2023 Requirements of DSCSA

The pharmaceutical industry of America completed the serialization of all pharma projects in 2017-2018. The next most aggressive challenge is to ensure that serialized drugs are traceable within the supply chain. Serialized drugs need to be aggregated to make sure that the drugs are traceable in the supply chain. In addition, pharmaceutical manufacturers are required to install a VRS (Verification Router Services) system.

Aggregation for full compliance with DSCSA Timeline

Pharmaceuticals on the US market and transport units that integrate these drugs (container case, bundle, pallet) have been serialized. But the DSCSA Timeline wants hierarchical aggregation of transport units. What does this mean?

In short, aggregation in the pharmaceutical industry is defined as the virtual connection of serialized transport units and serialized drugs within them. The most common method for this virtual connection is to create hierarchical data with a parent-child relationship. When this data is associated with the serialized transport unit, the aggregation is complete.

Bottle Serialization and Aggregation in accordance with DSCSA Timeline

Serialization in bottles used in the American pharmaceutical industry is carried out on the label on the bottle. Thermal printers integrated into labeling machines are the most commonly used method to meet this requirement. Applying a helper code to bottles to meet the aggregation requirement and matching this helper code and the code on the bottle is a common method. The most common method for matching the helper code with the code on the body is 360-degree reading. After matching, the aggregation process can be easily completed by reading the helper codes on the bottom or cap of the bottles collectively.

For VISIOTT’s bottle serialization and aggregation line offering in accordance with DSCSA timeline requirements, please see the specifications of the stations below.

Carton Serialization and Aggregation in accordance with DSCSA Timeline

Cartons are easier to serialize than bottles. Because printing is done on a flat floor, and there is no need for a helper code for aggregation. Codes can be read collectively with a high-resolution camera.

There are also many technological alternatives to printing 2D code on cartons. Thermal Inkjet and Laser are the most commonly used technologies. Especially with advanced thermal inkjet technology, almost any surface can be printed with water and solvent-based inks. Thanks to our high-speed camera technology, you can perform 2D code control at 600 box minutes.

For VISIOTT TPS’s carton serialization and aggregation line offering in accordance with DSCSA requirements, please see the specifications of the stations below. You can contact our sales team for more detailed information.

Author: Emre ÖZDEN