Life Sciences and Pharmaceutical
iFIX, Proficy Batch Execution
Proficy HMI / SCADA
This is an excerpt of an article originally published in Portuguese by Ronaldo Luis da Silva, Maintenance Engineer, Aché Laboratory; Moacyr Souza Júnior, Account Manager, Aquarius Software; and Sidnei Kolano, Technical Manager, Link Automação.
Aché Laboratórios Farmacêuticos S.A. is a 100% national capital company. Along its trajectory of more than four decades, Aché has consolidated itself as a dynamic company by establishing strategic commercial partnerships, inside and outside the country, for its expertise in similar medicines, management of a mature portfolio, knowledge of the Brazilian consumer market, and for the continuous development of products and services, in order to meet the needs of health professionals and consumers, providing health and well-being to the population.
With around 3.5 thousand employees, it has three industrial plants. The largest of them, located in the municipality of Guarulhos, in Greater São Paulo, also houses its administrative headquarters. The second is installed on Avenida Nações Unidas, south of the city of São Paulo, and the third in Goiás, with the acquisition of 50% of the pharmaceutical company Melcon, specialized in the production of female hormones.
In its strategic direction, to operate as a complete solution company, Aché operates in the three key segments of the pharmaceutical sector: Prescription, Generics and Non-Prescription Drugs (MIP). It maintains a broad portfolio, with more than 250 brands marketed in approximately 600 presentations.
Scenario prior to the implementation of the system
Within the liquid unit of the Guarulhos plant, there were numerous products to be manufactured and a great variability in production times. All steps specified in the prescription of a drug were performed manually. With great difficulty in stipulating a production delivery time for a given batch, previous batches were analyzed, and a difference in execution times was found between the handlers responsible for producing batches of the same product.
In order to standardize the operating times until reaching the final product, a study was developed to verify the need to implement a tool capable of automatically managing the batch production process.
After this analysis, it was found that with the reduction of manual interventions in the process, it would be possible to achieve a forecast closer to reality regarding the delivery time of a batch.
With an implementation date scheduled, the automation system of the liquid unit had the challenge of creating a standardized platform, based on international software development standards and in compliance with the main regulatory agencies of the pharmaceutical sector in the world.
To overcome the challenge, it was necessary to obtain a software platform that was built under the norms of the pharmaceutical sector, facilitating the adaptation of the production process and the personnel involved in the production of medicines to the new system.
In addition, the characteristic of being built under industry standards would facilitate the process of validation and qualification of the new computerized system.
With the choice of the Proﬁcy product line from GE Digital, through its distributor Aquarius Software and implementation by Link Automação, all the resources available in the S88.0 construction standards, have earned their reputation and, with the property of building libraries, the classes, phases and operations of the system, it was possible to implement a complex project, in a very short period of time and with great quality, eliminating the risk of building errors.
The first step in implementing the system had already been taken successfully, but the software platform needed to be documented according to the requirements of good manufacturing and documentation practices GAMP and FDA 21CFR part 11.
As the platform was built under the guidelines of the pharmaceutical market, the software adapted perfectly to the resources requested by GAMP and 21CFR Part 11, making the documentation, testing and correction system a process capable of being accurately measured and with perfect adherence to regulations.
As the validation and qualification process in the pharmaceutical industry is rigorous and delicate, all settings must be documented with excellence in all stages. At this stage of the project, if the software platform is not fully compatible with the norms and good practices of the sector, construction errors or problems of adaptation of the new system to the production environment will be found, condemning the computerized system to failure.
With the second step successfully completed, it was necessary to create the recipe models (Procedures) that would be used in the new computerized system and plan the installation of the system.
The creation of the solution based on the S88 standard allowed the system to use all the physical resources installed in the production unit, transferring these resources to the drug production recipes.
At the same time as the recipes were created, another work team performed the tests of the recipes already implemented, validating the entire system in an almost parallel work format. The programming and connectivity resources with databases and objects provided by the software platform were fundamental for the success of the recipes to be achieved. In addition, the native Client / Server features and the ability to fully adapt to the operating system and the distributed architecture, with different levels of security, allowed the implementation to be carried out with several work teams at different levels of the system. With electronic work messaging resources, the construction of product recipes reached the highest quality standard and, at the same time, the operator's proximity to the system, facilitating the development and acceptance of the solution by the operation team.
In this stage of the project, the construction, documentation, testing and implementation steps had been successfully completed and the system needed to guarantee the return on investment and provide resources to optimize the process, through the analysis of the implemented revenue structure.
In order to resolve this issue, total compatibility with the S88 standard was essential, because through a detailed study of the recipe structure, it was possible to decrease the number of steps, reducing the software cycles and automatically shortening the production time for each product.
The recipes were created using the SFC (Sequential Function Chart) language, which facilitates the organization because it graphically describes the sequential execution behavior, facilitating the visualization of the actions that will be performed and the transition conditions that will be necessary for the next step to be initiated.
The availability of the system was guaranteed with a solid hardware and software redundancy structure, which offers the necessary security for the production process. With redundant database servers and supervisory systems, several process data recording locations, the system continues to operate even if many hardware items fail at the same time.
Currently, the data generated by the management system is stored and traceability reports are consulted by the supervisors of the production unit and quality assurance department, to monitor the quality of the production.
Results with the implementation of the management tool
With the implementation of this system, which is easy to operate, where it is possible to monitor in real time all the resources that are being used and the products that are being manufactured, there was a significant increase in production capacity.
The use of electronic signature in all interventions carried out in the process with configuration of hierarchical levels ensures the registration of events and system actions, avoiding interventions by unauthorized people and ensuring that operations are being carried out consciously, with the user's confirmation and password. A typical example is the release of recipes for production that are carried out only by the Quality Assurance area.
With the reduction of human interventions, it is possible to define the start and end times of production much more effectively, considering the product and the lot size, guaranteeing precious information for an efficient and dynamic management of the production process. In addition, the possibility of human error has decreased, ensuring standardization and execution of all steps in the same sequence and time interval.
Due to the system being based on the ISA-S88 standard, its maintenance is easy to understand, saving time and technical resources, and ensuring a longer time of availability for production.
Read the article “Implementation of Batch Tool in Pharmaceutical Industry,” by Ronaldo Luis da Silva, Maintenance Engineer, Aché Laboratory; Moacyr Souza Júnior, Account Manager, Aquarius Software; and Sidnei Kolano, Technical Manager, Link Automação, originally published in Portuguese in InTech
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