Industry Focus Chemcials & Pharmaceuticals
Pharmaceutical contract manufacturer, Sanico NV, has increased tablet inspection at its Turnhout facility in Belgium to 100% with the installation of four INSIGHT PH metal detectors from Lock Inspection Systems
he investment is part of Sanico NV’s continuous drive to improve quality standards for its global customer base. Wim Roelants, the company’s production manager, commented, “By installing an additional four metal detec- tors in our tabletting operation, we now offer the reassurance of contaminant inspection across our entire tablet range. This is a key part of our strategy to raise the bar in terms of the quality standards offered to our customers. “Lock’s INSIGHT PH unit
impressed us with its highly intuitive user interface and streamlined GMP design which offers easy disassembly for cleaning.”
The four INSIGHT PH units are inline installations for metal contami- nant inspection during compression. As the tablets leave the press, they pass through the units in containers
Boosting tablet inspection capacity T
Above: Lock
Inspection installed four INSIGHT PH metal detectors at Sanico NV
before moving to blister packaging. Tablet size ranges from 3-25mm in diameter and total output is between 30,000 to 300,000 tablets per hour. James Chrismas, marketing man-
ager at Lock Inspection Systems, added, “The units operate 24 hours a day, five days a week, in a con-
Lock Inspection Systems
www.lockinspection.com T: 0161 624 0333
Combating falsified medicines
U regulators are ushering in a new era of pharmaceutical manufac- turing and distribution compliance which is expected to tighten up safety within the supply chain and eliminate falsified medicines. In adhering to these regulations companies need to factor in the importance of machine vision, which is the only way to read and ver- ify the four key data elements proposed by the European Stakeholder Model (ESM)* if they are to meet the 2017 deadline. Faced with the growing and substantial threat of falsified medicines penetrating the European market, ESM has developed an end to end medicine ver- ification solution, consisting of four key data elements, to combat the entry of fal- sified medicine. This verification system plays a pivotal role in aiding manufactur- ers to adhere to the 2011 EU Falsified Medicines Directive (FMD) which requires manufacturers to apply safety features to verify the authenticity and identity of indi- vidual packs of medication, which will be mandatory by 2017. To drive implementation of the FMD, a consultation has been undertaken to define the characteristics and specifications of a unique authentic pack identifier. While these findings, which will come under a Delegated Act, are not anticipated until later this year, it is highly predicted that it will include the adoption of a 2d DataMatrix barcode on each pack of medicine. Furthermore, the verification sys- tem proposed by the ESM features a 2d DataMatrix code carrying four key data elements which will also be required in a human readable format (manufacturer product code, randomised unique serial number, expiry date and batch number) and the definitive way to read this system is through machine vision. Through the incorporation of this information the 2d DataMatrix is forgery-proof so
E
that each individual pack can be tracked from point of manufacture through to distribu- tion (end to end) using scanners, software and databases allowing pharmacies to verify the authenticity of the medicines at the final point in the supply chain, namely dispens- ing to the patient. By simply scanning the barcode on the packaging, any unregistered code will immediately alert the pharmacist to the possibility of a falsified product. Traditionally human readable code and data encoded within barcodes has
remained fixed between batch runs of pharmaceutical products. While every phar- maceutical pack has been required for many years to carry variable data in some
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form, the directive now requires unique data for each pack rather than each batch, as in the past. With so much detail to get right, there will inevitably be significant impact on pharmaceutical manufacturers which are printing and producing packaging. Certainly many wider implications and preparations will be needed involving data management, pack artwork, data quality, and internal organisation, processes and communication. Much of the coding equipment implemented today is not capable of 2d DataMatrix serialisation and many manufacturers will need to upgrade their
coding kit. However, a significant challenge arising from the proposed 2d DataMatrix code is with regard to the data management of the randomised unique serial number and the synchronisation of data between the printing device and verification system. A resolution to this would be the integration of flexible vision solutions which are built on IPC technology to provide the flexibility to cope with a wide range of data manage- ment requirements and allow for interfacing with third party devices such as printers. These superior specification vision solutions can interface with high level production management software to request the data required and verify the unique serial num- ber, whether through database integration or simple manipulation of .csv data files. Although the final details of the Delegated Act have yet to be formalised, vision solutions suppliers need to provide pharmaceutical packaging manufacturers with a flexible technology platform, allowing them to adapt to the changing market requirements to remain compliant and ultimately ensure patient safety. It will no doubt be a steep learning curve in becoming fully compliant, but there is help in the form of counsel from industry suppliers. The ability to meet the requirements of FMD is imperative for drug manufacturers and upgrading machine vision systems to meet these requirements is an essential step in the process. The direction and shape of the post 2017 EU pharmaceutical supply chain is clear - if these changes are not acted upon there is a real danger that
some pharmaceutical companies will not be able to trade in post 2017 Europe. * The European Stakeholder Model (ESM) is a partnership of organisations involved in the pharmaceutical supply chain. The ESM partners have joined forces to develop a safe, cost effective and partnership-based pan- European medicines verification system to combat falsified medicines.
Omron Electronics
www.industrial.omron.co.uk T: 01908 258 253
Enter 206 JANUARY 2014 Automation
trolled and monitored clean zone production environment to European Pharmacopeia standards - so design, efficiency and perfor- mance of
the metal detector units
are all key. Following a two week trial of one unit, Sanico was confi- dent that our INSIGHT PH units would meet its stringent manufac- turing requirements.” Designed for increasingly demand-
ing pharmaceutical standards, Lock’s stand alone INSIGHT PH metal detec- tor combines core technologies with features to deliver tangible benefits to manufacturers of tablets and cap- sules. Highly resistant to vibration, the integrated digital search head and OPTIX detector management soft- ware guarantee detection and rejec- tion of minute metal fragments, while maintaining high productivity and sensitivity to all metals.
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