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Challenges of Enviro...

1st July 2020  Content supplied by: Microgenetics

Microbes Aren't Your Only Threat: The Risks of Environmental Monitoring 

In the highly regulated world of Pharmaceutical manufacturing, Environmental Monitoring is essential for patient safety. However, the process is not without risks of its own; in labs using paper and Excel or other legacy systems; even your best efforts can leave your lab open to risk, the consequences of which range from heavy fines to even something as priceless as a patient’s life.

The process
If you are still using legacy systems, your monitoring process may look something like this (figure 1): 


Figure 1: The process of environmental monitoring for labs using paper and Excel or other legacy systems.

If this is the case, each stage presents different challenges. Let’s start at stage 3, where your plates have been moved from your cleanroom to the lab, and your data will be transcribed - often onto a paper record. 

If you are familiar with the ALCOA+ principles of data integrity - that being data should be accurate, legible, contemporaneous, original and accurate, then complete, consistent, enduring, available for the + symbol - then you might have already spotted the issue.

By transcribing onto paper, your record is not original, as it will have to be re-transcribed to your system. Additionally, the record is open to human error, risking inaccurate data, and if your handwriting is poor or rushed, it may not be legible. Paper can also easily be lost or misplaced and isn’t a permanent record. You can see where we are going with this – even at this early stage, the integrity of your data can already be questioned.

Once your data is recorded, your plates will be incubated and then read. When this stage is reached, there are two main risks; firstly, a count risk, especially where growths are small, non-contrasting, or occluded. This is particularly problematic if the count is near a threshold; for example, miscounting a single CFU in a grade A environment could mean a limit breach is missed.

Secondly, limit confusion. An under-pressure person trying to recall the settle plate alert limit for a particular room can make mistakes – especially at the end of a long shift. The good news is that some of this risk can be reduced by second checking, thus catching discrepancies, as well as by photographing plates to give an enduring audit trail. 

When you have counted colonies, you will then need to record the data which carries the same ALCOA+ risks as the first transcription stage, with additional association risks that may occur if the count is recorded against the wrong sample record. This particularly highlights the issues of not using the original record and/or unique identifiers, which would otherwise mean these multiple transcription stages are not required.

Once you have recorded your data, you may then need to carry out an investigation. Investigations should be thorough and ideally identify the root cause of contamination promptly. However, this can be a challenge for legacy labs, who lack easy access to the correct information or the tools to analyse.

As a result, investigations may be delayed or lead to inadequate action, and at its most extreme the underlying event(s) may have passed and conditions changed by the time a conclusion is reached, missing an opportunity to achieve proactive control.

Once you have investigated, your findings will need to be transcribed from your paper records to Excel or a similar system. You might think the most significant danger here is unmotivated staff due to the monotonous nature of data entry, but if you consider the ALCOA+ principles, you will see that at this stage, every principle is broken; for example, data is not attributable to the individual who first recorded it and will not correspond with the date it was first recorded, so is not contemporaneous. Multiple transcription stages decrease the accuracy of data, and on Excel, a true audit trail cannot be created. 

Once you have transcribed your data, you will then analyse the results in the trending stage; this relies on the ability of staff to be able to identify and understand trends and be competent with Excel or the system used. There are also limitations with the tool, for example, to predict future trends - making the lab reactive rather than proactive. If a trend is identified, it can be difficult to dive below the surface to identify contributing risk factors. 

The consequences
When you consider the risks discussed above, you may feel it can be hard to trust the data. But what are the consequences? Internally, QC labs are sometimes seen by the wider business as lacking added value. Limited insight and responsiveness to the business needs due to information not being readily available contributes to this view, resulting in pressure from senior executives to enhance performance.

Many Quality professionals consider economic performance a goal; however, for labs using legacy systems with multiple time-consuming transcription stages, this will prove a difficult goal to achieve.

Externally, consequences may be more severe. With the number of warning letters and statements of non-compliance with GMP citing data integrity alone on the rise, labs face increasing external scrutiny, heavy fines and in some circumstances, temporary suspension of manufacturing licenses or even licence removal.

Ultimately though, the consequences stretch far beyond impact to business; by being unable to identify breaches and react to trends, patient safety is at risk. In extreme circumstances, contamination could result in a patient becoming seriously ill or even death. Minimising errors and risks are, therefore, of utmost importance. 

The solution
Many of these risks can be minimised through the use of environmental monitoring software, which reduce your use of manual data entry, paper and Excel spreadsheets, helping labs to become compliant with GMP and maintain the ALCOA+ principles of data integrity.

One such software solution is Microgenetics SmartControl; using this software, entering a sample takes 5 seconds, and notification of limit breaches is instant, saving time throughout the Environmental Monitoring process which could otherwise be used to second-check plates or innovate.

It also comes equipped with a photobooth - a high-resolution 4k photo capture device with controlled lighting, to ensure good quality of photos of every plate. These photos are stored on the cloud along with the data, making the original records and any subsequent amends easily accessible to multiple users and providing an audit trail.

SmartControl is able to carry out an in-depth analysis of data captured in minutes, allowing labs to understand their results better and identify trends.

In addition, SmartControl also offers machine learning tools, where it can conduct automated in-depth analysis of your data, uncovering previously hidden trends and enabling labs to be pro-active rather than reactive.

To find out more about the risks of environmental monitoring and how to solve them, click the following link now to read Microgenetics’ full whitepaper: microgenetics.co.uk/microbes-threat-whitepaper/



Date Published: 1st July 2020

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