Lining up a Track-and-Trace Solution
In January 2009, the Turkish Ministry of Health began requiring that pharmaceutical manufacturers serialize cartons with 2-D Data Matrix codes to enable track and trace activities throughout the supply chain.
|Uhlmann showcased a track-and-trace system for bottle and blister packaging lines at ACHEMA 2009.|
PharmaVision San. ve Tic. A.S., a contract manufacturing and packaging firm located in Instanbul, Turkey, shared its approach to meet the regulations with attendees at April’s European Compliance Academy. Alper Bigeçarslan, mechanical engineer, and Devrim Öcal, electrical and electronics engineer, both of the engineering department, detailed the coding activity as follows. The two were part of a 30-person implementation team from PharmaVision joined by an 18-person team from Uhlmann and Uhlmann’s center of excellence for vision inspection and lettering, VisioTec.
Established in 1954, PharmaVision produces a range of pharmaceuticals (except for lyophilized products) for 17 companies, many of which are multinational firms. PharmaVision produces about 9% of Turkey’s total pharmaceutical output.
On pharmaceutical cartons, PharmaVision applies a 2-D code with four informative lines (following an EFPIA proposal) as per Turkish law:
• GTIN (Global Trade Item Number; 14 digits).
• Carton serial number (maximum 20 digits).
• Expiration Date (6 digits).
• Batch/Lot Number (maximum 20 digits).
On the cases, a 2-D or a linear bar code is printed with two informative lines (following the EFPIA proposal):
• GTIN (14 digits).
• Batch/Lot Number (maximum 20 digits).
Next to the machine-readable code, the numeric human-readable portion needs to be present as a backup. This is required by law, and an example using a photograph of laser-marked carton flap can be seen on page 9. PharmaVision worked with Uhlmann and VisioTec to implement a plant-wide system for printing, inspecting, recording, and reporting codes. Installation began in December 2008; production started in January 2009, with validations extending into June.
|2-D Data Matrix codes encoding GTINs, serial numbers, lot codes, expiration dates, and lot/batch codes are being printed to meet Turkish Ministry of Health rules.|
On each packaging line, devices were added to either cartoning machines as an integrated marking solution or installed in-line on stand-alone checkweighers and to the bundlers, case packers, and palletizing units on each line. These included laser marking systems and intelligent cameras for detecting and evaluating laser print on cartons at the cartoning machine/checkweigher; an intelligent camera for reading bundled cartons; a label printer/applicator and a bar code scanner at the case packer, for either manual or automatic operations; and a label printer/applicator and a bar code scanner at the manual palletizing station.
In total, 15 lines were equipped with Track-and-Trace systems by Uhlmann. Besides four Uhlmann packaging lines, two other packaging machine suppliers’ lines were retrofitted with Uhlmann’s system.
Separate computers are dedicated to each packaging line for line control. All line computers are then connected to the main server. Bigeçarslan and Öcal explained that “each packaging line is able to work independently from each other. Lines are isolated, so they don’t interfere with each other.”
Data transfer between SAP and the Uhlmann track-and-trace system was established, as were modules to load customer and product master data, they added. These included a module to set up batch data, serialization, and data transfer between the line computers; a module to receive line data at the end of production, which then analyzes and inspects them; and software modules on mobile computers for dispatching, transferring, and other warehouse operations.
Data are delivered in XML formats to pharmaceutical company customers at the end of production and delivery. PharmaVision works with each customer to determine data storage and backup strategies.
Validation efforts first entailed installation and operation qualification (IQ and OQ) for all related program modules according to Category 5 classification in GAMP nomenclature. Next were IQ and OQ performed individually for the VisioMark, VisioRead, and Touch Control programs, all from Uhlmann. PharmaVision then validated general line performance tests such as communication of the two systems and correct use and repeated use of predetermined data.
Data exchange between Pharma-Vision and its customers as well as between PharmaVision and the Turkish Ministry of Health is limited to authorized personnel. Penetration tests are routinely performed, said Bigeçarslan and Öcal.
The benefits extend beyond regulatory compliance, PharmaVision has found. Recording of 100% packaging data from bundles, cases, and pallets can be accomplished. Statistical data from the packaging lines can be collected. Product and packaging component mix-ups can be prevented. Bad products can be sorted safely and in a manner that can be documented. Recalls may be easier.
Upstream machines may also be tied into the track-and-trace solution. Uhlmann demonstrated two track-and-trace-equipped packaging lines (one for blisters called BEC500 and one for bottles called IBC200) at ACHEMA. “The uniqueness of the full-blown T&T application here is the interface demonstrated with a MES system provided by Werum and to the ERP system from SAP,” explained Christoph Lehmann, Uhlmann. “Customers saw two different lines where each carton or bottle was serialized and aggregated on a case level. In case of Uhlmann’s new blister line BEC500, each blister was linked to its parent carton. Although not required to comply with current legislation, this principle links all machine production parameters to individual blister cards. Electronic data created by the Uhlmann Database System (UDS) tie in to Werum’s MES middleware, and the MES is tied in to SAP. ACHEMA visitors followed each step on terminal screens and saw in live time where product went and where data came from.”
Necati Sendan, head of Pharma-Vision’s engineering department, says that compliance with Turkish rules as well as with customer needs was critical, but so was minimal production interruption. “It was particularly important that our production process remained in operation during the integration and implementation of this project,” he explains. “It was also vital to avoid any unnecessary extensions or to influence the output of the existing packaging lines with the Track-and-Trace system.”
Once Turkey announced its deadline, Sendan and his team discussed options with the Ministry of Health, customers, and various manufacturers. PharmaVision chose Uhlmann’s solution because it “supplies its system from one source,” he explains. He adds that the track-and-trace system extends its utility beyond tracking: “100% monitoring of the packaged products has a positive effect on production performance.”■