Application

Microbial Screening of Raw Materials, In-Process, and Finished Products

Testing for the level of microbial contamination in raw materials, in-process and finished products is necessary in order to monitor product quality. However, traditional agar methods require several days for results, thereby requiring the manufacturer to hold the materials until results are available. This culminates in costly manufacturing delays and storage costs for inventory. A faster, reliable method provides a better solution for confident decision making with minimal risk.

Key Benefits:

• The Micro PRO™ provides objective and reliable pass/fail results.
• The system provides results within 24 hours.
• The Micro PRO™ is fully automated. Up to 42 samples can be loaded at one time and the system automatically performs the reagent additions, mixing, and sample injection.
• The <Micro PRO™ results correlate well with the traditional plating method.
• A broad spectrum of technical and validation support services are also available.

The data below illustrates pass/fail results obtained on the Micro PRO™ system. If the raw material, in-process, or final product is expected to be free of microbial contamination, the sample is suspended in modified Tryptic Soy Broth (TSB) and generally enriched for 18 to 24 hours. If the product has a specification for the level of allowable microbial content, the sample is first diluted, and then suspended in modified TSB and enriched for 18 to 24 hours. Enriched samples are then diluted in 3 mL of buffer in sterile tubes and loaded onto the instrument. The Micro PRO™ automatically provides results every 6 minutes without any technician intervention.

"Pass" result indicates that the sample does not contain microbial contamination.

Box 1 counts/mL	Box2 counts/mL	Result 1	Result 2	Overall Result
34	9	Pass	Pass	Pass

 

"Fail" result indicates that the sample contains microbial contamination.

Box 1 counts/mL	Box2 counts/mL	Result 1	Result 2	Overall Result
1,549,689	19,402	Fail	Fail	Fail

 

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