Answering your questions about Environmental Monitoring (I)

How much time does it usually take to prepare quarterly or yearly reports? I feel like it takes more time to collect and clean up the data than to actually create the reports.

Once you have set up your trend monitoring program, assuming you have a Standard Operating Procedure (SOP) that defines the terms we talked about today, like what an adverse trend is and your trending frequency, all this should be clear and in place at your facility. It shouldn’t take more than a couple of days. The system should automatically produce the data, and this data should be reviewed and approved on the spot. So, relying on the data should be as easy as clicking to export it and maybe doing a bit of organizing, basically getting your thoughts in order about how to layout the content in the report or how to escalate something for further investigation. If it’s taking you weeks, then something is not set up right to allow for the timely preparation of reports, which is very important.

If you are spending time cleaning data, that’s a concern. There’s a saying, “garbage in, garbage out.” If you’re cleaning data, it means you didn’t set up your lab management system or software correctly, and you might need to review that. If you’re just organizing data and thinking about how to report it, that’s something you can adjust and improve in your trend monitoring program. But you should be following your SOP, which needs to be well structured. So, at this point, it’s really about executing what’s been planned, no matter the frequency.

How do you trend for Grade A areas when the results show less than one colony-forming unit (CFU) over three or six months? Especially, how do we trend having low or no CFU recovery over an extended period?

When you consistently get results showing no CFUs, it’s essential to trend all data together to look for any slight increases in recovery, even at low levels, for particles. Continuous zero CFU results over many years suggest it’s time to review your cleanroom controls and sampling sites. While cleanrooms, especially isolators, are designed to minimize contamination, it’s unrealistic to expect zero contamination indefinitely.

If you consistently see no contamination, it’s worth questioning your sampling methods and site selection. For instance, in your annual report, you might note that there’s been no contamination detected all year and propose adding more sampling locations to identify potential unnoticed contamination sources.

It’s also beneficial to consider other variables that could impact your environment, such as changes in personnel, products, and general cleanroom operations. Taking a broader look at all factors—including interventions like material introduction, waste removal, and the effectiveness of your disinfection and residual removal practices—can provide insights. Ensuring you’re neutralizing disinfectants correctly and considering validation plans are also critical steps.

In short, taking a comprehensive and critical approach to how you trend and assess your cleanroom’s performance, beyond just looking at CFU counts, can reveal more about its true state and potential areas for improvement.

Do you write a separate report for each facility or clean room, or do you compile one annual report that includes data from multiple or all the facilities within a company?

It really depends on what you mean by “facility.” If your physical location includes, for example, two separate facilities each dedicated to a different product or each with its own air handling system, you might need two reports. However, if you have two facilities at the same location, with similar operations and handling the same product, even if one is isolated and the other is a traditional line, it’s worth considering combining their data for comparison.

Your approach should be based on how your facility is structured and how you define “facilities.” Ideally, where possible, combining the data into one report is recommended to avoid having to manage and compare separate lengthy reports. This decision is also strategic, considering various regulatory aspects, such as whether you want an inspector to view both facilities simultaneously. So, there are many factors to consider in determining the best reporting strategy.

Given that most of our samples show zero CFU, how do we define limits, especially since this seems to be within the same context?

The limits for different classified areas are predetermined, especially for Grade A areas where action levels are clearly defined. If you consistently find zero CFUs, this might be a concern, particularly for Grade B, C, and D areas, where you would expect to recover some level of contamination.

Continuous zero CFU results might indicate that your monitoring isn’t capturing the true dynamic conditions of your environment. This could be due to a variety of factors, including how shipments are handled, the use of air samplers and particle counters, and your incubation strategies.

In spaces like Grade C and D, where human and material movements are more frequent, not recovering any CFUs at all might suggest a need to reevaluate your approach. This includes examining your site selection for sample collection, ensuring that you’re sampling an adequate volume (ideally the full cubic meter), and reassessing the methods and equipment used for recovering samples.

Consistently getting zero CFUs across all classified areas could be a red flag, suggesting that your environmental monitoring might not be reflecting the actual conditions or that there’s a gap in your sampling strategy.

Using paper and Excel for trending, how compliant are we in terms of regulatory standards?

It’s entirely possible to manage data entry and Excel spreadsheets in a way that meets compliance standards, reminiscent of practices from two or three decades ago. However, this method demands rigorous manual data controls, including pre-approved forms and robust data integrity measures. All data must be double-checked, and Excel spreadsheets need to be validated and locked, with each data entry reviewed by Quality Assurance (QA) before releasing any trend reports. While compliant, this approach is notably labor-intensive.

Despite the possibility of compliance, relying heavily on manual data entry and Excel is not the most efficient use of labor, especially with current technologies that streamline these processes. The primary concern with Excel and manual entry is not just about the potential for compliance but the inefficient allocation of labor towards tasks that could be automated or simplified through more sophisticated software. These technological solutions allow staff to focus on more critical tasks like site selection and improving detection methods.

Excel spreadsheets, often underestimated, should be treated as formal applications since the records they generate are considered electronic records and must comply with regulatory standards like FDA’s 21 CFR Part 11. This compliance includes stringent requirements for access control, password protection, version control, and secure storage—elements that are vital for ensuring data integrity but are often overlooked with spreadsheet use.

Investing in specialized software not only streamlines the compliance process but also enhances it, making the initial investment worthwhile. This technology should be regarded as essential, just like any other critical equipment in microbiological testing. The shift towards such systems can save considerable time and enhance overall compliance, offering a smarter way to handle data trending tasks.

Is there any advantage in comparing environmental and personnel monitoring to see if spikes in environmental contamination could be linked to specific personnel?

Absolutely, there’s significant value in broadening the analysis to include various factors such as particulates, viable organisms, and sources of contamination like personnel, materials, or waste. This comprehensive approach helps to fully understand the control state of the cleanroom. Focusing solely on environmental factors gives an incomplete picture; incorporating data on personnel and other factors is essential for a holistic view.

The majority of environmental contaminations can be traced back to human sources. Sampling from personnel, especially their garments, directly relates to their activities or interventions in the cleanroom. However, establishing a clear link between personnel actions and contamination events requires precise timing and intervention records, which can be challenging to maintain accurately.

While it’s logical to investigate personnel as potential contamination sources, especially in areas with significant human activity, directly attributing environmental contamination to specific individuals or actions can be difficult. Such correlations are often tentative and should be approached with caution to avoid wrongly attributing blame.

In more controlled environments like Grade A spaces, if you can accurately record the timing of specific interventions, then making a direct correlation might be possible and valuable. However, in areas like Grade B, where there is more movement and activity, it’s understood that personnel are a primary source of contamination.

The possibility of linking environmental contamination to specific personnel actions exists, but it’s challenging and should be pursued carefully to avoid unjustly blaming individuals. It’s particularly relevant in critical process areas and investigations to determine if contamination is personnel-related, as excluding personnel as a source can be crucial for identifying the true cause.

For a startup lab and cleanroom, what software would you recommend specifically for data trending?

In the realm of environmental monitoring (EM) software solutions, there are numerous options available, each with its own set of features and capabilities. A notable example is SherpaPharma, which excels not only in analytics but also in reporting capabilities. With systems like SherpaPharma, accessing and generating data becomes almost instantaneous, enabling users to easily filter and organize data for analysis and reporting. This makes SherpaPharma an efficient, sophisticated, yet straightforward tool for EM trending among the many options available.

Regardless of the specific software chosen, the key to successful data trending is ensuring that the software is properly set up. A well-organized system that allows for clean data input is essential for effective trending and analysis. Therefore, selecting a software solution involves balancing cost against features and ensuring that the chosen system can support your lab’s specific requirements efficiently.