RT Journal Article
SR Electronic
T1 Application of Fourier-Transform Infrared Spectroscopy (FT-IR) for Staphylococcus Epidermidis Typing as a Tool for Contamination Control Strategy in a Pharmaceutical Industry Facility
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 761
OP 762
DO 10.5731/pdajpst.2024.99906
VO 78
IS 6
A1 Loreiro, J.M.P.
A1 Guimarães, r.C.C.
A1 Valadao, t.B.
A1 Miranda, r.V.S.L.
A1 Andrade, j.M.
A1 Costa, l.V.
A1 Brandao, M.L.L.
YR 2024
UL http://journal.pda.org/content/78/6/761.abstract
AB The typing of micro-organisms in pharmaceutical factories often relies on expensive and time-consuming molecular techniques. So, the implementation of cheap, fast and reliable typing methods in the routine would speed up the investigation procedures improving the contamination control strategy. The Fourier-transform infrared (FT-IR) spectroscopy is a method that generates spectra, that enables to micro-organisms typing within 3 h. This study aimed to evaluate the FT-IR for typing S. epidermidis strains isolated from an immunobiological pharmaceutical industry in Brazil. Fifty strains were evaluated by FT-IR using IR Biotyper®. A dendrogram was created with the raw data to cluster the separation spectrum and the cut-off value was automatically calculated. Forty-four FT-IR profiles were obtained, a ratio of 1.14 strain/profile. From the five clusters formed, Cluster 1, 2 and 3 (6 strains) were isolated from environmental monitoring of air and operators (EMO). Cluster 4 (3 strains) were isolated from EMO and bioburden assays, suggesting that the environment could be the main source of bacterial contamination in the product analyzed in bioburden assay. Cluster 5 (2 strains) were isolated from EMO and a cell culture lineage used in quality control assays, suggesting that the environment could also be the main source of cell contamination.