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Pharmaceutical

InduSoft Web Studio has played a major role in the Pharmaceutical industry in everything from food and drug packaging and storage, to pharmaceutical manufacturing that must adhere to strict guidelines, such as the FDA 21 CFR Part 11 and EU Annex 11 standards. InduSoft Web Studio has passed major audits from top pharmaceutical companies, and can provide the tools to create a compliance-ready SCADA software solution for the pharmaceutical industry.

Pharmaceutical

GAMP, FDA 21 CFR Part 11, and EU Annex 11 Compliance

InduSoft Web Studio has all the tools required to make a project that adheres to FDA 21 CFR Part 11, EU Annex 11 and GAMP (Good Automated Manufacturing Practice) guidelines. Functionality such as security, e-signatures and traceability, batch reporting and automatic writing to any SQL database are some of the tools that can be employed to maintain a fully compliant process that will meet international standards for food and drug and pharmaceutical manufacturing. The ability to store and record data for each batch makes it easy for representatives of the FDA and EU Annex to audit and verify data.

InduSoft Web Studio Database Connectivity

InduSoft holds a patent on the ability to connect to any SQL database from embedded Windows operating systems. InduSoft Web Studio has powerful database connectivity features, making it easy to meet the stringent logging requirements necessary in the pharmaceutical industry. Databases can be easily configured for redundancy and store-and-forward configurations ensuring that critical data requirements are met.

Built-in Recipe Functionality

Facilitate easy product changeover with the built-in recipe functionality of the InduSoft Web Studio SCADA software platform. Virtually eliminate human error by enabling the necessary checks using barcode scanning, 2D matrix and RFID data collection. Integrate seamlessly with vision systems to ensure the right product is in its appropriate packaging.

Proper Warehousing Conditions Easy to Monitor

With a full SCADA solution developed on the InduSoft Web Studio platform, it’s easy to monitor and verify warehouse conditions such as air quality, temperature, and humidity. Provide accurate data for storage conditions by utilizing InduSoft’s ability to connect to virtually any device, from temperature controllers to HVAC and filtration systems.

Hardware Independent

Run InduSoft Web Studio on any Windows PC, including the NEMA 4x, IP65 and stainless steel mounted PCs that provide a sterile and safe surface in pharmaceutical manufacturing. For more information on the types of panel PCs available with InduSoft Web Studio’s SCADA software already installed, please see our list of certified hardware manufacturers.

From individual machine or material handling HMI to large scale supervisory stations InduSoft Web Studio SCADA HMI software offers everything required for a powerful solution.

IWS tools for FDA 21 CFR Part 11


Pharmaceutical Case Studies

Published on Thursday, May 7, 2015

Automating Temperatures to meet Rigorous Food Safety Standards in Texas




Figure 1: The 55,000 square foot storage facility has multiple temperature zones and must meet strict SQF2000 requirements.


Safe Quality Food (SQF) is an international standard for food safety that employs rigorous standards for controlling and monitoring the safety and quality of food products. To achieve Safe Quality Food (SQF) Level 2 Certification, a Hazardous Analysis and Critical Control Points (HACCP) food safety plan designed by the Global Food Safety Initiative (GFSI) must be implemented, and manufacturers must routinely pass scheduled and unscheduled audits while demonstrating improvement of strict food management safety protocols.

Additional requirements of the program include standards for reporting and record keeping, which dictate how records must be stored, who has access to them, and how they’re retrieved. Safe Quality Food manufacturers must be able to present historical data for food manufacturing operations during the event of an audit or recall.

Hill Country Bakery in Texas teamed up with InduSoft Web Studio Certified System Integrator Patti Engineering to develop a system that would allow them to meet the challenges of maintaining a prestigious Safe Quality Food (SQF2000) Level 2 certification.



Figure 2: Historical data enables facility managers to ensure that all temperature zones stay within acceptable ranges.

The Challenge

Refrigeration is a critical aspect of the operations at Hill Country Bakery.  Finished and raw baked goods and ingredients must be maintained at precise temperatures to ensure both the quality and safety of the product. With a 55,000 square foot cold storage facility and multiple temperature zones, the task of developing a temperature control system proved complex.

To meet SQF standards, Hill Country Bakery initially employed hard-wired temperature sensors to collect data, which then had to be stored and recorded manually. As the operation grew, the bakery quickly realized that the errors inherent in manual reporting might prevent them from easily meeting the Level 2 Certification requirements. In addition, the physical placement of the wired temperature probes became a hazard for forklifts and operators who would occasionally bump them out of place and disrupt data collection.

These inefficiencies prompted Hill Country Bakery to contact Patti Engineering, a CSIA and InduSoft Web Studio certified system integrator. The bakery requested an automated temperature monitoring system that would withstand the requirements of the physical environment and offer reliable automated record keeping and real-time monitoring for the various temperature zones of the cold storage facility. As the project progressed, they also asked Patti Engineering to implement remote monitoring and alarm notification that could be accessed on smartphones and mobile devices.

 


Figure 3: The system offers real-time data for each temperature zone and can be accessed on the PC or via mobile devices.


The Results

The first step Patti Engineering took was to install wireless temperature sensors to prevent the problem of exposed wiring and sensors that could be easily dislodged or disrupted. Patti Engineering chose InduSoft Web Studio to act as the HMI for this project, due to the availability of hundreds of hardware drivers and the flexibility of the software to create HMI/SCADA applications that can be easily upgraded as new requirements are introduced.

Patti Engineering developed a customized HMI solution using InduSoft Web Studio that offered Hill Country Bakery everything they needed to monitor the temperature zones, collect the data, create reports, and meet SQF requirements.  The new system offers real-time monitoring of all temperature zones that can be viewed from the SCADA system installed in the facility manager’s office, or on mobile devices that use a secure username and password system to display data. The system also automatically sends email notifications of alarms for temperature shifts, or any issue which might compromise the safety of the ingredients stored within the facility.

 Figure 4: The wireless sensors are placed in hard-to-reach locations where they will not be disrupted by forklifts or facility employees.


The InduSoft Web Studio HMI communicates directly to the gateway of the temperature probes via ModbusTCP, which offers the system a direct link to the data and saved Patti Engineering and Hill Country Bakery substantial costs for additional PLC hardware and development time.

Temperature logging no longer occurs manually, which has also saved Hill Country Bakery costs in labor. The automated logging and easy report generation also improve data integrity and dramatically reduce time spent in the auditing process for continued SQF Level 2 certification. Operators can respond more quickly to problems thanks to alarms delivered directly to smartphones, and the ability to rapidly address potential issues means that less product is wasted when temperatures fluctuate outside acceptable levels.

 

 

Figure 5: Data can be retrieved quickly in the form of reports that make auditing and recalls much easier than before.

The Future

The success of the system designed for Hill Country Bakery by Patti Engineering, and the flexibility of InduSoft Web Studio mean that the system can easily be updated as requirements expand, hardware changes, or the system becomes more integrated with other aspects of the facility controls. In the future, Hill Country Bakery has plans to expand the system to include control and adjustment of temperature settings. An ambitious plan for the future may potentially include data collection and monitoring for manufacturing lines, along with OEE (Overall Equipment Effectiveness) tools to improve the efficiency of the production lines within the bakery.


Figure 6: Maintaining stable temperatures is critical to food safety, and products must be traceable even after they have shipped.



For more information contact your local distributor or InduSoft directly at info@indusoft.com or 877-INDUSOFT (877-463-8763877-463-8763) or 512-349-0334512-349-0334.


© 2015 Schneider Electric Software, LLC. All rights reserved. All other products or services are trademarks of their respective companies.

 

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