Comparison between different automated methodologies for the identification of gram-positive rods isolated from clean rooms

Abstract

Introduction: One of the major risks associated with drugs and immunobiologicals production is microbial contamination. Therefore, an environmental monitoring program is essential to ensure that aseptic production areas are maintained under appropriate control levels. To be efficient, it must contain an adequate identification level of isolated microorganisms, because the information provided may be extremely relevant in investigating sources of contamination of products or processes. Sporulated Gram-positive rods (SGPR) are among the main contaminant groups of productive clean areas from Bio-Manguinhos in 2016 and 2017. Due to spore resistance, SGPR’s are not easily eliminated. SGPR identification by classical methods is particularly difficult because of similarities between closely related species that share the same morphological and biochemical patterns. The pharmaceutical industry has adopted automated identification systems, due to greater rigidity in regulatory requirements, regarding microbial identification. However, many identification systems have databases directed to medical microorganisms, being more limited considering pharmaceutical and industrial environmental microorganisms, which makes it difficult to obtain results at species level.