New Labeling and Verification System Helps Pharmaceutical Companies Comply with Stricter Worldwide Serialization Regulations

METTLER TOLEDO PCE’s T2620 Helps Pharmaceutical Sector Meet Requirements of the Falsified Medicines Directive

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New Labeling and Verification System Helps Pharmaceutical Companies Comply with Stricter Worldwide Serialization Regulations
New Labeling and Verification System Helps Pharmaceutical Companies Comply with Stricter Worldwide Serialization Regulations

METTLER TOLEDO PCE has launched a labeling and verification system that will help pharmaceutical manufacturers and contract manufacturing organizations (CMOs) meet stricter global serialization regulations. The new T2620 is a compact system for the Track & Trace labeling¬ of cartons in accordance with the Falsified Medicines Directive (FMD) in Europe, the Drug Supply Chain Security Act in the US, and other global regulations.

“We are bringing the T2620 to market in two model variants – for cartons with a width of up to 150 mm and those with a width of up to 250 mm,” says Reinhold van Acke-ren, Head of Marketing at METTLER TOLEDO PCE. “With both model variants, we are able to guarantee pharmaceutical manufacturers and CMOs fast delivery and in-stallation of the system with our standard configurations – increasingly important over
the coming weeks and months as the FMD deadline of February 9, 2019 approach-es.”

Flexible Solution
The T2620 system supports the Track & Trace-compliant printing¬ of data such as se-rial numbers, batch numbers, expiry dates and static product identifiers on the car-ton, together with a datamatrix code containing the same serialization information. The combined system then verifies the accuracy and¬ quality of the printed infor-mation using a camera.

The T2620’s compact design saves valuable production¬¬ space and the system can be easily integrated into new production lines or added to upgrade¬¬ existing¬¬ ones. The T2620 is compatible with all METTLER TOLEDO PCE software for data man-agement, serialization and aggregation, such as PLM and PLM Direct, and can be seamlessly integrated into existing ERP environments via the PCE Software Suite.

Minimal Equipment Setup Time, Maximum Availability
The T2620 system features the latest frame technology from the METTLER TOLEDO C33 Series of checkweighers, making it incredibly stable and vibration-free. It also ensures precise mechanical product transfer and a smooth and¬ secure product flow when interacting¬ with systems that are optimally aligned with each another. The T2620 takes the cartons requiring printing¬ directly from the cartoner by means of a transfer unit. Thanks to the convenient¬ user interface on the terminal for calling up stored¬ product data and the easy-to-use manual setting options, the system can be quickly adapted to new products and carton dimensions.

Inline Validation and Product Rejection
The printer unit prints the serialization data and codes on the front or rear side of the cartons. Cartons with data successfully¬ verified by the camera system are stored in an internal database with the status ‘commissioned’. The logs created at the same time serve as the proof of quality required by GMP. Cartons that do not meet the re-quirements of ISO 15415 during the inline validation of the print quality of the data matrix
code, or that are otherwise defective or illegible, are ejected into the reject bin by means of a precision air nozzle or an optional pusher.

Model Variants
The T2620 system has a belt speed¬ of up to 80 meters per minute for throughput¬ rates of up to 400 cartons per minute. While the T2620-150 model variant supports the processing of cartons¬ with a width of up to 150 mm and a fill weight¬ of up to 300 g, the T2620-250 model provides a solution for cartons with a width of up to 250 mm and a fill weight of up to 1100 g. Both models are available immediately.

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