HMI simplifies FDA and USDA compliance reporting

  • November 25, 2014
  • Case Study

By: Julio Delgado, Stock America Stock America manufactures standalone and fully automatic solutions for in-container sterilization and pasteurization systems for the food and pharmaceutical industries.  The company was founded in 1975 by Hermann Rudolf Stock, owner of the German-based Hermann Stock Maschinenfabrik (HSM) and the inventor of the original Stock rotary batch sterilizers. Our initial focus in the 1970’s and early 1980’s was introducing the U.S. market to the technological advantages of end-over-end rotation and full water immersion processing. These two features are inherent in our Rotomat batch retort system. Unlike the simple steam retorts that dominated the U.S. market at the time, these technologies, which had been popular for many decades in Europe and Asia, offered greater flexibility  and dramatic reductions in process times as well as better quality end products. In the 1990s, Stock America continued to grow and expand its U.S. based competencies by investing in its own control engineering capacity and developing its award-winning Icon control system, which received FDA acceptance in 1994. The company also broadened its product line to include energy efficient static and rotary steam spray retort systems. In 2006, STOCK America opened a new assembly and testing facility located in Raleigh, N.C. Today, Stock America offers customers a variety of machines used in the food processing and pharmaceutical industries. These include material handling, pilot systems, and batch and continuous sterilizers. In order to comply with government regulations, each machine’s processes must be FDA and USDA compliant. Food and drug manufacturers are responsible for ensuring the safety of the product as well as maintaining the cleanliness of the plant. Thus they must adhere to strict requirements that regulate the sterilization of the product.

All food and beverage as well as pharmaceutical processing in the U.S. must adhere to FDA 21 CFR Part 11 regulations. These guidelines improve public safety by stipulating the information required for an audit trail of records, such as detailed recipes and all user activity reports during a shift. Although our internally developed control system included operator interface functionality, we wanted to make improvements in that area, so we began a search for an off-the-shelf HMI software package that would meet our requirements. Ease of Development After an extensive evaluation, we selected InduSoft Web Studio over a number of competitors for a variety of reasons as summarized in Table 1 and as explained below. Table 1: HMI Features for Simplifying FDA Compliance

  • Database connectivity
  • Tag structure (classes)
  • User activity logs
  • eSignatures
  • Track and trace capabilities
  • Report generation
  • Remote data access

InduSoft Web Studio streamlines the creation of HMI applications for our Icon Retort Management System provided in our sterilization and retort equipment. Being able to sell compliant machines that provide process verification within the control system is a huge asset to Stock America and its customers. This software package provides all the tools required for creating FDA and USDA compliant applications. Over 240 native drivers are included, making it easy to interface with a wide range of PLCs and other automation equipment such as analyzers. Technology and regulations often change in the food and drug market, so we appreciate the ease of developing our custom HMI and SCADA applications. Using InduSoft Web Studio, we can develop highly flexible applications that are easy to deploy, and that can be understood by plant operators and engineers at a glance (Figure 1).   Figure 1: Operators monitor the retort machines for information on air pressure, the status of circulation pumps, chain conveyers, and heating and cooling.

In addition to creating front-end graphics, we must also create back-end data management structures, a task made easy by Web Studio as its tag structure enables us to use indirect tags, create tag classes (structures) and change tag names on the fly that easily propagate throughout the system. This dramatically decreases development time that otherwise would be spent on creating individual tags for each process variable. Once these tag names are created they become data, which must be recorded and shared. Recording Important Data Reporting is vital to complying with government requirements, so Stock America needs a robust HMI solution for our retort and sterilization machines. Not only does the HMI monitor our machines (Figure 2), it also provides reliable and accurate real-time information and records for each process.   Figure 2: A graphical overview of the water immersion process allows the operator to see alarms, conditions and parameters at a glance. The HMI solution must easily log important data such as recipes, reports of user activity, alarms, and events. Database connectivity is an important factor in selecting an HMI software solution. Since the FDA regulations require extensive data collection and record keeping, the software has to have the ability to easily send reports to an SQL database. Fortunately, InduSoft Web Studio’s patented database connectivity makes this easy by automating much of the process. The database connectivity enables the system to send and retrieve data such as logs, alarms, trends, events, and other important information from SQL and Oracle databases. Moreover, this same feature offers great flexibility by enabling enterprise connectivity to ERP, MES, and SAP systems. Safeguarding Data In order to maintain compliancy with FDA 21 CFR Part 11, our machines must provide careful logging of user activity. The amount of time spent in various steps of the process is an important metric in the food and drug industries and must be carefully monitored and recorded. Fortunately, this capability is included in the HMI software in the form of eSignatures that record all user activity. Individual users are also restricted or allowed access to the system according to security levels. Each user is given a username and password that can be changed to protect security. Operators are restricted based on security level, and all process changes are logged. In order to ensure traceability in activities, the HMI system must record all user actions, as well as provide the ability to distinguish between operators by their username and password combination. Reports are then generated at the end of each batch and sent to an SQL database for reporting purposes. All operator activities must be performed at various locations throughout the plant, so the HMI must be distributed and not just local.   Remote Access As a result of smaller staffing levels in the food and drug industries coupled with flexible production requirements, operators must manage more machines simultaneously, often in different areas of the plant. Fortunately, our HMI package provides superior remote access capabilities in the form of thin clients. The web thin client gives our customers the ability to access their fully visualized HMIs from a PC, a tablet or a smartphone far away from the plant floor. This is a very valuable addition for supervisors and operators working with the retort machines. The mechanisms required for retort machines to ensure food and drug products are sterile can be quite complex. Thus these machines need sophisticated automation software that controls the process parameters critical to the proper sterilization of the products. Both local and remote operators must be informed at all times about the machines’ operation, and thin clients facilitate these activities. The use of the web thin client and the patented database connectivity make it easy to log all the necessary data, and then review or print it from any location. This makes Stock America’s machine data easily portable, and it keeps plant operators and supervisors aware of process alarms and trending information even when they’re not on the plant floor. We’re so pleased with flexibility and ease of use of the HMI package that we’ve selected it for our complete line of machine, enabling us to offer our customers turnkey solutions for their sterilization and retort needs. Our customers are very happy with the intuitive graphic displays that make it easy for their operators to get a quick overview of the system or drill down to a specific area. They’re also pleased the HMI doesn’t require intensive training as the intuitive interfaces make the retort machines very user friendly and versatile in comparison to similar machines on the market.

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