What is ISA-88?
ISA-88 is a standard introduced by the International Society of Automation. This standard aims to provide guidelines for the design and structure of batch control systems to ensure a common understanding among manufacturers. It details regulated data structures for efficient communication between batch components, and it defines notable terminology within batch control.
The ISA-88 standard also examines batch control system architecture from a physical and functional standpoint. The physical model looks at the hierarchal structure of data communication and control equipment. A process is made of stages, which consist of operations that require actions.
The functional model examines the different types of control — scheduling, recipe management, regulatory control, sequential control and safety interlock systems. How do these control types interact, and what does each need to succeed? Ultimately, ISA-88 wants to outline the necessities for an efficient batch control system. In deconstructing its different aspects, ISA-88 defines all necessary components and processes.
The challenges of process automation
One of the biggest challenges in the pharmaceutical sector is to combine production flexibility by using validated automation systems in compliance with current GMP regulations.
Through an ISA 88 batch system it is possible to divide the elementary control functions of the devices that make up the equipment (which we will call phases) from the sequences of phases necessary for production (which we will call recipes).
In this way it is possible to validate the single phases only once. Each product will then have a different recipe, composed of a different sequence of phases. With this approach only the recipe will be validated, not the phases.
It will therefore be possible to make different products through different recipes, drastically simplifying the validation phase.
Through the ISA 88 batch control it is therefore possible to maximize the flexibility and efficiency of the installation while guaranteeing validation.
Paper recordkeeping
Outdated processes typically rely on more human intervention. While having a dedicated team on your product line can be a great addition to your operation, certain jobs need machine automation. If you record data on paper, you're running into potential errors. Paper records can lead to lost files in the long term and reduced efficiency. A human can only track so much in a process.
Missing data
When you count on a person to track data, they're likely to miss information. This problem isn't necessarily a result of negligence, just human error. Missing data will affect your information on your batch control system and hurt your productivity. Automated machinery can help you fill in the gaps that humans miss.
Data Acquisition and Reporting
During the execution of the batch process it is essential to acquire the critical process parameters and detect exceptions that may occur.
It is therefore essential that the system includes historian, deviation detection and audit trail functions.
At the end of the batch it is necessary to generate a report that clearly presents all the useful information to understand the process progress and recognize any exceptions.
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zenon Batch Control is ISA 88-compliant and separates the process from the operational level
Test and change recipes without programming knowledge
Process managers can intuitively create and adapt recipes via a graphical user interface without programming knowledge. He can select a simplified editing mode in form of a “Matrix view” or a more powerful Procedure Function Chart (PFC).
The test of the recipes is simply carried out through the "Test" mode where it is possible to verify the execution of the recipe and any abnormal conditions.
Scalable production system
Thanks to the scalability and flexibility of Batch Control, you can both control individual processes and the entire production system in zenon. Extension of the equipment is no problem either. For instance, start with an isolated process and gradually expand the system to one or several batch processes and then to a homogeneous and fully integrated environment – including a cloud connection, reporting, mobile solutions and much more. Thanks to the numerous interfaces, you can connect various hardware and software.
zenon is open. Thanks to the various drivers, you can connect many different industrial systems, equipment, machines and measuring equipment, no matter which manufacturer and irrespective of whether it already exists or is new. It provides you with a holistic view of the entire production process.
Even existing control and monitoring systems can be integrated into zenon and thus, enhanced because zenon adds technologies and functions to an existing system.
Flexible production capabilities
Using zenon for batch production is also perfect for efficiently producing small quantities of various pharmaceutical products with one set of equipment. As soon as the system is validated once, you can change recipes on this basis without the need for revalidation. This allows for a quick and economical conversion to each new product. Result: Your production becomes more flexible and profitable.
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zenon complies with international regulations such as FDA 21 Part 11 and EU Annex 11
Quick reporting
Thanks to the full integration of the batch process, production data is simultaneously recorded and analyzed. This provides the necessary reports for immediately approving the batch after the process has finished. The interplay between automated and manual processes is not an issue with Batch Control in zenon. Staff can manually enter parameters in the system while the automated processes are connected via interfaces. This lets you manually and automatically analyze the collected data in parallel. Operators benefit from a graphical interface with high usability which, for example, is operated via a touchscreen on tablets.
You furthermore benefit from analysis tools and numerous reporting options in zenon. By doing so, you increase the benefit and get even more out of your existing system.
MES, ERP system and batch execution integration
zenon uses native interfaces to integrate with MES or ERP systems. This allows for a smooth flow of data between IT systems and batch execution, making manual intermediate steps redundant. It creates a homogeneous environment, where batch production can be executed securely and efficiently.
Compliance with regulations
zenon complies with international regulations such as FDA 21 Part 11 and EU Annex 11. Compliance is achieved only via configuration and without programming, as specified by Category 4 of the ISPE GAMP5 guideline. Configurability not only allows for compliance but also makes it as simple and efficient as possible. This saves time and costs during implementation, maintenance and expansion and prevents errors during project configuration.
zenon Batch Control is ISA 88-compliant and separates the process from the operational level.
Contact COPA-DATA
for ISA-88 process automation
zenon is the software you need for simplified ISA-88 process automation. With flexibility in process design, high-grade security and ease of use, zenon offers all the tools you need to meet the ISA-88 standard. Relieve your workers of the high stakes data reporting and allow them to focus on efficiency while you change the way you handle your batch control system.
With over 30 years in the industry, COPA-DATA has the software knowledge to provide a reliable product. We continually improve zenon to ensure it meets the necessary logic and algorithms for ideal function. To learn more about zenon, contact us today.
The high level of risk present in the pharmaceutical industry has made many manufacturers hesitant to move away from paper documentation and embrace the total digitalization of the manufacturing plant. As drug patents expire, however, production efficiency becomes increasingly important. At COPA-DATA, we have developed our pharmaceutical manufacturing software zenon to help companies overcome industry challenges and optimize their processes using innovative technology.
