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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 Wednesday, February 26, 2014

Automated Batch Process Analysis for the Food and Beverage Industry

Advanced Automation brings customized batch process analysis to the food industry, with better data integrity and the ability to easily meet food safety standards.


  • Advanced Automation develops Batch Process Analysis systems for the food and beverage industry, which aid in meeting food safety standards for the BRC and SQF, as well as passing audits.

  • InduSoft Web Studio was chosen for development of this system because of its open platform, large library of drivers, and flexibility for customization.

  • Customers see complete ROI within 6-12 months of adding the system, and save hundreds of hours in labor costs. Data integrity is improved, and product waste minimized. One-click reports make audits and mock recalls much easier.

Figure 1: Shown here is an eight tank silo for the Batch Process Analysis system, which enables simultaneous batching and production.


 

Background

Few industries are regulated as closely as the food and beverage industry. Food safety standards are particularly critical to public health, and there are many regulating bodies that audit and dictate the standards that food manufacturers must meet. Among these regulatory bodies are the FDA (Food and Drug Administration in the United States), and independent organizations such as the GFSI (Global Food Safety Initiative). Manufacturers of food products are often audited by these agencies for food safety, and as a result, recordkeeping for food manufacturers is vital to the process of food manufacturing and packaging.
 
Mandates are driving the food industry to adopt new safety standards, such as the BRC (British Retail Consortium) and SQF (Safe Quality Food). To meet these standards, food production systems often require improved systems for properly meeting the regulations of these standards, which require frequent audits and mock recalls.
 
Advanced Automation is a provider of the systems that enable food and beverage manufacturers to meet safety standards, preserve the integrity of their data, and streamline the production process. When a customer has needs that cannot be met with off-the-shelf solutions, Advanced Automation works to create custom-built machinery for the food and beverage industry.


Figure 2: View of the “Administrator” main screen.


The Challenge

The need arose for a specialized solution when Advanced Automation was approached by a customer who was undergoing a BRC audit, and having a difficult time properly accounting for ingredient handling, as well as identifying ingredients and batches for a mock recall. Mock recalls can be incredibly difficult if the data is not stored and recorded properly.
 
Manual recording was a particular source of trouble during ingredient handling and mock recalls, particularly for the employee responsible for the batching process. It was very easy to lose data integrity at many points during the process, as ingredients were moved, weighed, transported, and added. With no way to receive an alert if ingredients were missing, added out of order, or improperly weighed, consistency of the product and waste were also an issue. Another large factor in the decision to automate the batch process was the amount of overtime hours accrued as employees spent excessive amounts of time logging data by hand.

With these issues in mind, Advanced Automation began searching for a software that would allow them to work on current and future Batch Process Analysis applications. Key factors in the software decision included the ability to make changes to the application easily, and integrate it both with older hardware already owned by the customer, and newer devices installed by Advanced Automation. Another potential future requirement was the ability to have custom drivers created. An open platform, an extensive PLC driver library, communication with SQL databases, and scripting capabilities were all considered.

InduSoft Web Studio fit the bill for this project. After downloading the trial version of the software, Marcelo Tise, president of Advanced Automation, visited InduSoft Headquarters in Austin, TX, and said, “InduSoft seemed like a great company to work with, and we felt very confident going forward with the project after seeing what InduSoft Web Studio was capable of.”


Figure 3: The system can store an unlimited number of recipes in an SQL database, allowing batching employees to quickly adjust quantities of ingredients based on different recipes.


The Solution

Advanced Automation has created many customized solutions to aid food manufacturers in better meeting safety standards and automating the collection of data. One solution is their Micro Batch Process Analysis solution, which consists of a smart scale and an InduSoft Web Studio Thin Client running on the machine, and another is the Batch Process Analysis system, which can automate an entire silo with multiple tanks.

Advanced Automation designed a smart scale system to solve a wide variety of problems. Recipes are stored in the SQL database, rather than in an employee notebook, and the customer can keep an unlimited number of recipes on the system. Storing the recipes makes it possible to quickly and easily adjust the size of the batch, rather than relying on the batching employee to manually calculate different batch sizes based on the recipe. The smart scale also allows simultaneous recording and production. By weighing each ingredient, the application can record mass balance, lot numbers, tracking information, and current ingredients in stock and in use. The system also allows employees to quickly locate ingredients in the warehouse or in the finished product by lot number, enabling seamless recalls should the need arise.

One-touch reporting is a large component of this application when it comes to audits. By adding a button to download reports, auditing professionals can see a paper trail immediately, or track a lot within seconds. The system can also inform employees how much ingredient is in use, how much is left over, and aids in purchasing and manufacturing decisions.

 

The Results

Advanced Automation’s Batch Process Analysis system offers ROI within 6-12 months, thanks to the savings in overhead and payroll hours. Customers can meet food safety standards quickly and easily, and are able to move through the auditing process much faster than before. Data is more reliable, thanks to the automated recording functions, and can be more easily shared between one stage of the process and the next.

Thanks to the ease of customizing InduSoft Web Studio, Advanced Automation has been able to rapidly develop custom applications for customers in a variety of industries, including baking, adult beverages, fragrances, cheese processing. The large driver library and the ability to develop new drivers means that it’s very easy to add the Batch Process Analysis system to the systems customers already have in place, which allows them to protect their own investments into equipment.

As food safety standards increase and become more consistent globally, working with a flexible, open platform like InduSoft Web Studio will truly make the difference for food and beverage systems.



Figure 4: Before installation of the system, batch ingredients were recorded manually. With the automated system, the smart scale records information by lot number, making it possible to track ingredients anywhere in the warehouse, determine how much is on hand, how much has been used, or what ingredients are currently being used in production.


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


©2014 InduSoft, Inc. The InduSoft logo is a registered trademark of InduSoft, Inc. All other products or services are trademarks of their respective companies.

 

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Matrix Technologies, Inc. Colorado Visit Website Automation or Industrial Control|Automotive|Chemical or Petrochemical|Food and Beverage|Manufacturing|Metals and Mining|Oil and Gas|Packaging|Pharmaceutical|Power and Energy Mangement|Water and Wastewater Details
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