Environmental Monitoring with a LIMS

Environmental Monitoring - Clean Room

There are two ways to think about environmental monitoring. In environmental science, it involves field work: wastewater sampling, soil sampling, or outdoor air quality testing. The samples go to a lab, are processed, and results are reported back to the submitter.

The other way to think about environmental monitoring is within a lab or clean room setting, where temperature and humidity can affect results, or where lab staff work with nuclear, biological, or chemical substances that could cause physical harm. In these settings, samples are taken by an air sampler at predefined intervals within the rooms, or from people and equipment at defined locations, so that any anomalies can be easily detected for proper remediation. These samples typically go to a microbiology group in a Quality Control department. The COVID-19 pandemic has made many businesses more cognizant of the need for air quality monitoring, and has also increased the prevalence of labs working with infectious disease. These factors increase the need for a laboratory information management system (LIMS) that can handle environmental monitoring.

A typical LIMS is designed for a setting in which production samples are brought to fixed instruments in a lab. Environmental science field work is supported by a LIMS in the same way as any other sampling-based methodology. A simple description of the typical sampling-based LIMS workflow is shown in Figure 1.

Figure 1. Typical LIMS Workflow

With the rising concern for safety in labs and testing accuracy due to the coronavirus, we will focus this blog on clean rooms and sensitive lab settings that require the sample collector and the LIMS to do a bit more work than in normal sample-based workflows. Because these workflows are not a typical out-of-the-box feature of LIMS, they need to be configured separately, presenting barriers to using a LIMS for environmental monitoring, but also providing many benefits.

Barriers to Using LIMS to Support Environmental Monitoring

A LIMS is not specifically designed to support clean room environmental monitoring or other remote location sampling protocols. So, to accommodate different sampling environments, most of the top-tier LIMS vendors provide a Storage Location Management module and a Scheduling module in their LIMS that can be used together to support environmental monitoring. While this is beneficial to the labs, the LIMS will require significant configuration.

Another barrier for the use of a LIMS for clean room environmental monitoring is the restricted nature of sampling locations and the general limitation of sample scheduling in a LIMS. It can be difficult to accommodate non-routine samples and process mistakes. Also, sample logging in a clean room may require a mobile-friendly version of the LIMS that is loaded on a sterile tablet, accompanied by a sterile label printer. Clean room sampling often needs to be assigned among various microbiologists or technicians due to the need for specialized PPE and the prevalence of limited access labs. This, too, is not usually supported by an out-of-the-box LIMS.

Lastly, the physical location of the sample is an essential piece of information for environmental monitoring, but it’s not captured in a typical LIMS workflow. When the Storage Location Management module is added to the LIMS and configured properly, associating a location with the sample becomes possible.

LIMS for Environmental Monitoring in Lab Settings

The barriers to using a traditional LIMS for clean room environmental monitoring can be overcome, and most commercial LIMS providers can accommodate environmental monitoring workflows in some way. The environmental monitoring modules that are available with some LIMS products can be configured to support lab workflows. The LIMS can also be configured to support standard operating procedures (SOPs) and easily produce a complete chain of custody for all the samples. In what follows we will look at the solutions available from several LIMS top-tier LIMS vendors.

Environmental monitoring options with STARLIMS

The STARLIMS Environmental Sciences LIMS is intended primarily for field work settings, and works well for water quality analysis at public water or sewer utilities. The sampling process can be automated when instruments are integrated with the LIMS. This allows for suspect results to be flagged for follow up. The LIMS has industry-specific analytical methods, quality controls, and specifications preconfigured so your lab can get to work quickly.

STARLIMS also has new capabilities for clean room sampling and monitoring that are configurable in the system. Sampling areas can be labeled with barcodes to make sample collection easier. You can also designate locations for sample incubation in the system, and run the samples in batches for easier analysis. To address sampling areas that are not WiFi enabled, the STARLIMS mobile app can also work offline.

Environmental monitoring options with LabVantage

LabVantage has a Sample Monitoring module that must be purchased as a separate line item. It works out of the box, but it does need to be configure to meet the required schedules and add Test Method master data as usual. The module is called Sample Monitoring because it is suitable for many purposes, not just environmental monitoring. Integrating air sampling instrumentation is also possible.

LabVantage recently partnered with Lonza to offer a LIMS interface to the MODA-EM solution. The MODA Connector provides bidirectional flow of testing requests and microbial analysis results between the systems. LIMS users can also see any environmental monitoring issues in the manufacturing process, to ensure lot quality.

LabVantage offers several instrument integration options—Web services come with LabVantage out of the box, and Empower connectivity is a licensed module that has to be configured. Custom imports of data files generated by the instruments or staging table data are available via configurable Excel import or custom coding if there’s more complexity. These options for instrument integration can make certain types of clean room environmental monitoring sample collection easier to do.

Webinar: "Defining Value of Integrating Instruments in LabVantage"

Environmental monitoring options with LabWare

LabWare LIMS has a template that is a combination of their Process Scheduler and Storage Location Manager modules that uses visual workflows as its backbone. It is included with the Pharma Template. This template allows for association of a physical location (building, room, zone, sampling location) with sample types, which, as we mentioned earlier, is a special need for clean room environmental monitoring. Schedules can be programmed for point monitoring and to log samples automatically. Unscheduled, manual sampling can also be accommodated. Not having to configure this functionality is an advantage of LabWare LIMS.

To learn other features LabWare LIMS offers, watch this webinar: LabWare LIMS Can Do THAT?

Making the configuration work for you

With some configuration of the available LIMS modules and templates, you can track locations and associated tests, resulting in a useful environmental monitoring workflow. The required configuration can be complex, and you may want to work with experienced consultants to make sure the result fits your needs.

Make Full Use of Your LIMS for Environmental Monitoring

In addition to the modules and tools provided by the top-tier LIMS vendors, labs can extend their environmental monitoring capabilities through a few additional means. First, you can integrate your LIMS with an LES to store your lab’s standard operating procedures (SOPs) and ensure that they are followed. An integrated LIMS/LES has advantages for environmental monitoring because an LES allows more granular information to be stored, such as whether an instrument has been recently calibrated, and tare weights for sampling containers.

Another way to extend capabilities is to maintain a separate LIMS for the QC lab, to do process control and environmental monitoring. This solution can make sense for large pharmaceutical/biopharmaceutical companies that need to comply with the U.S. Food and Drug Administration’s QbD initiative with raw material testing or to ensure the integrity of their finished product by constant monitoring of particle counts in the air or on surfaces.

Reach out to CSols if you’d like to implement an environmental monitoring solution for your LIMS.

Has the COVID-19 pandemic made you more cognizant of the need for air quality monitoring, not just in the lab but in any workspace?

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Comments

2 responses to “Environmental Monitoring with a LIMS”

  1. Ted says:

    Pharma supply chains will have to enhance their ability to effectively monitor the facilities and staff due to the COVID 19 pandemic and the new reality we will be living in. I agree this can easily be done using, really any decent LIMS system.

    I think this would also apply to many industries as well. Phase 1, 2, and 3 opening of the economy will require enhanced environmental monitoring to reopen facilities around the US and most importantly keep them open.

    The EM Monitoring I am thinking of would consists of:
    Production Areas (Rooms locations – routine, scheduled or random)
    Production monitoring (Lot specific or during production/entry and entry/egress areas)
    Personnel monitoring (People working in the facility, especially production and testing areas or around open product and raw materials)
    Personnel monitoring (People working in the facility, especially production and testing areas or around open product and raw materials)
    Hot Spots like main entrances, doors, frequently used portable equipment and restrooms/gowning.

    The goals of a Post-Covid EM Program would be to:
    To ensure any contamination is detected, so corrective actions can be taken
    Protection of the supply chain against the spread of any contamination
    Protection of facility personnel both internal, external and vendors against contamination

    Thanks TDC

    • Thank you for this comment! This is an excellent point. Another timely use of environmental monitoring capabilities in a LIMS is, as you suggest, to help facilities reopen and remain operational in the face of the COVID-19 pandemic. CSols is currently working with a number of our partners on their COVID-19 responses, and we are well positioned for setting up environmental capabilities for this specific use.

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