EU legislation challenges
Romaco, from Huntingdon, UK, demonstrated a number of solutions to help manufacturers meet their obligations under recent and impending EU legislation.
The company's Noack 623 blister packer was demonstrated with the Pill Protect pharmaceutical blister overlabelling system, the first solution for enhancing the child-resistant properties of blisters to achieve BS8404 certification. Compliance with this British Standard will become mandatory for producers of aspirin, paracetamol and some iron products in the coming months; the Pill Protect system offers manufacturers a straightforward means of satisfy their obligations without major modifications, pack design or significant licence variation.
The system involves the application of a label over the foil of each blister; a two-stage 'peel and push' action is therefore required to remove each product. The design of the Noack 623 accommodates with ease the installation of an on line labeller necessary to apply the Pill Protect solution. The GMP-compliant design of the machine is uncomplicated and allows high visibility during operation, combined with easy access to all areas. The model can incorporate a pick-and-place outfeed system, permitting operation at speeds up to 70 cycles/min.
As a consequence of new legislation in November last year, it has become compulsory to use a special vignette label for pharmaceutical products supplied to the Italian and other markets. The scheme, whose objective is to reduce fraud, poses various challenges for manufacturers, including the requirement to read consecutively-numbered labels. A collaboration between Romaco Laetus and Italian security printer and labelling machine manufacturer Arca has produced a system to meet the new requirements without compromising productivity.
Named IVT (International Vignette Tracking), the system consists of proven components such as Laetus code cameras, laser scanners and the Commander 15 industrial computer, combined with the ARCA-log software package, already proven in other sectors. Its particular appeal lies in its modular design, comprising sections relevant to each stage of the packaging operation. The design also allows flexibility for future upgrades.
The Italian Government's initiative was prompted by a need to meet new obligations in the area of pharmacovigitance imposed by the EU. Other Member States using the vignette system for reimbursement are currently considering the options for compliance.
The US FDA has recently indicated it will be mandatory for each unit dose of pharmaceutical products administered by professionals to be coded. The objective of the proposal is to reduce medication errors by providing a code to be scanned at the point of administration. With the space available for each unit dose being potentially very small, standard code symbologies may not be practical for this application. Romaco Hapa, a leader in on-line printing for pharmaceutical packaging, has been working in closely with a number of pharmaceutical manufacturers on the implementation of Reduced Space Symbology (RSS) codes on unit dose blisters. This compact code technology includes fields for both fixed and variable data, all of the information including the lot and expiry date.
With the Romaco Hapa 730 'Digiprint' codes are generated automatically and imported into the relevant artwork immediately prior to the production run using Hapa's Place-It software. This method is totally secure and allows users total autonomy in the production of instant, high-quality print.
Fully compliant with the stringent validation criteria of the pharmaceutical sector, the Hapa 730 sets the standard for on-demand foil printing systems. The printing technology is based on a process similar to screen printing and uses a reliable high resolution master-foil system proven in operation worldwide for several years. The 730 is suitable for use with a variety of reel-fed substrates including aluminium foil, paper and labels, with a maximum width of 300mm.