One of the trends that has emerged from the COVID-19 pandemic is the onshoring of U.S. pharmaceutical manufacturing. As more companies focus on manufacturing in the U.S., they face stringent requirements from the U.S. Food and Drug Administration (FDA) to meet cleanroom compliance, such as monitoring the particles in the air.
To help pharmaceutical manufacturers with cleanroom compliance, Phizzle has introduced the EDGMaker digital air series, which is the first internet of things (IoT) solution to operate multi-vendor particle counters remotely.
The Growth of Onshoring and Meeting FDA Compliance Standards
The COVID-19 pandemic has forced companies to recognize the dangers of offshoring all of their pharmaceutical manufacturing during a crisis. Onshoring, the opposite of offshoring, focuses on relocating processes back inside national borders to reduce the risks associated with outsourcing, such as supply shortages, disruptions in supply chains, work interruptions, and importing problems.
As more companies focus on manufacturing pharmaceuticals like COVID-19 vaccines and other drugs in the U.S., the growth of onshoring brings its own challenges. Critically, companies must comply with stringent FDA requirements. In particular, their cleanrooms, isolated environments for manufacturing, must be free from pollutants or contaminants to be FDA compliant.
The FDA requires cleanrooms to be strictly controlled, including monitoring airborne particles, air pressure, airflow, temperature, humidity, and lighting. Every cleanroom must have an accurate monitoring system, and most have to be cleaned every 15 minutes. Cleanroom particle counters help measure the air quality, but their maintenance is labor-intensive and requires an average of two technicians per particle counter machine.
In addition to meeting FDA requirements, pharmaceutical manufacturers are feeling the pressure to make products faster, cheaper, and more efficiently. One company, Phizzle, is taking advantage of these trends and offering a solution that can help.
Getting an Automation Boost From IoT
Pharmaceutical manufacturers often work with a variety of machines and vendors in their cleanrooms, so gathering data from different systems can be a challenge. The potential for errors while collecting data from multiple systems is also high. This increases the risk of incurring fines from the FDA that can range from $10 million to $100 million for violating quality standards.
Not following FDA guidelines can be a costly mistake for pharmaceutical manufacturers. For example, one company received a $100 million fine from the FDA for violations of federal quality standards in its facilities. Violations included not following quality-assurance regulations for production, process validation, and process control. The FDA also added that failure to meet the scheduled deadlines to correct the violations would cost the company an extra $15,000 a day per violation with a maximum of $10 million.
Phizzle’s EDGMaker digital air series helps solve many of these challenges for pharmaceutical manufacturers while reducing their risk of incurring FDA fines. It is an edge-based solution, which means it takes full advantage of IoT edge computing. This means data can be processed by a device instead of being transmitted to the cloud or data center.
EDGMaker simplifies cleanroom compliance by remotely operating multi-vendor particle counters that measure air quality. EDGMaker can operate a variety of particle counters from different vendors simultaneously from a single user interface (UI). Using EDGMaker helps manufacturers save money and time by lowering labor costs.
“We’ve digitized the entire process and implemented electronic signature management. The result of using this type of software should reduce labor up to 45%,” says CEO of Phizzle, Ben Davis.
EDGMaker eliminates the need to manually operate particle counters and removes the requirement for laboratory techs to enter the cleanroom constantly to work on the machines, which lowers the risk of contamination. It also increases the accuracy of the data collected from the particle counters by producing standardized data from a variety of devices that create a unified reporting model.
EDGMaker offers automated compliance reporting through digital signatures and integration with lab information management [LIM] systems. This lowers a company’s risk of facing fines from the FDA for violating regulations.
Phizzle’s solution creates the potential for manufacturers to save millions of dollars. Additionally, EDGMaker can be used by a variety of companies in different sectors, such as synthetic biology, pharmaceuticals, and biomanufacturing. The ability to bring edge computing to the cleanroom creates new possibilities for using automation and the internet of things.
Thank you to Lana Bandoim for additional research and reporting in this article. I’m the founder of SynBioBeta, and some of the companies that I write about are sponsors of the SynBioBeta conference and weekly digest.
Article originally published on Forbes: https://www.forbes.com/sites/johncumbers/2021/02/23/pharmaceutical-manufacturing-just-got-an-automation-boost-from-iot/0