Microbiological standards for air and raw materials

Russell, M.

doi:10.1016/0265-3036(88)90003-6

Cited by 2 publications

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“…Control of microbiological contamination of the raw materials is extremely important, because microorganisms may contaminate the Wnished product as well as the manufacturing plant, which cause an intermittent or continuous pollution of the product that is very diYcult to eliminate [33]. The microorganisms that appear in the raw materials can be the origin of certain diseases or may cause spoilage of the medicaments.…”

Section: Introductionmentioning

confidence: 99%

Detection of indicator pathogens from pharmaceutical finished products and raw materials using multiplex PCR and comparison with conventional microbiological methods

Karanam

Reddy

Raju

et al. 2008

J Ind Microbiol Biotechnol

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A multiplex PCR assay was devised and compared with standard conventional methods for quality evaluation of pharmaceutical raw materials and finished products with low levels of microbial contamination. Samples which were artificially contaminated with <10 colony forming units of Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa, and Salmonella species and possibly contaminated samples were incubated for 16 h with different enrichment media. Primers that deduce 559 bp fragment of the 16S rRNA gene was employed in amplifying E. coli species, similarly invasion protein gene with 275 bp fragment size was used as target for detecting Salmonella spp., in case of S. aureus a 461 bp amplicon from m-RNA nuclease gene, and an 709 bp fragment from oprL gene was used for amplifying P. aeruginosa. The detection limits for artificially contaminants by multiplex PCR was 1 CFU/g, where as in case of conventional method the detection limit was >2 CFU/g. Similarly, when tested with possibly contaminated samples, 35% were detected for E. coli, Salmonella spp., S. aureus and P. aeruginosa species with multiplex PCR, while only 21% were detected with standard conventional microbial methods. Multiplex PCR assay provides sensitive and reliable results and allows for the cost-effective detection of all four bacterial pathogens in single reaction tube.

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Section: Introductionmentioning

confidence: 99%

Detection of indicator pathogens from pharmaceutical finished products and raw materials using multiplex PCR and comparison with conventional microbiological methods

Karanam

Reddy

Raju

et al. 2008

J Ind Microbiol Biotechnol

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“…The microbiological purity of cosmetics is a factor that affects both their shelf life and safety in use. The microbiological content of the raw materials is thus extremely important, because microorganisms may contaminate finished products as well as the manufacturing plant, where they can cause intermittent or continuous product contamination that is very difficult to eliminate [2]. In addition to the microbial content, microbiological analysis generally determines the safety of a product through the absence of indicator microorganisms that can be considered a hazard to consumers and indicative of contamination.…”

Section: Introductionmentioning

confidence: 99%

Molecular detection of bacteria in calcium carbonate powder used in cosmetic formulations

Maiuta

Schwarzentruber

2011

International Journal of Cosmetic Science

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Given that a variety of bacterial species may occur in the calcium carbonate powder used for cosmetic formulations, an understanding of their diversity and abundance is necessary to accurately assess the contamination of the finished product. 16S rRNA was PCR-amplified from genomic DNA extracted from three different calcium carbonate powder grades, and these amplicon libraries were sequenced using deep amplicon sequencing technology. The resulting libraries contained 4149-6688 16S rRNA reads per sample with a length of 327-342 bp. Classification into genus of pyrosequencing reads of the dominant bacterial species found in calcium carbonate powders was used to confirm the absence of Staphylococcus aureus, Pseudomonas aeruginosa, Salmonella spp. and Escherichia coli. The analysis described here can be used to determine the microbial diversity of calcium carbonate powder or the presence of any 'indicator microorganisms' in raw materials as well as in cosmetic products. This work provides guidance for prioritizing subsequent culturable and quantitative analysis, ensuring that potentially significant microorganisms are not left out of risk estimations.

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Microbiological standards for air and raw materials

Cited by 2 publications

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Detection of indicator pathogens from pharmaceutical finished products and raw materials using multiplex PCR and comparison with conventional microbiological methods

Detection of indicator pathogens from pharmaceutical finished products and raw materials using multiplex PCR and comparison with conventional microbiological methods

Molecular detection of bacteria in calcium carbonate powder used in cosmetic formulations

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