No abstract

A system utilizing the polymerase chain reaction (PCR), the BAXTM, was compared and validated against standard selective/enrichment assays to detect the presence of Salmonella spp. in artificially contaminated samples of raw materials and cosmetic/pharmaceutical products. After a 24 h incubation in lactose broth or lactose broth with Tween 20, the inoculated samples were analyzed both by the BAXTM system and by standard enrichment/selective methods. Standard enrichment assays required 5–7 days to confirm the presence and identification of Salmonella typhimurium, while the BAXTM system reduced the detection time to 30 h. The BAXTM system allowed a faster quality control evaluation of those raw materials and cosmetic/pharmaceutical formulations that require Salmonella spp. screening.

A PCR‐based assay using a one step sample preparation was developed and validated against standard methods for the rapid detection of Aspergillus niger contamination in cosmetic/pharmaceutical raw materials and finished products. Artificially contaminated samples were added to Sabouraud Dextrose Broth (SDB) with 10% Tween 20 and 3% Soy Lecithin. Samples were then agitated at 200 revolutions per minute for 24 h at 35C. Prior to the PCR assay, sample preparation consisted of adding 10 μL of the 24 h enrichment broth sample mixture to a lysis buffer containing Tris‐EDTA and 0.4% SDS. DNA extraction was accomplished by boiling for 1 h to release the mycelial DNA. After DNA extraction, a 50 μL aliquot of the lysate was then added to a PCR tube containing the following ingredients: 4 Ready‐To‐Go PCR beads, 2 μL of two fungal primers, and 48 μL of sterile water. The DNA primers encoded for specific sequences of the Aspergillus spp. 18S rRNA gene. A 363 bp DNA fragment was detected in all of the artificially contaminated samples. Standard methods require 6–8 days to complete the isolation and identification of mold contamination. However, the PCR‐based assay was completed within 27–30 h. Rapid detection of mold contamination in cosmetic/pharmaceutical raw materials and finished products can be used to optimize the quality evaluation of a sample to allow the release in 27–30 h.