title: Performance Equivalence and Validation of the Soleris Automated System for Quantitative Microbial Content Testing Using Pure Suspension Cultures.
abstract: Using United States Pharmacopeia-National Formulary (USP-NF) general method <1223> guidance, the Soleris(®) automated system and reagents (Nonfermenting Total Viable Count for bacteria and Direct Yeast and Mold for yeast and mold) were validated, using a performance equivalence approach, as an alternative to plate counting for total microbial content analysis using five representative microbes: Staphylococcus aureus, Bacillus subtilis, Pseudomonas aeruginosa, Candida albicans, and Aspergillus brasiliensis. Detection times (DTs) in the alternative automated system were linearly correlated to CFU/sample (R(2) = 0.94-0.97) with ≥70% accuracy per USP General Chapter <1223> guidance. The LOD and LOQ of the automated system were statistically similar to the traditional plate count method. This system was significantly more precise than plate counting (RSD 1.2-2.9% for DT, 7.8-40.6% for plate counts), was statistically comparable to plate counting with respect to variations in analyst, vial lots, and instruments, and was robust when variations in the operating detection thresholds (dTs; ±2 units) were used. The automated system produced accurate results, was more precise and less labor-intensive, and met or exceeded criteria for a valid alternative quantitative method, consistent with USP-NF general method <1223> guidance.
authors: The Procter & Gamble Co., Global Microbiology Capability Organization, Mason, OH 45040, USA.
authors: Brian J
authors: BJ
authors: Limberg
authors: The Procter & Gamble Co., Global Microbiology Capability Organization, Mason, OH 45040, USA.
authors: Kevin
authors: K
authors: Johnstone
authors: The Procter & Gamble Co., Global Microbiology Capability Organization, Mason, OH 45040, USA.
authors: Thomas
authors: T
authors: Filloon
authors: The Procter & Gamble Co., Global Microbiology Capability Organization, Mason, OH 45040, USA.
authors: Carl
authors: C
authors: Catrenich
mesh_terms: D001230:Aspergillus / Q000302:isolation & purification*; D001331:Automation / Q000592:standards*; D001412:Bacillus subtilis / Q000302:isolation & purification*; D002176:Candida albicans / Q000302:isolation & purification*; D015169:Colony Count, Microbial; D011550:Pseudomonas aeruginosa / Q000302:isolation & purification*; D013211:Staphylococcus aureus / Q000302:isolation & purification*