Affordable Solutions for DSCSA Requirements
The implementation of drug traceability is increasing and developing worldwide. Authorities that aim to protect their citizens from counterfeit drugs and their companies from loss of reputation, are signing official regulations. In the United States, the FDA also expects drug supply chain actors to take action for DSCSA requirements.
In our previous article we published information on DSCSA requirements and timeline. DSCSA, known as the Drug Supply Chain Security Act, was announced in November 2013. In accordance with DSCSA requirements, the serialization of drugs was completed in 2018. Today, an important step remains for the organized implementation of traceability: aggregation.
Aggregation Process in Accordance with DSCSA Requirements
In the US, drugs in circulation are serialized based on the product and shipping unit (bundle-shrink-overwrap, box, pallet). However, DSCSA also requires the aggregation process which means serialized units must be associated with a higher shipping unit and data reporting must be performed.
The non-profit organization HDA Research Foundation, part of the Healthcare Distribution Alliance, has revealed striking data in its research. In its report entitled “Health Services Facts, Figures and Trends (2022-2023), which includes analysis of the pharmaceutical supply chain in America, has been particularly emphasized that there is a lag in aggregation and reporting. According to the report, 40% of pharmaceutical manufacturers in America do not meet aggregation and reporting requirements. Given that there is only a short time until November 2023, solutions must be found in line with DSCSA requirements soon.
Innovative Approach to the Future: VISIOTT Aggregation Solutions
It is beneficial to look at systems that represent innovation for serialization processes before discussing aggregation solutions. The American pharmaceutical industry generally favors the use of bottled packaging. Products that are cost-effective and have strong service in bottled serialization provide advantages to manufacturers. In many countries, VISIOTT technologies are often preferred in traceability activities in bottled, boxed, vial, and flat-packed serialization. It is worth mentioning that VISIOTT’s 360° Bottle Serialization Station is also a pioneering product for the American pharmaceutical industry, like its other serialization technologies.
DSCSA requirements demand the completion of aggregation processes and the reporting of information for a successful traceability system. Aggregation, which creates a hierarchical data process through parent-child relationships between shipping units, must be carried out by high-performance systems. We are sharing with you VISOTT’s aggregation systems designed in accordance with DSCSA requirements:
Vertical Manual Aggregation Station
MAS-200 Manual Aggregation Station, which is prepared considering the aggregation needs of the industries in production, packaging, storage, and shipment operations…VIEW PRODUCT
Manual Aggregation Station
VISIOTT Manual Aggregation Station is able to read multiple 1D/2D codes of the serialized products in a big surface by a special vision system…view product
Automatic Bundle Aggregation Station
VISIOTT Automatic Bundle Aggregation Station, which has been designed in accordance with GMP guidelines, is an automatic solution for bundle aggregation operations. …view product
Semi-Automatic Case Packer with Aggregation
VISIOTT Semi-Automatic Case Packer automatically stacks the ready-to-be-packed serialized products on the line with a servo…View product
Semi-Automatic Aggregation Station
The station performs the aggregation process using data from serialized products in multiple layers in the case. While its compact design saves space in your companyview product
Aggregation Integration for Case Packer Systems
VISIOTT SASCP-100 Aggregation Integration for Case Packer provides solutions to aggregation needs by adding a vision system, label applica…Viev product
Notification and Management Operations According to DSCSA Requirements
VISIOTT software developed with consideration for all the needs of the American pharmaceutical industry, performs station management and notification operations according to DSCSA requirements. With VISIOTT software developed in accordance with the ANSI ISA 95 standard, you can achieve maximum data integrity and efficiency with minimum hardware resources. VISIOTT software easily integrates with ERP, MES, and Level 4 systems.
VISIOTT Line Manager can communicate and control in real-time with multiple hardware. Its configurable structure allows for easy addition of new hardware. VISIOTT Line Manager doesn’t need a Plant Manager (Level 3) data source for operation continuity, but it has been designed to quickly report results to the Plant Manager software.
VISIOTT Plant Manager is an innovative software that manages the entire traceability process from a single screen. The main function of VISIOTT Plant Manager is to assign work orders to lines based on information received from any EPCIS server or Level 4 solution, and to store serialization and aggregation data when the work order is complete. With the ability to track serial numbers throughout their lifecycle, VISIOTT Plant Manager makes it easier to monitor traceability operations.
VISIOTT Never Leaves You Alone
VISIOTT prioritizes its customers’ expectations in all stages, from production to sales, from installation to service. Communication takes place quickly thanks to its sales and service network located in many parts of the world. VISIOTT’s spare parts service is long-lasting.
VISIOTT provides 7/24 post-sales support to its customers and continues to serve in accordance with DSCSA requirements. You can contact us immediately to get information about VISIOTT and ask your questions.