Improving and Optimizing Manufacturing Capabilities ​for Freestanding Production Units

• Industry Served: Manufacturing / Medical Devices
• Technology: Closed Loop Process Control / Embedded Programming
• Products & Services: Increase Manufacturability / Ensure Repeatable Product Quality 
• Customer Profile: A small US-based medical product manufacturer that is the global leader in producing pure form HOCl solutions used as antibacterial and antiviral liquid disinfectants. The company manufactures HOCl in an EPA and FDA-registered, GMP-compliant facility in the US and has HOCl production kiosks in multiple countries. ​
• Business Challenge: The company had developed a large HOCl production system that required the skills of an expert chemist to manually monitor production and conduct quality control tests. The manual manufacturing process resulted in inconsistent quality and wasn’t scalable. With surging market demand, the company needed to automate the manufacturing process while maintaining the quality and consistency of their HOCl products.​
• ​Solution: Specialized software expertise was needed to make the existing hardware capable of better controlling the manufacturing process and identifying critical chemical measurement points during production. Automating the monitoring and tracking of chemical measurements enabled a more rapid and cost-effective production process without manual intervention. The automated software improved the production quality of the HOCl, improving the product’s consistency, critical for a medical-grade liquid disinfectant.

• ​Benefits:​
  • An automated process enabled the replication and rapid deployment of pure form HOCl manufacturing to multiple countries to meet market demand
  • Replacing a manual testing process conducted by an experienced chemist improved production scalability and decreased manufacturing costs
    
  • Upgraded embedded software optimized the manufacturing process for improved chemical monitoring, improved the production throughput while maintaining the same quality level

The Challenge

The Company had a proven process for producing HOCl, a liquid medical-grade disinfectant, at consistent high quality. The unique process they developed enables the production of a very stable HOCl with a long shelf-life, in an industry where that capability is rare. 

The process was limited in its scalability because manufacturing needed constant monitoring and adjusting by an experienced chemist during production. Controlling the process involved careful observation of several process variables and constantly performing chemical tests on the output product to keep it within strict tolerance levels. Controlling multiple parameters was key to maintaining the quality of the product, and it is what distinguished the Company’s product above that of its competitors.
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The Company knew the next step in its growth was to automate the process to be able to scale up production of the disinfectant. To add to that challenge, the target time frame to optimize manufacturability had shortened considerably. Demand for the HOCl medical-grade disinfectant was surging with the advent of the COVID-19 pandemic, accelerating the Company’s need to scale production quickly.

The Solution

Replacing the manual intervention by an experienced chemist was key to scaling up production. Automating the process involved using various sensors for measuring the chemistry of the output product and making real-time adjustments to maintain quality output.
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Monitoring the output continuously with an automated process is quite different from sample testing with standard manual techniques. The advantage is that continuous monitoring enables constant adjustment of the system.

S5 Solutions developed an embedded system to provide monitoring and control. The system measures different multiple parameters at the same time. These parameters are then used to calculate adjustments for parts of the fluid-handling system to compensate for any deviations and ensure the product continues to be manufactured to strict specifications.
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The automated manufacturing system uses pumps, valves, and feeders to provide material handling of all the reactants. The output product and waste are also controlled, including the ability to isolate any product that does not meet the quality check, keeping it from being added to the HOCl production tank.

​“They took only a week to do a deep dive assessment and get us on the right track. S5 Solutions is still iterating every design phase and constantly improving performance. They’re really best of class. You couldn’t ask for a better group of people.”
- JW, Director of Product Management, Briotech

Although the automated manufacturing and testing system designed by S5 Solutions makes most chemical adjustments itself, there are some actions that require intervention. The production alert component of the automated system includes the ability to monitor the system remotely and if human intervention is required it sends an alert to an operator who can follow-up with any needed modification. With this remote monitoring capability, it is possible for one central station to keep an eye on multiple production machines, even spread out in different geographic locations.

​The system also performs logging of all the control parameters, so there is a complete record of the production for quality control and for regulatory tracking.​

The Results

The automated control system designed by S5 Solutions achieved the Company’s goal of scaling up production while maintaining quality without constant monitoring by a chemist. Continuous monitoring ensures only the highest quality HOCl product is produced by the system. The resulting automated manufacturing process delivers higher quality, more consistent output than even the most skilled chemist could achieve. This streamlined process also enables higher production throughput of the HOCl liquid disinfectant than was possible previously. Remote monitoring ensures that the product continues to meet all regulatory requirements for quality.
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This replicable process made it possible for the Company to duplicate production in multiple locations to better scale to meet global market demand for their HOCl disinfectant. In combination with a new fully autonomous manufacturing cell designed by S5 Solutions, the Company was able to deploy remotely monitored high-quality HOCl production facilities in numerous countries to meet local needs for medical-grade liquid disinfectants during a worldwide pandemic.