and the selection of the most appropriate coding method. Combining this expertise with available printing and application technologies means that solutions for each stage of the manufacturing process from device production to pallet labeling can be configured to meet the individual requirements of each manufacturer Healthcare labels have to communicate

On-press, variable

code-dating and messaging using laser etch or UV inkjet allows information to be added on the fly with sequential back-of-liner numbering aiding inventory control


he FDA’s ruling requiring UDIs (unique device identifiers) to be

assigned to medical devices and their related packaging will undoubtedly bring many benefits. Patient safety will be greatly enhanced through increased protection from counterfeit devices and the ability to identify a device even when it has been separated from its packaging will make it much easier to link the product to its original manufacturer in the event of problems. For some manufacturers the ruling

could have implications across different aspects of their manufacturing processes from the materials used to produce a label through to the verification of the information printed to it. Weber is able to provide the expertise, guidance and technologies needed to ensure a smooth transition to conformity. In practice UDI is a unique numeric or

alphanumeric code which includes a device identifier specific to a model and a production identifier. Included is the current production information for that specific device such as lot or batch number, serial number and/or expiration date. The UDI must appear on every device using a label or through direct marking methods such as ink jet or lasers. The information must be both human readable in the form of plain text and machine readable through bar code, 2D Matrix code or RFID technology. Several compliance dates are identified within the FDA’s final ruling periodically until September 2020.


Keeping abreast of these regulations and ensuring compliance at the different stages of implementation requires an intimate knowledge of the industry, the requirements and the materials and technologies needed to support the production processes. Many suppliers to the industry may be small and medium size enterprises (SMEs) and for them UDI compliance could be costly not only in terms of labelling system upgrades but in the management time needed to understand and administer the changes needed to comply with ever changing regulatory requirements. Manufacturers must include at least one method of allowing automatic identification/data capture (AIDC). This can be in the form of a conventional bar code but where space may be an issue or greater amounts of data need to be made available the 2D Matrix or QR codes can be used. It is possible to use RFID labeling but the additional costs incurred may exclude this as an option in certain cases. End users may have a preferred technology that they wish to use to acquire the data from the device, its label or packaging and this will have a direct influence on the AIDC method to be used at the time of manufacture. SMEs who supply several customers may need to use different methods as some will require bar codes while others may prefer 2D Matrix codes. Weber’s understanding of the industry’s

requirements enables it to offer expert guidance on label materials and design,

important information to both doctors and patients. It is essential therefore that they are capable of withstanding the most arduous environmental conditions. Weber's extensive knowledge of label materials helps manufacturers select the most appropriate substrate, adhesives and topcoats to ensure compatibility with the ETO, Gamma and E-Beam sterilisation processes used within the medical sector. Weber has developed creative solutions to the many problems faced by healthcare companies including custom die cuts and complex build. On-press, variable code-dating and

messaging using laser etch or UV inkjet allows information to be added on the fly with sequential back-of-liner numbering aiding inventory control. On-press and post-press video inspection is used to maintain the highest levels of quality assurance and Weber employs ISO 9001- registered label manufacturing processes that can assist cGMP compliance to 21 CFR Subpart G. Weber’s extensive range of printers, applicators and print & apply systems means that there is always an optimum solution to every application. Thermal inkjet systems iJet, XJet and Cube marking systems meet the medical device industry’s challenging demands on printing, speed and reliability and are easily integrated into production and packaging facilities. Although compact they are able to print all of the requisite codes and information needed for UDI compliance. Weber offer labeling systems for indirect product marking which can be integrated and used for downstream packaging operations. In addition to standard product and pallet label applicators the range includes RFID solutions, providing manufacturers with the widest choice of labeling solutions to meet UDI requirements irrespective of the device and its packaging.

Weber Packaging Solutions T: 01875 611 111


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