close
close
close
A new level of detail in the SCADA system: A European pharmaceutical company secures the processes on a fill-and-finish system with an isolator and two connected freeze dryers and documents the product quality automatically. In addition to data transparency for the entire line, the SCADA system also offers comprehensive protection for the company itself.
SCADA means Supervisory Control and Data Acquisition. Functions like glove testing systems and checkweighers, which exclusively monitor processes, are usually included in a SCADA system. This also applies to isolator data due to its protective, respective barrier properties, as well as freeze dryer temperature data.
However, the customer sought even more. Optima project manager Daniel Keck reports that for the first time, data from the material transfer lock is now being imported into the SCADA system. Thus, even system data that has a very low probability of influencing the process and product quality will now be also monitored. In implementing these extensive requirements, Optima, as a turnkey provider, also benefited from the interface transparency to and into all functional areas of the line.
The same applies to formal processes: The demands of the pharmaceutical company were significantly higher than anything that had previously been requested. For example, change control procedures, and very detailed qualification documents (discussed more below).
Keck explains why this is remarkable and worth reporting, “As a company, we learned something new in this project. Above all, as a partner to the pharmaceutical industry, we have proven that we always meet the highest technical and formal standards, even when it comes to SCADA systems. At the same time, this project created the foundation for future projects.” The vial system with freeze dryers served, as a “pilot project” in the SCADA area. In the next step, new syringe lines of the customer will benefit from the lessons learned in this project.
The first task of a SCADA system is the continuous safeguarding and documentation of the fill-and-finish processes, including isolator and freeze dryer, in the interest of patient safety. The comprehensive data transparency created here also sets a broad foundation for successful audits. If any (partial) process is questioned even years later, the pharmaceutical company can access data and provide answers quickly.
However, the SCADA system is also extremely important for the pharmaceutical company internally. Structures and automation ensure SCADA-generated data can be accessed at any time, by any authorized employee of the customer – this is especially important for large and complex company organizations because data cannot be manually moved to arbitrary directories.
Data from the SCADA must also be tamper-proof. At large pharmaceutical companies, high-level administrators ensure conformance to procedures and the clearing of deviations between actual and target values. These procedures can, for example, clarify whether the drugs in question meet the quality criteria or what caused the deviations. For administrators to be able to initiate these complex processes at all, it is essential that the underlying data cannot be manipulated. In other words: Trust in employees is good, but automated, tamper-proof control and alarm systems are mandatory. The SCADA system creates data and process transparency synchronously regardless of location. An administrator with the appropriate authorization can view almost every part of
the system, from any location. GMP-critical parameters are the primary focus. Additional data and analysis provide insights in the event of deviations from target values that can be attributed solely to the so-called “business risk” i.e. they will not influence the product safety or quality, but are relevant to the economic efficiency of the processes at the customer company.
To protect the installed SCADA system from external assaults, specific password guidelines were set-up and tested for all functions. In addition, automatic-update servers are now part of the security standard.
The Optima turnkey line consists of a washing machine, sterilization tunnel, filling and closing machine (with capper), two RALUT loading systems for the two star-shaped arranged freeze dryers, and another crimping machine for lyophilizates produced by the freeze dryers. Since a freeze-drying process can take several days, the system must be capable of vial filling and closing at the same time – and this is exactly how this line was designed. Consequently, the SCADA system must record multiple batches independently and in parallel.
Optima’s SCADA system is based on the Siemens PCS7 control system. This comprehensive software is the standard for Optima SCADA projects due to its tamper-proof and automated data storage into directories. This ensures that the customer can execute data queries with batch reports and more from anywhere in the world (with Internet access).
Only raw data from the PLC machine controls transfer into the SCADA system. This data – values from sensor measurements or counts – is fed directly into the SCADA system and into the HMIs simultaneously. Additional networking between the HMIs and the SCADA is unnecessary. The SCADA system focuses on GMP-relevant data used for documentation, the remaining 90% of data is only fed into the HMIs and not into the SCADA, says Keck. For example, upcoming maintenance work or other similar data that would not benefit from additional processing is not input to the SCADA system.
We always meet the highest technical and formal standards, including SCADA systems.
The SCADA system is connected to the customer’s primary MES system via an interface. Depending on the requirements, the raw data from the SCADA is transported unchanged to the MES system like a gateway or “translated” into another data protocol. What is initially implemented is an exclusive transfer of actual values to the company’s production control system.
In the follow-up project, target values will be communicated to the fill-and-finish system allowing the pharmaceutical company to control batches from the primary system with the SCADA system. All Optima systems are equipped with the necessary functionality. The Optima software engineering department will develop a customer-specific solution, to initiate automated processes that are triggered when the system starts or stops.
The basic SCADA installation work was completed at the Optima division in Schwäbisch Hall for the filling and closing line with isolator and in Mornshausen for the freeze dryers. As per Optima standard, batch reports were created during the system’s iFAT. The final SCADA integration took Keck to the customer’s system at the installation site.
From an organizational point of view, this makes sense, says Keck, since the SCADA ultimately must be embedded in the customers IT system on site. Preparing this “blindly” would hardly make sense, adds the SCADA expert. At the same time, the “formal shell” of the project is also adhered to since the final qualification must then focus on the self-contained overall system and not just its individual parts. Keck describes the close, cooperative collaboration with the customer with a wink, “The project manager at the customer could have passed as an Optima employee during this time and I could have passed as a colleague at the customer company.”
Turnkey: With SCADA integration of all system functions, Optima benefits from end-to-end interface transparency.
All parameters and potential process deviations are documented and can be tracked years later.
As mentioned, the general criteria requirements in this project were high – with the emphasis on documentation. The Optima documentation was used for the SAT (performed by Optima) and will also be used by the customer for the system’s qualification. It is easy to imagine that there is a significant difference between technical documentation that is typically created to describe system functionality and a document that a pharmaceutical company intends to use for qualification according to GMP criteria. Optima created documentation that satisfied both purposes in close coordination with the customer.
Another feature was the transparency in the project processes, which was ensured by Optima. One thing is already certain today: The current SCADA project is also a novelty for the customer – such a level of detail has never been implemented in a fill-and-finish project before. Future projects will soon benefit from joint achievements.
