Microbial diversity in pharmaceutical product recalls and environments
- PMID: 18047177
Microbial diversity in pharmaceutical product recalls and environments
Abstract
Identification of microbial contaminants in product recalls and environmental samples provides important information on the possible contamination sources and distribution of microbial species in pharmaceutical environments. Analysis of FDA product recall data for 134 non-sterile pharmaceutical products from 1998 to September 2006 demonstrated that 48% of recalls were due to contamination by either Burkholderia cepacia, Pseudomonas spp., or Ralstonia picketti, while yeast and mold contamination were found in 23% of recalls. Gram-negative bacteria accounted for 60% of recalls, but only 4% were associated with Gram-positive bacteria. Of the 193 recalls of sterile products, 78% were due to the lack of sterility assurance and 7% for yeast and mold contamination. For sterile products, Gram-negative bacteria accounted for 6% of recalls, with only 1% due to Gram-positive bacteria. For non-sterile and sterile products, B. cepacia was the most frequently isolated microbial species with 22% and 2.5% of recalls, respectively. Based upon the review of the scientific literature, B. cepacia, Pseudomonas spp., or Ralstonia picketti may be associated with water contamination, while yeast and mold and Gram-positive bacteria may have indicated deficient environmental controls. The presence of unculturable microbial populations in pharmaceutical waters and clean rooms was reported, but no evidence has been published that product quality was negatively affected.
Similar articles
-
Quality Control Testing for Tracking Endotoxin-Producing Gram-Negative Bacteria during the Preparation of Polyvalent Snake Antivenom Immunoglobulin.PDA J Pharm Sci Technol. 2015 Jul-Aug;69(4):499-510. doi: 10.5731/pdajpst.2015.01058. PDA J Pharm Sci Technol. 2015. PMID: 26242786
-
Contamination Control.Int J Pharm Compd. 2015 May-Jun;19(3):232-8. Int J Pharm Compd. 2015. PMID: 26714364
-
[Correlation of bacteria in the contaminated drug and the environmental microbes in the clean room for pharmaceutical microbial test investigated by FTIR].Yao Xue Xue Bao. 2007 Nov;42(11):1189-94. Yao Xue Xue Bao. 2007. PMID: 18300477 Chinese.
-
Burkholderia cepacia Complex Bacteria: a Feared Contamination Risk in Water-Based Pharmaceutical Products.Clin Microbiol Rev. 2020 Apr 15;33(3):e00139-19. doi: 10.1128/CMR.00139-19. Print 2020 Jun 17. Clin Microbiol Rev. 2020. PMID: 32295766 Free PMC article. Review.
-
Quality Assurance and Quality Control, Part 2.Int J Pharm Compd. 2015 May-Jun;19(3):215-21. Int J Pharm Compd. 2015. PMID: 26714362 Review.
Cited by
-
Transcriptional response of Burkholderia cenocepacia J2315 sessile cells to treatments with high doses of hydrogen peroxide and sodium hypochlorite.BMC Genomics. 2010 Feb 5;11:90. doi: 10.1186/1471-2164-11-90. BMC Genomics. 2010. PMID: 20137066 Free PMC article.
-
An outbreak of Burkholderia cepacia complex exit site infection among peritoneal dialysis patients caused by contaminated spray dressing.Infect Prev Pract. 2024 Mar 16;6(2):100359. doi: 10.1016/j.infpip.2024.100359. eCollection 2024 Jun. Infect Prev Pract. 2024. PMID: 38559368 Free PMC article.
-
A comprehensive technology strategy for microbial identification and contamination investigation in the sterile drug manufacturing facility-a case study.Front Microbiol. 2024 Feb 12;15:1327175. doi: 10.3389/fmicb.2024.1327175. eCollection 2024. Front Microbiol. 2024. PMID: 38410390 Free PMC article.
-
Specific Detection and Enumeration of Burkholderia cepacia Complex by Flow Cytometry Using a Fluorescence-Labeled Oligonucleotide Probe.Microorganisms. 2022 Jun 7;10(6):1170. doi: 10.3390/microorganisms10061170. Microorganisms. 2022. PMID: 35744688 Free PMC article.
-
Diagnostics method for the rapid quantitative detection and identification of low-level contamination of high-purity water with pathogenic bacteria.J Ind Microbiol Biotechnol. 2013 Sep;40(9):1005-13. doi: 10.1007/s10295-013-1295-1. Epub 2013 Jun 20. J Ind Microbiol Biotechnol. 2013. PMID: 23783648
Publication types
MeSH terms
LinkOut - more resources
Other Literature Sources
Medical
Miscellaneous