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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.

To determine the sterility of pharmaceutical samples, highly conserved bacterial ribosomal DNA sequences were used in a PCR‐based assay. Finished products, raw materials, growth media, and diluents were artificially contaminated with different types of microorganisms. Samples were incubated for 24 h. After incubation, microbial DNA was extracted from enrichment broths using a Tris‐EDTA‐Tween 20 buffer containing proteinase K. Extracted DNA was added to Ready‐To‐Go PCR beads and eubacterial primers. Contaminated samples were found to contain the conserved 1.5 kilobase (kb) DNA fragment of the bacterial genome by using the PCR assay. None of the uninoculated samples was found to show the presence of the 1.5 kb fragment. PCR test results were compared with standard conventional methods. There was a 100% correlation between standard conventional methods and the PCR assay. However, the PCR‐based assay was completed within 27 h while conventional methods required 4–5 days. Rapid PCR analysis using a simple sample preparation reduced the time for sterility testing of pharmaceutical samples allowing optimization of risk assessment and implementation of corrective actions.