Microbiological Environmental Monitoring in Pharmaceutical Facility

Objective: This study aims to evaluate the validity of pharmaceutical raw materials obtained from an Egyptian pharmaceutical factory to ensure the accuracy of the examination findings before they are used in the manufacturing process. On the other hand, it also aims to determine the environmental microbial count at the microbiology laboratory and production areas to prevent microbial contamination during production and during microbiological analysis. Methods: Assessment of microbiological quality control according to pharmacopeia as plate method by using TSB media with a concentration of 0.1% tween 80, for passive monitoring using settled plate (TSA) media. Results: the percentage of microbial recovery for lactose monohydrate was 89%,

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“…Microbial count at the microbiology laboratory and production area was under acceptance criteria. These results were similar to 17 .…”

Section: Microbial Count At Microbiology Laboratory As the Settled Platesupporting

confidence: 89%

“…To identify evolving patterns in microbial counts and microflora growth in cleanrooms or regulated environments, environmental testing defines the microbiological tests conducted, information on the physical structure of the room, heating, ventilation, and air conditioning (HVAC) system efficiency was given 17 .…”

Section: Air Monitoringmentioning

confidence: 99%

Determination of microbial recovery for some pharmaceutical raw materials and passive monitoring at production area and microbiology laboratory at Egyptian pharmaceutical company

Mohamed

Azab

Fouda

et al. 2021

Journal of Advanced Pharmacy Research

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“…An old water station comprises a 300 m 3 tank that pumped water to the distribution system that supplies the restaurant, production locker and laboratory locker. Environmental monitoring (EM) samples -during testing under laminar air flow (LAF) unit, water sampling and testing were done according to Ashour et al 2011. All microbiological culture media for microbial processing and chemicals were purchased from OXOID (Basingstoke, Hampshire) and Sigma-Alrich (St. Louis, MO 63103), respectively.…”

Section: Methodsmentioning

confidence: 99%

Determination of the Microbiological Quality of Feed City Water to Pharmaceutical Facility: Distribution Study and Statistical Analysis

Eissa¹

2017

AJS

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Supplying feeding water to pharmaceutical plant is critical both for industrial or human consumption purposes. Assessment of microbiological quality and stability is needed to determine the suitability of income city water for human application and other processing in pharmaceutical manufacturing. In the current study statistical analysis and Shewhart charts were used to determine the degree of compliance of the raw city water to the standard microbiological specifications. Although all sampling points of the distribution system met the acceptance criteria, they showed variable degrees of out-of-control states at chronologically non-identical parts of the control charts. The performance of each monitored compartment could be measured by a bioburden level which might provide indication for the disinfection efficacy. The overall capability of the process (Ppk) for each segment of the distribution system was found in the following descending order: water station (2.30), restaurant (2.25), laboratory locker (2.08) and production locker (1.86). Despite the presence of residual chlorine level, the distribution system showed variable degrees of biological instability. Thus, disinfection of feed water cannot be used as a sole measure for protection of aged distribution network and further investigation is required to improve the system quality and maintenance in demand of delivering microbiologically high quality and safe water.

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“…Bacterial visualization was facilitated using colorless Triphenyltetrazolium Chloride (TTC) dye which is reduced from colorless to red insoluble1,3,5-triphenylformazan (TPF) in viable cells by various dehydrogenasesas indicated by some manufacturers of culture media (BD Difco™, 2016). Cultures purity and identity were confirmed by isolation and identification (Estridge et al, 2000;Ashour et al, 2011). Acceptance criteria of the test results were decided based on what is stated (Clontz, 2008…”

Section: Testing and Techniquementioning

confidence: 99%

Assessment for Sporicidal Activity of Two Types of Peroxygen/Silver-Based Disinfectants: A Comparative Study

Eissa

2016

JPTRM

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Numerous cases have been reported globally showing outbreaks, dissemination of infections and/or spoilage of medicinal products, food and other consumables that affects human life and may lead to death in some cases. One of the most critical measures of microbial contamination that should be taken into consideration is the use of proper disinfectant depending on the type of activities and the work load of the healthcare institution, subjects or media for microbial transfer and the affected population. The current study shows significant difference in sporicidal activity between two types of commercial peroxygen/Silver based disinfectants obtained from same manufacturer and delivered through same distributor at the same time. The peroxygen component in one of the disinfectant products is Hydrogen peroxide while in the other product is Peroxyacetic acid/Hydrogen Peroxide mixture. Preliminary rapid assessment of the disinfectants activity was required using the most resistance microbial form (bacterial spore) as a reference microorganism to challenge the biocidal products. Bacillus pumilus and B. subtilis spores were exposed to both disinfectants at three different concentrations levels covering the range recommended by the manufacturer: 1, 3 and 5% (v/v). The first formula did not exceed 0.5 logarithmic reduction(LR) even after 30 minutes. While the other product achieved more than two folds LR (more than 100 times reduction in microbial population) after ten minutes contact time. Appropriate initial screening of biocidal activity in commercial disinfectants market is critical step that should be performed by the healthcare facilities before practical application. Otherwise, inefficient control on bioburden may lead to devastating consequences on human health. An initial, non-laborious, time-saving and non-expensive screening test using the most resistance microorganisms is encouraged to be performed by healthcare facilities prior to practical application of disinfectant rather than reliance solely on random selection of biocidal agents using informational data without confirmatory experiments.

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Microbiological Environmental Monitoring in Pharmaceutical Facility

Cited by 9 publications

References 19 publications

Determination of microbial recovery for some pharmaceutical raw materials and passive monitoring at production area and microbiology laboratory at Egyptian pharmaceutical company

Determination of microbial recovery for some pharmaceutical raw materials and passive monitoring at production area and microbiology laboratory at Egyptian pharmaceutical company

Determination of the Microbiological Quality of Feed City Water to Pharmaceutical Facility: Distribution Study and Statistical Analysis

Assessment for Sporicidal Activity of Two Types of Peroxygen/Silver-Based Disinfectants: A Comparative Study

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