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6 Ways Rapid Enumeration can Reduce OOS Investigations

Written by Rapid Micro Biosystems | Oct 23, 2013 12:30:00 PM

With slim margins and fierce competition, most pharmaceutical companies simply can't afford to waste time or money on unnecessary out-of-specification (OOS) investigations. Likewise, when contamination does occur, quality control personnel need to be able to isolate and handle the problem quickly – before products are lost or delayed.

However, the current, century-old method for microbial testing is rife with potential errors. Even the most highly trained techs can make mistakes that lead to false positives and costly, wasteful investigations. Here are six ways the automatic enumeration of microcolonies can cut these costs down to size.

1. No More Miscounts

Most manufacturing processes have been mechanized or digitized, but microbiologists are still counting colonies by hand. This reliance on the naked eye inevitably leads to errors, and artificially high colony counts cause costly false positives.

In contrast, rapid enumeration involves digital imaging technology that's far more accurate and reliable. The Growth Direct™ System can detect colonies of as few as 100 cells, and it performs counts every 4 hours. With an automated system, QC personnel can rest assured OOS colony counts are actually indicative of a manufacturing problem – not just human error.

2. Fewer Misplaced Plates

When handled by humans, sample plates can easily be misplaced or mislabeled before incubation. Interim counts, with all their necessary handling, compound the potential for error. In an automatic system, every sample can be barcoded and synced to a laboratory information system (LIMS), ensuring that each colony count applies to the right cassette. Automation can also handle the movements from one incubator to the next, further reducing human involvement.

3. Automatic Data Entry

Whether the results are recorded on paper or entered manually into a LIMS, improper data entry can distort even accurate colony counts. Fortunately, automatic counting enables the routine filing and compiling of results. The barcodes attached to each sample allow the system to instantly upload the counts, which QC workers can use to reliably identify trends.

4. Timely Alerts

Fast, automatic data entry also allows for immediate alerts. Technology can be programmed with alert/action limits, and QC personnel can receive emails or text messages as soon as OOS colony counts appear. Ultimately, these fast alerts help techs and managers to react to contamination events.

5. Rapid Results

Because of the limits of the human eye, it can take up to 14 days before colonies grow large enough for manual counting. The Growth Direct™ System's imaging technology, on the other hand, can detect microcolonies in about half the time of the traditional test. With faster results, QC workers are more likely to identify and isolate problems for investigation.

6. Targeted Investigations

Automated sample management and digital imaging create a combination of reliability, accuracy and speed. With investigations that uncover data entry or incubation errors nearly eliminated, quality personnel can perform more targeted investigations on identified problem areas.

To learn more about how automatic enumeration can improve your processes, download the free guide, "4 Benefits of Automated Rapid Detection & Enumeration".