A Review of Cleanroom Microflora: Types, Trends, and Patterns

@article{Sandle2011ARO,
  title={A Review of Cleanroom Microflora: Types, Trends, and Patterns},
  author={Tim Sandle},
  journal={PDA Journal of Pharmaceutical Science and Technology},
  year={2011},
  volume={65},
  pages={392 - 403}
}
  • Tim Sandle
  • Published 1 July 2011
  • Medicine
  • PDA Journal of Pharmaceutical Science and Technology
Cleanroom microflora are of importance for microbiologists and quality control personnel in order to assess changes in trends. Shifts in the types of microflora may indicate deviations from the “norm” such as resistant strains or problems with cleaning practices. Given the few published studies of the typical microflora, this paper uniquely reviews over 9000 microbial isolates from a range of different grades of cleanroom. The paper concludes that the typical flora are primarily those… 

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References

SHOWING 1-10 OF 42 REFERENCES

Characterization of predominant bacteria isolates from clean rooms in a pharmaceutical production unit

Bacteria widely distributed in clean rooms are mainly a group of Gram positive strains, showing high resistance to selected disinfectants, and will aid in finding a more effective disinfection method.

Microbial Identification in the Pharmaceutica :I Industry

The authors believe that treatment of alternative microbial identification systems warrants a guidance chapter separate from the proposed General Chapter (1 227) Validation of Alternative Microbiological Methods.

Comparative levels and types of microbial contamination detected in industrial clean rooms.

It was concluded that the stainless-steel strip method for detecting microbial accumulation on surfaces is efficient and sensitive in ultra-clean environments and is the most reliable and practical method for monitoring microbial contamination in future class 100 clean rooms to be used for the assembly of spacecraft which will be sterilized.

Oligophilic Bacteria as Tools To Monitor Aseptic Pharmaceutical Production Units

Oligophile counts in clean rooms in the authors' studies exceeded the standard plate counts and responded to disinfection routines in ways similar to the responses of conventional bacteria.

Source of bacterial shedding in laminar flow theatres.

Comparison of Phenotypic and Genotypic Techniques for Identification of Unusual Aerobic Pathogenic Gram-Negative Bacilli

Data show that MicroSeq provides rapid, unambiguous identification of clinical bacterial isolates, and the improved turnaround time provided by genotypic identification systems may translate into improved clinical outcomes.

Recent findings on the viable but nonculturable state in pathogenic bacteria.

  • J. Oliver
  • Biology
    FEMS microbiology reviews
  • 2010
The central role of catalase in the VBNC response of some bacteria, including its genetic regulation, is described and a variety of interesting chemical and biological factors have been shown to allow resuscitation, including extracellular resuscitation-promoting proteins, a novel quorum-sensing system and interactions with amoeba.

The Role of 16S rRNA Gene Sequencing in Identification of Microorganisms Misidentified by Conventional Methods

It is concluded that the initial identifications of three bacterial blood isolates from three different College of American Pathologists-certified laboratories were erroneous, may have misled clinicians, and potentially impacted patient care.

Comparison of Genotypic and Phenotypic Methods for Species-Level Identification of Clinical Isolates of Coagulase-Negative Staphylococci

The results show that tuf gene sequencing is the best method for identification of CONS, but the API Staph ID test is a reasonably reliable phenotypic alternative, and a drawback of sequence-based genotypic methods may be a lack of quality of deposited sequences in data banks.

Viability and activity in readily culturable bacteria: a review and discussion of the practical issues

It is argued that failure to differentiate clearly between use of the terms ‘viability’ and ‘culturability” in an operational versus a conceptual sense is fuelling the current debate, and an alternative operational terminology is suggested that replaces ‘VBNC’ with expressions that are internally consistent.