Detection of Burkholderia cepacia in pharmaceutical products

Abstract

Burkholderia cepacia complex (BCC) have recently received a reasonable attention as one of the major risks in susceptible pharmaceutical products. This microorganism can easily spread and cause severe contamination especially to the water stations for pharmaceutical companies. It rapidly grow within the product and cause cystic fibrosis and septicemia in humans. Aim: The traceability of the sources of contamination of pharmaceutical non-sterile aqueous preserved products and how to control it during the manufacturing operations as it is concern with the public health. Materials and Methods: The samples collected for the analysis were taken from different sources provided from the pharmaceutical company such as: aqueous finished products, filling machines, preparation tanks and water stations, identified by API 20NE, Vitek 2 compact system and 16S rRNA. Results: From 213 different samples of finished product, 22 bacterial isolates had been identified as Burkholderia cepacia group. Raw materials and primary packaging materials did not result in any bacterial isolates while the machine surfaces and preparation tanks were contaminated. From 384 pharmaceutical water samples, 35 isolates were identified as B.cepacia. Conclusion:Our study suggests that the chlorine treatment and hydrogen peroxide have a significant effect on B.cepacia in water disinfection.

Patogenesis dan virulensi Burkholderia pseudomallei penyebab melioidosis dan Burkholderia cepacia sebagai patogen oportunis

“…Namun kondisi paling serius yang disebabkan oleh infeksi bakteri ini adalah pneumonia atau infeksi bakteri pada paru khususnya CF. (19) Mikroorganisme ini menyebabkan tiga masalah penting pada kelompok penderita CF, yaitu multi resisten terhadap agen antimikrobia, transmisi antar manusia (secara nosokomial ataupun nonnosokomial) serta menyebabkan sindrom cepacia. (20,21) Sindrom cepacia merupakan pneumonia yang sering diasosiasikan dengan septikemia.…”

A culture-independent nucleic acid diagnostics method for use in the detection and quantification of Burkholderia cepacia complex contamination in aqueous finished pharmaceutical products

“…To date, there have been several peer-reviewed publications describing the development of Nucleic Acid Diagnostic (NAD) methods for detecting and identifying Bcc in FPPs [37][38][39][40][41]. However, these studies have limitations.…”

“…Many required a pre-enrichment growth step prior to using molecular NAD testing methods (such as PCR, qPCR or 16S rRNA gene sequencing) for specific Bcc identification. The use of a pre-enrichment step increases turnaround time to result, removes the ability to perform absolute quantification and also adds significant test costs [40][41][42]. Furthermore, previously described qPCR methods do not incorporate an internal amplification control (IAC).…”