Accevo , a leading provider of production optimisation solutions, has entered into an agreement with ALKALOID, a leading pharmaceutical company in North Macedonia, to implement MES (Manufacturing Execution System) with EBR (Electronic Batch Record) solutions. These innovative systems, collectively known as AlkaMES, aim to enhance the production process, improve efficiency, and ensure compliance in the rapidly evolving pharmaceutical industry.
Accevo ‘ systems are designed to enable pharmaceutical companies to fully leverage advanced machinery, production lines, and employees. By transitioning to paperless operations, the modern pharmaceutical industry saves valuable time for operators and ensures the accuracy of documents. Real-time data collected from specialised production equipment allows managers to analyse the entire process and continuously enhance it.
The implementation will be carried out in multiple phases. The first phase, a pilot project, will focus on solid and packaging processes, including lines and machines such as packaging, blender, tablet press, and coater. Full connectivity and OEE (Overall Equipment Efficiency) monitoring will be established, along with integration with systems like SAP. The first phase will focus on preparing a full Master Batch Record (MBR) and generating EBR with digital signatures. In the second phase, the pilot project will be extended to the remaining lines and machines in solid and packaging processes, with the Shopfloor Warehouse Management System (WMS), including containers management, microstops monitoring and rooms management. The third phase will roll out the pilot project to all lines and machines involved in cephalosporins, semi-solid, and liquids filling and packaging processes. The phased implementation approach ensures a systematic deployment of the MES and MBR&EBR solutions, optimising ALKALOID’s production processes and paving the way for enhanced efficiency and compliance in the pharmaceutical industry. Each phase will be validated by Accevo so ALKALOID can work with the system on production. An important aspect of implementation is Generic Master Batch Record. The GMBRs reduce the number of MBRs by grouping processes that always have the same workflow and just differ in their parameter settings. This is especially true in the field of packaging, where there are numerous MBRs due to the numerous product versions, such as the number of pills, the language version of the package inserts, or the container to be used.
The implementation of the MES and MBR&EBR solutions is expected to bring numerous benefits to ALKALOID. Increased process efficiency, resulting from enhanced routing accuracy, is estimated to achieve a 10% improvement. Quality Key Performance Indicators (KPIs) will improve by 8% due to optimised production process control, online parameter monitoring, and tolerance management. The time required for batch control will be reduced by 35% thanks to Electronic Batch Record implementation, which includes data structuring, initial system checks, and automated data collection from lines, machines and IPC devices. Additionally, the system’s Operator’s guide will reduce errors and deviations by 25% by guiding operators through processes and minimising potential errors.
The implementation of Accevo ‘ MES and MBR&EBR systems will not only optimise ALKALOID’s production processes but also contribute to a fast Return on Investment (ROI). The collaboration between Accevo and ALKALOID represents a commitment to innovation, efficiency, and quality within the pharmaceutical industry.
About Accevo : Accevo is a leading provider of production optimisation solutions, specialising in MES and EBR systems. The company offers comprehensive solutions to businesses, enabling increased efficiency, productivity, and competitiveness in the market.
About ALKALOID AD Skopje: ALKALOID is a renowned pharmaceutical company recognised for its excellence in producing high-quality pharmaceutical products. With a focus on continuous improvement, ALKALOID strives to optimise its production processes and deliver exceptional products to its customers.
More about the project: AlkaMES Project
Digitalization in pharma is not a choice, it is the only way forward. I believe with our knowledge and commitment and IT expertise from Accevo we will create a great MES that will make our lives easier and increase our efficiency.
Maja Lazarova, Head of production at ALKALOID AD Skopje
I couldn’t be more thrilled about the opportunity to work with the ALKALOID team
Bartłomiej Bieniek, Program Manager
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