Challenges facing the pharmaceutical industry
The pharmaceutical and biopharmaceutical industry is facing huge challenges. Strict quality and safety requirements make seamless documentation and absolute process reliability essential. At the same time, companies are under pressure to reduce production costs and boost efficiency.
The industry supports complex manufacturing processes that require maximum precision and flexible, reproducible production techniques. The key requirements of this industry are without doubt increasing standardization and optimization of the production processes and adherence to international obligations on supporting documents. In addition, rising energy costs, a shortage of skilled workers and the need for flexible production models for new treatment approaches are the major challenges. Further key issues include ensuring data integrity and protecting networked systems from cyber-attacks.
The solution to these tasks can only be provided by automation systems which control, monitor and analyze all the production processes in an integral and secure manner. Utilizing roughly 40 years of experience and its high-performance solution, Plant iT with MES functionalities, ProLeiT provides the pharmaceutical industry with the foundation for a sustainable competitive edge and helps develop its future readiness.
Forward-thinking solutions for the pharmaceutical industry
Are you currently dealing with the complex challenge of meeting the requirements of the pharmaceutical and biopharmaceutical industry and looking for a solution that:
- facilitates, safeguards and documents your processes,
- optimizes your entire value-added chain,
- increases the productivity and flexibility of your company,
- helps make your business more profitable
- and accompanies you on your journey to building the industry of the future?
With Plant iT, ProLeiT offers a high-performance platform that is specifically tailored to the extensive requirements of pharmaceutical production. Thanks to its modular and scalable architecture, the system easily adapts to specific processes and increasing capacities – both for greenfield and brownfield projects.
Roughly 40 years of experience have been invested in the development of our object-related and PLC-based process control system, which includes MES functionality. The integrated Audit Trail is particularly crucial for compliance with international standards such as FDA 21 CFR Part 11: It enables complete traceability of all changes – including user, end device and timestamp – both in the front end and in the database. This is supplemented by end-to-end material tracking and native creation of an electronic batch record with various options, such as worker guidance and review by exception. Together, these functions enable GMP and FDA-compliant processes.
Whether the focus is on digitalization, networking or compliance with the strictest regulations: Choosing Plant iT means embracing an open, integrated and future-proof solution that not only enhances current production performance but also gives you a competitive edge in a dynamic market.
Our customers
… and many more
Your contact for the pharmaceutical industry of the future
Verena Mersmann
Branch Leader Chemical & Life Science Business,
ProLeiT GmbH, Germany
E-Mail: proleitsales.request(at)se.com
Plant iT - the automation solution for the pharmaceutical and biopharmaceutical industry
With Plant iT, our in-house developed process control system, we offer an integrated, open and flexible platform for automating complex production processes in the pharmaceutical and biopharmaceutical industry. The industry-specific architecture combines in-depth process knowledge with state-of-the-art IT technology and is suitable for new installations, expansions or the migration of existing systems.
From active ingredient production and biopharmaceutical processing to filling and packaging in line with the strictest GMP regulations and guidelines – Plant iT ensures maximum transparency, efficiency and quality. The integrated MES functions enable seamless documentation and automatic creation of the electronic batch record, while end-to-end material tracking ensures full compliance with international standards such as FDA 21 CFR Part 11.
In an industry where quality and speed are crucial elements, Plant iT helps digitalize processes, speed up batch approvals and maintain data integrity. Our extensive experience and long-standing collaboration with plant suppliers ensure that we deliver solutions that connect and optimize your production processes, helping you meet the demands of a dynamic, regulated industry.
Current product highlights
With Plant iT, we provide a high-performance solution for the pharmaceutical and biopharmaceutical industry. Our developers are constantly expanding our product portfolio with new products and innovative features designed to make your production faster, more transparent and safer.
Batch Orchestration
The Plant iT Batch Orchestration System (BOS) facilitates the management, monitoring and control of batch processes. It offers a wide range of options for interacting with running orders: Recipes can be dynamically optimized, expanded and standardized at any time.
Weighing Assistant
ProLeiT's Manual Weighing System (MWS) serves as an intelligent weighing assistant, ensuring the clear processing of bills of material by visually and reliably guiding operators through the weighing process.
Alarm System
Also stay informed from afar: The Plant iT Messenger sends critical alarms via SMS or email and ensures rapid response thanks to escalation management. All messages are fully recorded.
Audit Trail
The Audit Trail functionality is the key to compliance with FDA 21 CFR Part 11: It documents every change – including user, end device and timestamp – and ensures absolute transparency. Supplemented by material tracking and electronic batch records, our system meets the highest GMP and compliance standards.
Take a look at the many added values Plant iT offers
Plant iT is the modular process control system from ProLeiT GmbH and has been deployed throughout the process engineering industry in more than 110 countries for over 37 years. From operating data acquisition, process control technology, liquid handling and batch systems to functions for complete, location-independent production management (MES) and integration of ERP, LIMS and maintenance systems – Plant iT enables continuous control and monitoring of all these processes.
Thanks to a central engineering environment and optional modules, Plant iT can be expanded flexibly to meet various needs. Plant iT complies with the principle of "parameterization instead of programming". This means that individual programming is essentially replaced by the parameterization of technical and technological functions. Plant iT's system architecture offers maximum flexibility for changes, even during production, without the need to shut down operations. This time-saving approach offers our customers a distinct competitive advantage.