Related Experiment Video
Updated: Jul 9, 2026
09:30
Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies
Published on: March 17, 2023
Microbial diversity in pharmaceutical product recalls and environments
1papomicro@earthlink.net
PDA Journal of Pharmaceutical Science and Technology
|December 1, 2007
Summary
Microbial contamination, especially Gram-negative bacteria like Burkholderia cepacia, frequently causes pharmaceutical product recalls. Addressing water contamination and environmental controls is crucial for preventing microbial contamination in sterile and non-sterile drugs.
Area of Science:
- Pharmaceutical Microbiology
- Environmental Monitoring
- Quality Control
Background:
- Microbial contamination in pharmaceutical products poses a significant risk.
- Understanding contamination sources is vital for preventing product recalls.
Purpose of the Study:
- To analyze the microbial contaminants identified in FDA product recalls.
- To identify common microbial species and their potential sources in pharmaceutical environments.
Main Methods:
- Analysis of FDA product recall data (1998-2006) for sterile and non-sterile pharmaceutical products.
- Review of scientific literature on microbial contamination in pharmaceutical settings.
Main Results:
- 48% of non-sterile recalls were due to Burkholderia cepacia, Pseudomonas spp., or Ralstonia picketti; 23% due to yeast and mold.
- Gram-negative bacteria caused 60% of non-sterile recalls, while Gram-positive bacteria accounted for 4%.
- Burkholderia cepacia was the most frequent isolate in both non-sterile (22%) and sterile (2.5%) recalls.
Conclusions:
- Gram-negative bacteria, particularly B. cepacia, are major contaminants in pharmaceutical recalls.
- Water contamination may be linked to B. cepacia, Pseudomonas spp., and R. picketti.
- Yeast, mold, and Gram-positive bacteria suggest environmental control deficiencies.
Related Concept Videos
01:29Microorganisms in Medicine and Therapeutics
Microorganisms play a fundamental role in vaccine development, gene therapy, and therapeutic production. Their biological properties are harnessed to advance medicine and public health. Beyond immunization, microorganisms contribute to gut health, antibiotic synthesis, and genetic disease treatment.Live Attenuated and Inactivated VaccinesLive attenuated vaccines, such as the measles, mumps, and rubella (MMR) vaccine, utilize weakened forms of pathogens to closely resemble natural infections.
01:25Microbes in Beverage Production
Alcoholic beverages such as wine, beer, and spirits are the products of microbial fermentation processes that transform simple sugars into ethanol and a wide array of complex flavor compounds. These transformations rely on the metabolic activities of specific yeasts and bacteria, which are selected and controlled to yield the desired beverage characteristics.Wine Fermentation and MaturationWine production begins with the crushing of grapes to release juice and pulp, forming a must that is...
01:24iChip
The cultivation of environmental microorganisms has long been hindered by the inability to replicate complex native conditions in vitro. The isolation chip (iChip) addresses this limitation by facilitating the growth of previously uncultivable microorganisms through in situ incubation. Designed for high-throughput microbial cultivation, the iChip comprises hundreds of microchambers, each capable of housing a single microbial cell. These microchambers are loaded with a mixture of molten agar and...
01:22Microenvironments
Microorganisms inhabit highly localized spaces known as microenvironments, which are defined by distinct physical and chemical characteristics. These include oxygen concentration, pH, temperature, light availability, and nutrient levels. The conditions within a microenvironment can differ markedly from those in the surrounding area and significantly influence microbial growth, metabolism, and community structure.Microenvironments often display sharp physicochemical gradients over small spatial...
01:25Rapid Identification of Pathogens
MALDI-TOF MS has transformed clinical microbiology by offering a rapid and reliable method for pathogen identification. The traditional approach to microbial identification typically involves time-consuming culture techniques and biochemical tests, which can delay the initiation of appropriate antimicrobial therapy. MALDI-TOF MS avoids these delays by using characteristic ribosomal protein mass patterns of microbial cells, enabling accurate species-level identification within minutes.Principle...
01:19Pharmacovigilance
Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...