Environmental monitoring refers to the process of collecting environmental data over time and monitoring for any changes that could be detrimental to the manufacturing or distribution of a product.
From pharmaceuticals to food and transportation, accurate monitoring of environmental conditions is crucial across all regulated industries, as even minor fluctuations in temperature, humidity, and pressure can result in significant financial losses and regulatory violations for companies — and put the safety of consumers at risk.
In this article, we outline a series of tips and best practices for industries where precise environmental variable control is essential, and provide recommendations on how to implement an effective environmental monitoring program for your company.
Why does my business need environmental monitoring?
Proper environmental monitoring ensures stable product quality, reduces unnecessary and costly waste, and, ultimately, improves safety for both employees and consumers.
Implementation of an effective environmental program provides substantial benefits for regulated industries, increasing the likelihood of successfully complying with audits, as well as contributing to increased organizational accuracy and efficiency.
Under government-mandated regulations, U.S. companies involved in regulated industries are required by law to implement environmental monitoring systems in order to safeguard production processes and protect consumers. The inclusion of a robust and effective environmental monitoring program is essential for any company intending to successfully compete under such strict regulations.
Healthcare, Pharmaceuticals, and Medical Devices
Environmental monitoring is an issue of particular importance in healthcare, where stringent quality control directly impacts human health.
Strict temperature and humidity controls are necessary in the production, storage, and handling of vaccines and other pharmaceutical drugs to prevent spoilage and maximize profitability.
Subchapter C of Chapter I of the U.S. Food and Drug Administration (FDA) Code of Federal Regulations (CFR) Title 21, states that “all prescription drugs shall be stored at appropriate temperatures and under appropriate conditions […] Appropriate manual, electromechanical, or electronic temperature and humidity recording equipment, devices, and/or logs shall be utilized to document proper storage of prescription drugs.”
Environmental monitoring also plays a significant role in the medical device industry. This includes products involving sterilization, implants, diagnostic tools, and the maintenance of clean rooms.
Additionally, hospitals are required to implement effective environmental monitoring, both to protect patient health and reduce waste. For example, strict temperature controls are needed in operating rooms in order to minimize the likelihood of infection during surgery. ‘
Food & Beverage
As with pharmaceutical drug manufacturing, industries involved in food production represent another major area where environmental monitoring is mandated by law. Proper monitoring of critical conditions along every step of the food production process prevents the spread of food-borne illness.
Subchapter B of Chapter I of the FDA CFR Title 21 requires that food manufacturers “establish and implement temperature controls…monitor the temperature controls with adequate frequency… [and] verify that temperature controls are consistently implemented.”
The aerospace industry operates under strict regulation in order to protect the safety of workers and the public as well as to ensure quality and reliability. Data provided by the inclusion of an environmental monitoring system can be invaluable in documenting complex production processes to pass governmental audit. Under the AS9100 and ISO 9001 regulations, companies involved in the aerospace industry are required to implement an effective quality management system (QMS).
Finally, environmental monitoring is crucial in manufacturing, where the reliability of large-scale industrial production depends on proven consistency in temperature, humidity, and pressure. It improves product quality and facilitates increased efficiency along every step of the manufacturing process, from production to final assembly.
Of course, these are just some of the industries that need to employ environmental monitoring practices for both quality and safety reasons. Transportation, cold chain logistics, and even colleges and universities all rely on environmental monitoring to ensure proper conditions are met.
How to create a reliable environmental monitoring program for your organization
Best practice #1: Align internally
It is essential to maintain clear organizational goals with regard to the specific monitoring needs of your business. Examples of relevant goals include improved quality control, compliance with regulatory audits, reduction of preventable waste resulting from improper storage, and reduced burden on staff.
A specific project owner should be designated responsible for assembling and managing a team that will conduct ongoing environmental monitoring and quality assurance. Team meetings should be held at regular intervals, both to evaluate progress towards assigned goals, as well as to inform future decision-making.
In addition, the inclusion of a well-defined budget dedicated solely to the successful implementation of an environmental monitoring program can be beneficial. By making environmental monitoring a financial priority, companies have the opportunity to minimize risk over both the short and long-term.
Best practice #2: Use the right environmental monitoring tools
Whether you’re monitoring conditions in a lab, warehouse, refrigerated areas, chambers, or incubators, reliable environmental monitoring can make or break a successful product — and prevent a failed audit.
Data loggers play an especially vital role across all areas of industry in ensuring stable environmental conditions. They are electronic devices designed to record environmental data over time. Wireless data loggers provide increased accessibility in industrial spaces where electrical outlets may not be readily available.
We recommend using an up-to-date data logger in order to guarantee optimal results.
Additionally, replaceable sensors, which reduce the need to send equipment in for calibration, have led to a substantial reduction in downtime for businesses where continuous monitoring is key.
Sensors do lose accuracy over time; thus, proper and regular calibration of sensors is essential to ensure that environmental monitoring instruments are functioning optimally. Dickson produces NIST-certified temperature sensors accredited by the A2LA to ensure accurate calibration.
Finally, a cloud-based, continuous environmental monitoring system streamlines the data collection process, allowing for 24/7 remote access and improved data availability. Highly customizable and simple to use, cloud-based monitoring systems are scalable, with added layers of security compared to traditional chart recorders and data loggers.
In addition, cloud-based systems provide alarm notifications which give businesses an opportunity to remotely monitor environmental conditions and intervene when critical conditions exceed their recommended limits. With effective monitoring, early warning systems, and proper backup plans in place, many problems can be avoided.
Best practice #3: Ensure proper monitoring methodologies are followed
To develop a truly effective environmental monitoring program, companies must properly map their environment(s), calibrate their equipment, and validate that the equipment operates and performs as intended — and mandated. We explore each of these in greater detail, below.
Thermal mapping reveals the locations of both hot spots, cold spots, and relative humidity distribution to inform decisions on the optimal placement of environmentally sensitive products. From large warehouses to individual oven chambers, mapping gives companies an improved understanding of how fluctuations in industrial environmental conditions affect product quality and impact reproducibility in the manufacturing process.
As mentioned earlier, sensors must be calibrated regularly in order to function properly and reliably collect environmental data. Replaceable sensors eliminate the need to send out devices for calibration, preventing losses as a result of downtime. Proper calibration is essential to ensure compliance with regulatory audit.
Validation provides additional documentation for companies to help them achieve regulatory compliance. Many regulated businesses are required to perform validation on various process related items such as equipment, utilities, software, facilities, cleaning, and test methods.
As the validation process is detailed, time consuming, and may require specific expertise, often companies need further assistance with the validation process. This can include drafting and execution of installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) protocols. These documents contain the traceability and data to provide evidence that process related items have been thoroughly tested to meet their intended design and required specifications prior to releasing them to be used in a specific process.
When environmental monitoring goes wrong: the consequences
Lapses in environmental monitoring can have serious — and sometimes fatal — consequences. Below, we explore what happens when proper monitoring of critical conditions fails.
Unwanted environmental changes can negatively impact the potency and efficacy of medications, rendering some drugs ineffective. Insulin, for example, requires continuous and strict temperature control throughout the manufacturing and transportation processes.
Because insulin degrades when exposed to high temperatures, it becomes much less effective in reducing blood sugar for those with diabetes. The same is true for numerous other biologic drugs, including vaccines, many of which need to be stored at specific temperatures in order to avoid spoilage.
The majority of radioactive drugs must be produced, shipped, and delivered within a limited window of time in order to remain effective. Without effective monitoring of environmental conditions, companies risk producing unsafe products, leaving them vulnerable to litigation and revenue loss. In fact, despite stringent cold-chain requirements, the industry still loses over $35 billion each year in waste resulting from poor temperature control.
Back in 2017, Baxter International Inc. voluntarily recalled a shipment of Intralipid 20% IV fat emulsion that was incorrectly stored while in transit.
Because emulsion droplets expand when exposed to subfreezing temperatures, use of the drug as indicated following storage under such conditions had the potential to block pulmonary circulation; thus, improper storage could have led to injury or even death.
The company took almost two months to recall the product, and patients were advised to throw the medication away to avoid risking dangerous side effects.
For businesses involved in the production of food, lapses in temperature control (referred to as ‘time and temperature abuse’) can cause preventable outbreaks of food-borne illness and pose a significant risk to human health. This is especially true in the restaurant industry, where refrigerated food requires strict and continuous temperature monitoring. In 2019, the death of a Colorado woman was later attributed to botulism poisoning after eating frozen potatoes that were improperly thawed and stored in a refrigerator for two weeks.
Strict control over temperature, humidity, pressure and other variables is essential in the aerospace industry, reducing the likelihood of thermal expansion, preventing the absorption of excess moisture, and protecting electronic components from damage. Moreover, environmental monitoring is crucial towards protecting human life. The devastating crash of a Boeing 737 Max airplane in 2018 occurred as a result of a malfunctioning angle-of-attack sensor.
As the above examples clearly illustrate, the importance of environmental monitoring for companies involved in the production of regulated goods and products cannot be overstated. With better monitoring systems in place, it is possible that many of the situations highlighted above could have been mitigated — or even avoided altogether.
A variety of resources are available to help businesses implement or improve their environmental monitoring system in order to successfully withstand a regulatory audit.
Companies seeking information on how to best achieve their environmental monitoring goals should first become familiar with the regulations governing the industry.
Established legislation provides the framework within which to operate to ensure compliance with mandated regulations enforced by the government. A thorough and in-depth review of the FDA CFR is a good place to start for any regulated business. In addition, a large collection of FDA guidance documents is publicly available on its website, including information detailing the relevant regulations and specifying the role of environmental monitoring in the production of food, drugs, and medical devices (to name but a few). For those working with vaccines, the CDC has a vaccine handling toolkit available.
Companies specializing in the development of environmental monitoring products and services are also an important resource, providing a variety of resources and valuable expertise to those organizations wanting to implement an environmental monitoring program or improve their existing one. For more resources designed to help your company with environmental monitoring, you can also check out the Dickson blog.
The bottom line
Environmental monitoring plays an important role across a range of regulated industries, improving product quality and preventing losses in efficacy as a result of unwanted changes in critical conditions. Establishing an effective environmental monitoring program not only gives companies a significant advantage when undergoing audits by regulatory bodies, it ensures the safety of the consumers who use these products in their everyday lives.
Dickson offers a variety of environmental monitoring solutions to help companies meet their specific research, production, and regulatory needs. To learn more about how to implement an effective environmental monitoring program for your company, contact Dickson today.
About the author: Before coming to Dickson, Director of Services Antoine Nguyen spent more than 18 years in quality and validation roles in the pharmaceutical and medical device industries.