For those who are not specialists in the pharmaceutical industry, the acronym “API” is unlikely to ring a bell. However, this term is widely used in this sector and its manufacturing generates an annual turnover of €2 billion in Spain, according to the Spanish Association of Fine Chemicals Manufacturers (AFAQUIM). API is the acronym for “Active Pharmaceutical Ingredient”. That is the ingredients, substances or active pharmaceutical ingredients that may eventually become a medication.
The manufacture of these compounds is the core business for companies in the pharmaceutical sector that develop, manufacture, and sell oral- and injectable-non-sterile APIs – patented and generics – for other pharmaceutical companies in regulated markets.
One such organization had several production facilities, but for its crystallization facility, the company had just introduced spray-drying technology, so the distributed control system (DCS) had to be upgraded. The company had to address two challenges: first, the solution that it was using was obsolete, so it had to implement an updated version; and second, it owned only a few licenses and needed to expand its number to meet the new requirements.
Batch management
An additional issue was that the updated version of the software did not allow a real migration to the new framework, automatically transferring all stored formulations and physical models. That isn’t a big challenge for a small number of formulations but, in this case, it was about a thousand. That’s a lot of work, when each of them must be checked, one by one, to confirm that the migration has been made correctly.
According to the company’s estimations, this checking process could have taken four months – far too long to be feasible – and it would require the summer holidays to implement the migration. Ultimately, this mandatory software upgrade would lead to a production halt and a high added cost.
Fortunately, this company had support from its trusted integrator of many years: ACK Logic. The two companies worked together to find a solution and decided not to upgrade to the new tool. Instead, they chose to migrate to Rockwell Automation FactoryTalk Batch. They undertook a feasibility study, in cooperation with Rockwell Automation experts, and determined that this solution was possible within the designated timeframe.
After many years of working with ACK Logic, there was a significant degree of trust between them. So, when the integrator assured them that they could complete the project on time, they did not think twice and chose to migrate to the new Rockwell Automation environment.
Quick and accurate
Three weeks in August were enough to finish the project. The reliability of FactoryTalk Batch, with its wide deployment in multiple industries, according to the ISA S-88 batch manufacturing standard, significantly reduced the implementation risks of the new system. FactoryTalk Batch enabled the formulations to be automatically converted and this dramatically reduced the implementation time and the project risks. Furthermore, communications between the new Batch system and the existing control system were solved with minor changes.
FactoryTalk Batch follows the S-88 model, which is the de facto standard for batch systems, and included open communications with control systems through OPC. Just a specific PLI between both systems was required to be programmed to assure the seamless integration of the batch software and the control systems.
“The formulations content and batch physical model migration don’t take a lot of time,” comments Eduardo Márquez, Technical Director at ACK Logic. “The real bulk of the work is in the checking of the FactoryTalk Batch points that operate the phase parameters, states, and commands. These checks are simple, since it is isn’t necessary to run the full sequence, but just review whether the parameters are set correctly.”
In addition to FactoryTalk Batch version 13, FactoryTalk AssetCentre was also used to implement Audit Trail and enable the conformity to 21 CFR part 11 in the batch system, both during the formulations migration and the plant operation. This software is the perfect companion for applications in regulated frameworks within the FactoryTalk suite.
Advantages for all relevant parties
This project has the additional advantage of being fully transparent to the production department. The aim was that, after the summer holidays, the production department wouldn’t even notice that the software had been migrated, so they could go on with their daily work as usual.
FactoryTalk Batch provides an efficient, easy-to-use operation interface. The batch controls conform to the S-88 standards that regulates the naming and actions in batch systems. This can be used with a specific application, Batch View, through any web browser, since it has an HTML5 client to access the web. The system is extremely easy to use, and from the point of view of the operations it enabled, accelerated the adjustment to the new tool and reduced the necessary training. As Márquez states: “FactoryTalk Batch is very similar to the tool we had installed, so no training time was required.”
FactoryTalk Batch also delivers additional features that improve the formulation security and management, formulation IP protection, version control or approval flow generation for new formulations by electronic signature. Márquez summarizes it: “The Rockwell Automation solution includes some features not delivered by the former software, such as enhancements regarding data integrity and user security system.”
Thus, according to Márquez, “The success of this project has been the migration to a FactoryTalk Batch framework while keeping the remaining parameters unchanged, without disruptions on the formulation production and maintenance within a validated framework.” For the customer, the completion of this project has been – in their own words – a relief. In fact, they have been working seamlessly in the new framework for more than six months now. What is more, they are aware that this can be implemented in other companies facing similar challenges, so they consider that this project can serve as an example to follow in the future.
