For many industries, environmental monitoring is a requirement. For example, pharma and biopharma companies require sterile production environments. Microprocessor manufacturers need to maintain environment purity. Food, beverage, and nutritional supplement producers need to maintain pathogen-free environments.
All of these applications have the challenge of managing a high volume of samples and tests, often in complex scheduling requirements, to maintain their environmental monitoring programs.
What is Environmental Monitoring?
Regardless of application, environmental monitoring involves the same fundamental processes of monitoring of conditions in controlled environments, often across multiple facilities and operations in an enterprise. This monitoring is achieved through a program that includes planning, scheduling, sampling, testing and reporting/trending.
Environmental monitoring programs are challenging to define and manage for the acute need to follow quality standards as well as for the high sample volumes required. Adherence to guidelines must be maintained with evidence at all times. To help with efficiency, those guidelines can be implemented into a program that automates sample scheduling and sample collection plans, and then processes those samples through a lab testing workflow. With laboratory automation, test results can be automatically flagged for suspects and positives for rapid confirmatory testing and additional sampling based on industry protocols. Result trending can identify and anticipate out of control conditions. The programs are designed to maintain the operational monitoring and the evidence that the operation is in a state of compliance.
The added pressure of a potential quality incident or audit creates its own slew of challenges: the urgent need for compliance, the high-stakes risk of the presence of a pathogen, the bandwidth that could be required to execute additional sampling and testing, and the documentation requirements to substantiate claims of compliance.
Industries That Require Environmental Monitoring
Any business that needs to produce a product under sterile or pathogen-free conditions will need high volume environmental monitoring sample and test processing. These operations have a constant need to ensure sterility or cleanliness within their facilities to allow for the safe manufacturing of products. If a contaminant were to come into play, the impact it could have could be very significant; not only could this shut down production but members of the public could get hurt, too.
Industries that require environmental monitoring include:
- Pharmaceuticals: The pharmaceutical industry, including biopharmaceuticals, tend to have the most stringent demands for environmental programs to meet regulatory needs. Strict protocols for sampling and testing and detailed evidence must be maintained for compliance.
- Food and Beverage: This industry requires high sample volumes and has high potential impact if environmental monitoring is not adequately maintained. Environmental monitoring programs must be aligned with variable production lines, equipment changes and production schedules to avoid quality incidents or product recalls.
Regardless of the solution implemented for environmental monitoring, it must be customizable, so that it can be fitted to the particular issue at hand.
Moving Away from Manual Documentation for Environmental Monitoring
Businesses across all industries will often need to report on quarterly trend data for products across all sampling sites and sources. This data must be readily available in the event of an audit, which is always a possibility. If these businesses cannot easily locate or show the data behind their products, they can get cited. Consistent citations can lead to shutdowns.
The use of environmental monitoring within LIMS allows business to scale in size and production. The sampling may be planned and scheduled in advance so that constant monitoring is enforced and lab operations can anticipate the volume of testing that is required of them. In addition, those lab operations must be aligned with the sample flow or the business risks an operation interruption. Each industry and its associated applications have unique definitions for quality and these definitions define the sampling plan for testing. Laboratories must be able to prove that they followed this plan and must support the sample test throughput required to maintain production.
Historically, environmental monitoring has been a manual process. Operations would have to plan sampling programs by protocol, schedule the samplers, have the samplers collect and label samples and deliver to the lab for testing. This entire process would often be recorded by hand on paper or in spreadsheets. Each instance of manual action introduces a high potential for error, which only increases further in the event of high volumes of samples.
Just manually executing an environmental monitoring program with a large volume of samples takes more time and introduces opportunities for profound inconsistencies, even when the associated testing SOPs are attempted with relative success. Manual environmental monitoring programs also reduce lab operation’s visibility to the incoming workload and sets up a potential bottleneck in production.
Consequences of Poor Environmental Monitoring
If environmental monitoring is not executed properly, the results can be expensive, at best, or disastrous, at worst, potentially jeopardizing public safety.
Good environmental monitoring allows for the interception of problems early or before they happen. For example, a positive contamination test allows the laboratory to minimize the window of damage. Otherwise, this contaminant or other detected problem could have far-reaching consequences. For this reason, it is vital for environmental monitoring to be performed regularly and consistently in a defined protocol. Labs will apply data trending to anticipate issues. For example, alerts can be set to include test results (e.g. presumptive positive) and data trends (e.g. 3 points rising).
When an alert occurs, the laboratory will react and take actions such as confirmatory testing and investigation, which can document issues such as:
- Is there an issue with a particular batch?
- Is there a systemic issue?
- Is there a trend that indicates a process going out of control?
These are some of the considerations that must be factored into responding to alerts. Adherence to best practices in environmental monitoring allows for types of frequent testing at various points in the production process so that problems may be accurately characterized and acted upon for the fastest possible resolution with minimal, if any, consequences.
If this testing were to be performed manually or on paper, it would be easier to miss trends and harder to test as frequently or consistently. Without a view of alert trends, some systemic issues may not be spotted until larger batches of product are compromised—and potentially already in the public's hands.
Not implementing top-quality environmental monitoring leaves massive risks for compromising brand reputation and destroying customer trust. It can leave a business or laboratory legally exposed. Regulatory agencies can assess a fine or work stoppage for any non-remediated steps that were documented in audit warning letters. For consumer products, there is potential exposure for civil lawsuits that are high in costs and potentially lethal for a company’s reputation.
Solutions to Meet High Sample Volumes in Environmental Monitoring
Environmental monitoring is challenging for laboratories because of the need to manage a high volume of samples in support of often complex quality requirements. What solutions are available to laboratories to meet these challenges and remain both compliant and operational?
A successful LIMS implementation allows labs in any industry and of any size to be able to implement regular environmental monitoring in ways that gives them the evidence needed for compliance in a future audit. A comprehensive LIMS can help manage environmental monitoring samples as well as samples from other sources, such as QC production, eliminating the complexity of implementing, validating and maintaining multiple LIMS.
The successful implementation of LIMS within the laboratory setting can automate the testing, data collection, and data storage mentioned here, enforcing the sustainability of repeatable processing in a timely manner, and can also flag any issues in real-time as they are occurring—allowing for more rapid intervention in the event of an issue—and no matter how many samples need to be processed.