ABSTRACT
RESUMEN La contaminación con microorganismos objetables en los productos farmacéuticos no estériles puede tener el potencial de disminuir o inactivar la actividad farmacológica y terapéutica del principio activo y por ende representar un peligro de gran riesgo para la salud de la persona que está en tratamiento con fármacos; adicionalmente la presencia de estos microorganismos dependiendo de su capacidad para producir enfermedad en huéspedes susceptibles pueden ocasionar infecciones no esperadas o enfermedades que afecten al paciente o consumidor de estos medicamentos no estériles. El objetivo del trabajo fue desarrollar un análisis de riesgo microbiológico de microorganismos objetables en un suplemento dietario de una industria farmacéutica como herramienta en la gestión de seguridad. La metodología fue observacional-descriptivo de corte transverso. En la industria farmacéutica (en el suplemento dietario) se desarrolló un análisis de riesgo estudiando todos los parámetros, teniendo como resultado, que las cápsulas blandas con aceite de Krill, no presentan microorganismo objetable del tipo patógeno, como producto de bajo riesgo, por lo que es aprobado para la liberación del lote siguiendo estos parámetros. En Paraguay no existen normativas acerca del análisis de microorganismos objetables, en comparación con otros países como Argentina, y desde hace tiempo en EE. UU y países europeos (por reportes de la FDA) por lo cual, este trabajo es relevante y de vital importancia para establecer legislaciones nacionales con miras a la fabricación de medicamentos seguros, confiables y eficaces.
ABSTRACT Contamination with objectionable microorganisms in non sterile pharmaceutical products may have the potential to decrease or inactivate the pharmacological and therapeutic activity of the active principle and therefore represent a danger of great risk to the health of the person who is being treated with drugs, additionally, the presence of these microorganisms, depending on their ability to produce disease in susceptible hosts, can cause unexpected infections or diseases that affect the patient or consumer of these non sterile drugs. The objective of the work was to develop a microbiological risk analysis of objectionable microorganisms in a dietary supplement of a pharmaceutical industry as a tool in safety management. This was an observational-descriptive cross-sectional study. In the pharmaceutical industry (in the dietary supplement) a risk analysis was developed studying all the parameters, having as a result that the soft capsules with Krill oil do not present objectionable microorganisms of the pathogenic type, as a low risk product, therefore it is approved for batch release following these parameters. In Paraguay there are no regulations about the analysis of objectionable microorganisms, in comparison with other countries such as Argentina, and for a long time in the US and European countries (due to FDA reports). Therefore, this work is relevant and very vital important to establish national legislation with a view of the manufacture of safe, reliable and effective drugs.
ABSTRACT
A substantial majority of global population owns cellular phones independently to demographic factors like age, economic status, and educational attainment. In this study, we investigated the diversity of microorganisms associated with cellular phones of 27 individuals using cultivation-based methods. Cellular phones were sampled using cotton swabs and a total of 554 isolates representing different morphotypes were obtained on four growth media. Matrix-assisted laser desorption ionization time of flight (MALDI-TOF) mass spectrometry could generate protein profiles for 527 isolates and species-level identification was obtained for 415 isolates. A dendrogram was constructed based on the protein profiles of the remaining isolates, to group 112 isolates under 39 different proteotypes. The representative strains of each group were selected for 16S rRNA gene and ITS region sequencing based identification. Staphylococcus, Bacillus, Micrococcus, and Pseudomonas were the most frequently encountered bacteria, and Candida, Aspergillus, Aureobasidium, and Cryptococcus were in case of fungi. At species-level the prevalence of Micrococcus luteus, Staphylococcus hominis, Staphylococcus epidermidis, Staphylococcus arlettae, Bacillus subtilis, and Candida parapsilosis was observed, most of these species are commensal microorganisms of human skin. UPGMA dendrogram and PCoA biplot generated based on the microbial communities associated with all cellular phones exhibited build-up of specific communities on cellular phones and the prevalence of objectionable microorganisms in some of the cellular phones can be attributed to the poor hygiene and sanitary practices. The study also revealed the impact of MALDI-TOF MS spectral quality on the identification results. Overall MALDI-TOF appears a powerful tool for routine microbial identification and de-replication of microorganisms. Quality filtering of MALDI-TOF MS spectrum, development of better sample processing methods and enriching the spectral database will improve the role of MALDI-TOF MS in microbial identifications.
