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

  title={A Review of Cleanroom Microflora: Types, Trends, and Patterns},
  author={Tim Sandle},
  journal={PDA Journal of Pharmaceutical Science and Technology},
  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… 

Figures and Tables from this paper

A review of melanized (black) fungal contamination in pharmaceutical products—incidence, drug recall and control measures

From the review of recent pharmaceutical product recalls, fungal contamination is either increasingly common within cleanroom environments or the accuracy of sampling and the level of reporting has risen, and control measures in relation to bioburden and cleanrooms are considered.

Monitoring of Pharmaceutical-Grade Cleanrooms Comparison of Different Fungal Agar for the Environmental

In relation to a growth in reported incidents of fungal contamination of pharmaceutical products, there has been a developing interest by U.S. and U.K. regulators concerning the risk of fungi. This

Comparison of Different Fungal Agar for the Environmental Monitoring of Pharmaceutical-Grade Cleanrooms

The study showed that Sabouraud dextrose agar was the optimal agar for the environmental monitoring of pharmaceutical-grade cleanrooms, and indicated that fungi are not distributed evenly across cleanrooms and that the prevalence of fungi partly relates to the room design and operation.

The environmental monitoring in hospital pharmacy cleanroom and microbiota catalogue preparation

  • M. TršanK. SemeS. Srčič
  • Biology
    Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society
  • 2019

A global disinfectant standard for cleanrooms: Presenting a harmonised approach

  • Tim Sandle
  • Business
  • 2021
Disinfectant efficacy testing is an essential part of a facility contamination control strategy. Pharmaceutical and healthcare products facilities must know that the products they are using can

Why it’s time to strengthen and widen the microbial test panel

The testing of culture media, and conducting microbiological method suitability studies, disinfectant efficacy studies, Antimicrobial Effectiveness Test (or Preservative Efficacy Test) and associated activities, requires the use of a test panel of microorganisms, but the recommended panels have not kept pace with improvements with the authors' understanding of the types of micro organisms likely to cause contamination.

In vitro fungicidal activity of biocides against pharmaceutical environmental fungal isolates

This study clearly demonstrates that the most frequently isolated micro-organisms from an environmental monitoring programme may be periodically subjected to broth microdilution testing with cleanroom disinfectant agents used in the disinfection programme confirm their sensitivity profile.

Adaptation Response Mechanisms of Staphylococcus epidermidis Strains Exposed to Increasing Concentrations of Didecyldimethylammonium Chloride.

In this first report of adaptation of S. epidermidis strains to DDAC, the fatty acid profiling showed that the majority of strains had reduced ratio of saturated to unsaturated fatty acids and decreased content of straight-chain fatty acids, at the expense of the anteiso-branched fatty acids.

An investigation and examination of the levels and types of bacterial contamination on the surface of clean room operators' garments.

The contamination of sterile pharmaceutical products is a serious event which has in the worst case scenario led to patient death. Operators are the primary source of clean room contamination, with

Environmental and Personnel Monitoring Programs—A Risk-Based Case Study of Cutibacterium acnes

A case-study assessment of Cutibacterium acnes is provided in the context of parenteral manufacture for the purpose of assisting in the deciding the necessary controls and the potential monitoring addressing this microbial risk.



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.