Biotech and pharma companies are looking to intelligent, connected operations as a way to remain competitive and better serve those who rely on their products.
The global pharmaceutical industry is facing increasing pressure to get drugs to market faster, while maintaining compliance and data integrity. The demand for targeted, smaller volume pharmaceuticals and personalised medicines is growing and therefore, driving operations away from large-scale bulk production to multiproduct facilities that require complicated batching, frequent changeovers and meticulous tracking.
Among the enabling technologies underpinning the ongoing digital transformation in industrial process control within pharma and food production, MES software is one of the fundamental building blocks. MES is capable of standardizing production processes, while integrating them and rendering them more homogenous, with a positive impact on corporate organization and employee productivity, all without any negative effects on production processes.
MES improves pharma compliance
Zhejiang Medicine Company (ZMC) is a global bio-pharmaceutical manufacturing and sterile-packing industry expert, an innovative pharmaceutical model in China’s export business. The company recently invested in a new MES system to more efficiently and cost-effectively produce antibiotic on FDA’s drug-shortage list.
The sterile powder for injection project was Zhejiang Medicine Company's first MES application pilot project. To meet the strict regulatory requirements in Europe and America, Zhejiang Medicine Company chose Rockwell Automation as its strategic partner, using PharmaSuite to establish a Batch management as the core of the MES system to ensure compliance and efficient production.
Replacing traditional paper records and document management, PharmaSuite helped achieve the goal of 100 percent paperless production. After the PharmaSuite production order is issued, the operator picks material from the staging room. By using digital labels, PharmaSuite helps to achieve traceability and prevent mistakes or cross contamination. The digitising of the manufacturing process, coupled with the integration of the warehouse management system and laboratory information management system, enables ZMC to produce electronic batch records.
Through integration of process automation systems, PharmaSuite captures real parameters and generates real-time reports. Application of Rockwell Automation mobile solutions facilitates the scanning of digital label of equipment and material and uploading the related report to the MES by using global tablets.
PharmaSuite manages the production equipment and intermediate fault equipment status by scanning the digital labels on equipment or material, PharmaSuite confirms the correct equipment to be used and ensures the production process is under control. Real-time alarm monitoring of the production process ensures that abnormal situations can be attended to in a timely manner.
The PharmaSuite recipe design function is compliant with the ISA S88 standard providing a modular, graphical and configurable solution. Using the latest virtualization technology, the MES and SCADA systems are three physical servers – greatly reducing hardware and maintenance costs while improving the IT management efficiency.
PharmaSuite accurately and completely stores the real-time data and production process information in the database and creates a back-up. Access management and audit trail capability helps to ensure that all data creation, entry and modification are controlled and traceable.
Replacing the traditional paper records and documents management, PharmaSuite achieved 100 percent paperless during the production process. The new solution also enhanced quality by automating data handling, reducing the risk of errors such as misinterpreting or incorrectly entering data. In addition, the PharmaSuite MES reduced costs. These cost savings include five to 10 percent labor savings; 46 to 75 percent reduction in batch product review cycle time; and 50 percent reduction in management review cycle time.
The new MES enabled ZMC to thrive in a highly competitive global pharmaceutical industry while remaining compliant in an ever-tightening regulatory environment.
Digital transformation: End-users’ perspectives
At a recent round table discussion in Italy titled “The Digital Transformation: Challenges and Opportunities for the Manufacturing Industry,” Rockwell Automation was able to discuss the challenges of digitalization of production processes. And, above all, how do they attribute new technological and business values to these challenges.
Luca Pezzano from IBI Lorenzini, Alessia Crivelli from Farmaceutici Formenti - Grünenthal, Davide Cascella from Idea 75, Tiziano Petrucciani from Molteni Farmaceutici and Sigfrido Velicogna from Ibsa Farmaceutici Italia – in collaboration with the Rockwell Automation Italy team – are working in the direction of 4.0 production systems, through the implementation of MES, serialization solutions (based on standard PharmaSuite software) and process technologies in their various facilities across the country.
MES software was defined as one of the fundamental building blocks by Idea75 and Farmaceutici Formenti (Gruppo Grünenthal). In Molteni Farmaceutici and IBI Lorenzini, serialization was first deployed as a regulatory requirement but was then progressively transformed with the adoption of PharmaSuite software from Rockwell Automation in order to implement new process management practices within their facilities – maximizing and optimizing the collection and analysis of data along the entire supply chain.
The importance of the integration, management and integrity of data along the entire supply chain is a fundamental aspect for IBSA Farmaceutici Italia too.
In this and other examples, process technologies, logical control of production lines and environmental condition monitoring must guarantee maximum stability and safety along with scalability and improved interactions with line operators.
For pharmaceutical producers, it is essential to have stable and scalable platforms that not only work together to prevent data loss, but also facilitate data analysis and comparison as quickly as possible.
Based on the feedback from these end users, it is obvious that those who are seeking to create Smart Industry 4.0 production processes must also deploy ever more integrated, rapid and slim-line data management using “cognitive” automation process.
As these Italian end users have confirmed to us, in the world of Industry 4.0, there are and always will be improved forms of standardization and open, integrated platforms.
To continually drive this digital transformation, it is therefore necessary to invest in software and technologies that render data and information more useable and transferable to those who truly need them, with a closer connection between IT and OT, providing support for decisions without precedents.
Above all, it’s important to remember that digital transformation involves three fundamental elements: people, processes and technologies.