In regulated industries, maintaining precise environmental conditions is often a very important part of the research and development, manufacturing, logistics, and storage process. If a certain temperature or humidity or pressure level is not maintained, the integrity, effectiveness, and safety of the product may be compromised. Industries reliant on environmental monitoring include the pharmaceutical, food and beverage, aerospace, precision manufacturing, and medical device industries.
In 2021, environmental monitoring is more important than ever. As monitoring technology improves, companies can refine their environmental monitoring techniques to better achieve their goals and to make better, safer products for their consumers. New technology in monitoring also helps companies save money and improve profit, good for their bottom line.
And the year has begun with environmental monitoring being a worldwide news topic–the pandemic has increased the need for such monitoring in multiple ways. Here we will discuss some key concepts around environmental monitoring in 2021 and what you should know.
Environmental Monitoring in the News
The biggest news story of the twelve months is the global pandemic and as we enter 2021, that story has shifted slightly to the COVID-19 vaccines. The two biggest vaccines that have been widely approved in the U.S. so far are the Pfizer and the Moderna vaccines. As these vaccines roll out, there is a lot of discussion about environmental monitoring these vaccines need.
To maintain their safety and effectiveness, these vaccines must be kept in very precise environmental conditions. The vaccine from Moderna must be handled at temperatures around 20 Celsius (-4 Fahrenheit). The Pfizer vaccine requires even colder temperatures. It must be kept in a deep freeze at around -70 Celsius (-94 Fahrenheit).
These vaccines need to be distributed to hundreds of millions of people in the U.S. alone and the faster, the better. This is an incredible logistical challenge. Additionally, these pharma companies are making vaccine doses as quickly as possible. What neither the public, the companies, or the U.S. government can afford is for viable doses to be ruined by improper environmental monitoring.
This environmental monitoring effort is unprecedented, so companies have to ramp up their capabilities by adding more data loggers and remote cloud-based monitoring systems to their systems. Once this is done, it will be much easier to do environmental monitoring in the future, which is good news for regulated industries.
GxP Is More Important Than Ever
The “G” and “P” in GxP stand for “good practices.” X is a placeholder for whichever aspect of a business you are talking about good practices for. This can include good manufacturing practices (GMP) or good logistics practices (GLP). These good practices play a major role in quality assurance, especially in regulated industries. In 2021, as these industries deal with the ripple effects of the pandemic, GxP will become more important than ever.
GxP is all about establishing traceability, accountability, and data integrity when it comes to products and systems in regulated industries. Establishing these three tenets is key to making sure that all applicable measures are followed throughout the process to help ensure the safety of the public. When GxP is not followed or not done correctly, it can result in fines, shutdowns, lawsuits, or products having to be destroyed.
None of the actions above that come from not following GxP are appealing options but, in 2021, these are even more damaging. Due to the economic slowdown and local restrictions based on the pandemic, many companies are working at a reduced capacity. On the other hand, companies in the healthcare and pharma industries are working double-time these days. All this leads to tighter margins, more stress on everything from employees to the supply chain, and other challenges that can lead to corners being cut and GxP being not followed.
This is the exact opposite of what companies in regulated industries should do in these challenging times. These companies need to double-down on GxP and ensure that the products that do go out are of the highest quality so they meet industry standards and companies can profit from them. Dickson’s guide to GxP has several best practices organizations can follow.
Saving Money with Environmental Monitoring
Technology in the environmental monitoring industry is developing fast and is allowing companies in regulated industries to do a more efficient job keeping products at the right environmental conditions. This is good for many reasons, including for the health and safety of consumers, but it especially helps these companies’ bottom lines.
As discussed above, companies are using data loggers to precisely read conditions and report them to cloud-based remote monitoring systems. This is a huge leap forward from older systems where monitors had to be read in their location by a person, a means that, like many older technologies, was labor-intensive, slow, and inefficient. Using cloud-based systems is efficient, saves labor and labor costs, and saves companies money.
With internet-connected data loggers and cloud-based remote monitoring systems, an individual or a small team can monitor precise conditions in real-time. Such systems also enable those monitoring the area to get a real picture of the entire area, not just a snapshot from the areas closest to the thermostat. This makes it possible to address issues when they arise or fix or replace aspects of the system that aren’t working before running afoul of regulations or losing product.
Environmental monitoring has become a hot topic in 2021. It affects all of our lives in numerous ways though we rarely think about it. Like many aspects of our lives today, the pandemic has changed that. Environmental monitoring is key to the vaccine rollout, and an important piece of GxP which is more important than ever in the pandemic fallout, and it can save companies money, critical to today’s bottom lines.