Environmental Monitoring in the Pharmaceutical & Nutraceutical Industries

FDA expects manufacturers to be in control of the environmental conditions within the manufacturing facility. Controlling the environmental condition is not only a regulatory requirement but also part of protecting and producing a quality product. Environmental monitoring of Pharmaceutical & Nutraceutical manufacturing facilities provides assurance that the environment is in control, and in compliance.  There is substantial evidence establishing a direct relationship between the level of environmental control and the final quality of the product.

A variety of methods are available to measure total particles in the air, Total Organic Carbon (TOC), and ATP (Adenosine Tri-phosphate).  These methods while very fast to perform do not correlate with total bacterial count or any specific group of organisms in many cases.  Therefore, these results do not tell us when we have viable organisms in the environment and on production lines. The standard plating methodologies can take several days for results.  Rapid microbiological methods can provide the solution

Why Not Monitor ATP?

Adenosine-Tri-Phosphate (ATP) is an energy molecule stored in all microorganisms and therefore an indicator of life.  ATP bioluminescence began to gain traction over plate count approaches in the late 1980s, especially in the food industry.  It is basically a “dirt” detector rather than a microorganism detector.   It is a common misconception that the results received from ATP testing systems in relative light units (RLUs) for surface samples should correlate with a microbial total plate count result.

The lack of correlation between ATP and plate counts means that samples can have high ATP readings and no bacteria or conversely have low ATP readings and high bacteria count.  For example, the inside of a tomato is sterile and doesn’t contain bacteria, yet it contains large amounts of ATP.  Likewise, it is possible to have bacteria and still get pass from an ATP based test, because 10,000 bacteria/swab are required for detection.  To complicate the matter further, there are different levels of ATP in different cells on the surface. Yeast, for example, contains 100 times the ATP amount of Coliform bacteria.

The standard used for post-cleaning surface contamination is typically 100 – 1,000 bacteria / 100cm2, and 10-50 yeast and molds which is lower than the detection limit for the ATP test.   Therefore, ATP results do not tell whether the surface is microbiologically acceptable.  In other words, it does not tell how many or what kind of microorganisms or chemical contaminants are present on the surface—only that there is organic matter present on the surface in which microorganisms might be able to grow.  Also, sanitizer residues on food contact surfaces or certain food components may interfere with the ATP reaction.

The BioLumix Advantage

BioLumix is an optical rapid, automated system that simplifies microbiological testing.  The system can be utilized for simplified monitoring of the manufacturing environment. Three assays were tested:  Total Aerobic Count, Total Combined Mold and Yeast Count, and Bile Tolerant Gram Negative Count (Enterobacterial Count).  A study was performed to compare and validate the BioLumix system as an alternative to the standard plate count method in detecting microbial contamination in manufacturers’ production surfaces.  Five different surfaces were used to simulate production surfaces.  10X10 cm coupons were inoculated with microorganisms, allowed to dry and then swabbed.  The swabs were inserted into a diluent (buffer or TSB) and analyzed by both the BioLumix and plate count assays.

A total of 550 coupons were tested, 290 were inoculated with various levels of contamination from <10 to <5,000 cfu/swab. The swabs containing microorganisms above the specified levels showed a very good correlation between the BioLumix and the various plate count results, with an overall agreement for samples above spec of 97.2%.  Almost all the discrepant swabs had plate counts very close to the specified level. None of remaining 260 swabs which contained counts below the specified levels did detect in the BioLumix system.  Consequently there was 100% agreement between the two methods.  The system also has the utility to detect for objectionable organisms such as E. coli, S. aureus and Salmonella.

Therefore, the BioLumix system offers:

  •  Automation of results
  •  Speed
  • Paperless
  • Detects microorganisms and not indicators
  • Can detect multiple types of organisms
  • Increases operation efficiency and consequently, improves quality and reduces costs                 
  • Enhanced reporting and ability to track trends

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