scholarly journals Investigation of the Sterility of Diluent in Prefilled Syringes Used for Vaccine Reconstitution at Department of Defense Recruit Training Sites

2020 ◽  
Vol 185 (9-10) ◽  
pp. e1440-e1446
Author(s):  
Chien-Chung Chao ◽  
Zhiwen Zhang ◽  
Tatyana Belinskaya ◽  
Le Jiang ◽  
Brian J Morrison ◽  
...  

Abstract Introduction Measles, mumps, and rubella (MMR) and varicella (VAR) vaccines are the two vaccines administered in large recruit training sites (RTS) that require a single-use syringe to be prefilled with the diluent (ie water) before vaccine reconstitution. Since there are no preservatives in either MMR or VAR vaccines, it is critical to maintain the diluent sterile to ensure the sterility of the reconstituted vaccine. The Department of Defense/Defense Health Agency has instructions on reconstitution of lyophilized vaccines and guidelines for their storage. Vaccine manufacturers provide instructions on how to properly store the diluent. However, there is no clear guidance or standard operating procedures regarding the best practice for preparation and storage of the syringes prefilled with diluent. Various RTS across all four services have their respective routines to best fit their vaccination requirements. Currently, there are no available data on the sterility status of the diluent prepared using these various routines before they are used to reconstitute vaccines. Materials and Methods We investigated the sterility of the diluent (ie water) in prefilled syringes prepared using routines practiced at various RTS. Diluent was drawn up into single syringes and was kept under various conditions (4 °C or room temperature for overnight up to 24 hours) used by various RTS. At indicated time, diluent was injected into sterile vials and the sterility of the diluent was determined by monitoring the presence/growth of bacteria (including aerobic bacteria, mycoplasma, and an obligate intracellular bacterium, Coxiella burnetii), fungi, and viruses for up to 21 days after inoculation into proper and specific culture media. Both traditional cell culture and molecular assays were used to demonstrate the presence or absence of contamination that may compromise the sterility of the diluent. Results Our results demonstrate that the diluent, after being drawn up to fill the syringe, maintains sterility after storage for overnight up to 24 hours at room temperature or 4 °C with or without recapping the syringes, suggesting that current vaccine reconstitution routines practiced at large military RTS are safe. Conclusions Our results demonstrate that in spite of variations in current practices used in various RTS, the diluent in the prefilled syringe tested from each site maintains its sterility and was determined to be safe for use in military health system-wide vaccine reconstitution.

2007 ◽  
Vol 115 (2) ◽  
pp. 149-158 ◽  
Author(s):  
T ROJASDURAN ◽  
C FENTE ◽  
B VAZQUEZ ◽  
C FRANCO ◽  
A SANZMEDEL ◽  
...  

2017 ◽  
Vol 2017 ◽  
pp. 1-9
Author(s):  
Beatriz Quintero Moreno ◽  
María Araque ◽  
Evelyn Mendoza

Objective. To produce two supplemented agar types in order to store pneumococci for several months at room temperature.Methods. Todd-Hewitt/Hemoglobin/Yeast/Charcoal/Agar (TH-HYC) and Todd-Hewitt/Skim-Milk/Yeast/Charcoal/Agar (TH-SYC) were used to prepare two supplemented agar types. Nineteen pneumococci isolated from patients or asymptomatic carriers displaying diverse serotypes and multilocus sequence types (MLST) were subcultured and stored onto supplemented agar types, in four different tests, at room temperature.Findings. At the end of all tests (4–6 months) all noncontaminated subcultures were viable and maintained all phenotypic characteristics. Survival-time curves revealed a slow decrease of viable CFU over time on agar types, but at the end the number of viable CFU was satisfactory (≥2+ of growth). Decreasing of CFU was significantly higher for clinical versus nasopharyngeal isolates. Subcultures contamination rates were 6.25% and 14.58% after 2 and 6 months of storage, respectively.Conclusion. TH-HYC and TH-SYC agar types allowed the viability of pneumococci with several serotypes, MLST, and genetic profiles, after 6 months of storage at room temperature. We consider that these agar types are a valid alternative to preserve pneumococci over an extended period, especially when methods as cryopreservation or lyophilization are not available, and are useful for transporting strains between laboratories.


2020 ◽  
Author(s):  
Mariana Ferdes ◽  
Rodica Roxana Constantinescu

The chrome shavings waste obtained as a result of the leather finishing process accumulates in a large volume in tanneries and represent a major problem for the environment. This waste are particularly resistant to attack of microorganisms, due to the significant concentration of chromium and are thus difficult to degrade. In this study, chrome shavings were analyzed microbiologically by determining the total number of germs and the number of yeasts and molds on specific culture media. Several bacterial and fungal strains were isolated from the cultures in Petri dishes, after the growth of the colonies. These strains were characterized in terms of the production of proteolytic enzymes, by a method of screening on the media with casein, which allows the determination of proteolytic indices of microorganisms. As a result of the tests performed, five bacterial strains probably belonging to the genus Bacillus and two fungal strains from the genera Penicillium and Cladosporium were selected.


2020 ◽  
Vol 185 (Supplement_3) ◽  
pp. 58-62
Author(s):  
Teresa Roberts

Abstract The transformation of the Military Health System to the Defense Health Agency under the National Defense Authorization Act of 2017 is a change of historical proportion. Change can be seen as hard, yet change is always happening. What is actually hard is providing leadership to accomplish the mission and goals for ourselves and our organizations within constant change. Those of us selected for leadership positions often receive standardized preparation and experiences to help us with this challenge. The hard part, though, is not what we often think it is. Leadership is not hard because of the amount of change or the people we are leading. Leadership is hard because, as we increase our rank and responsibilities, there are more people we need to see as people, having an outward mindset toward them, to have a positive influence and impact. In this article, I share the challenge I experienced with an outward mindset in leading the transition of our military treatment facility under the transformation to Defense Health Agency.


2010 ◽  
Vol 175 (5) ◽  
pp. 298-300 ◽  
Author(s):  
Ellen P. Embrey ◽  
Robert Clerman ◽  
Mark F. Gentilman ◽  
Fred Cecere ◽  
William Klenke

2019 ◽  
Vol 30 (6) ◽  
pp. 627-635 ◽  
Author(s):  
Melannie Alexander ◽  
Kangmin Zhu ◽  
Jennifer Cullen ◽  
Celia Byrne ◽  
Derek Brown ◽  
...  

Reproduction ◽  
2004 ◽  
Vol 127 (2) ◽  
pp. 187-194 ◽  
Author(s):  
Y H Choi ◽  
L B Love ◽  
D D Varner ◽  
K Hinrichs

This study was conducted to evaluate the effect of initial cumulus morphology (expanded or compact) and duration of in vitro maturation (24, 30 or 42 h) on the developmental competence of equine oocytes after intracytoplasmic sperm injection (ICSI). The effect of manipulation temperature (room temperature vs 37 °C) at the time of ICSI and concentration of glucose (0.55 vs 5.5 mM) during embryo culture was also investigated. The nuclear maturation rates of expanded (Ex) oocytes were significantly (P < 0.001) higher than those of compact (Cp) oocytes at all maturation times (61–72 vs 23–25% respectively). Forty-eight hours after ICSI of mature Ex oocytes, the rate of cleavage with normal nuclei was significantly (P < 0.05) higher for oocytes matured for 24 h than for those matured for 30 or 42 h (73 vs 57–59% respectively). For Cp oocytes, the morphologic cleavage rates for oocytes matured for 30 h were significantly higher (P < 0.05) than for those matured for 24 or 42 h (86 vs 55–61% respectively). The overall proportion of embryos having more than four normal nuclei at 48 h culture was significantly higher (P < 0.05) for Cp than for Ex oocytes. Manipulation temperature did not affect development of embryos from Ex or Cp oocytes at 96 h after ICSI. Culture in high-glucose medium significantly increased morphologic cleavage of Cp, but not Ex, oocytes (P < 0.05). Embryos from Cp oocytes had a significantly higher average nucleus number after 96-h culture than did embryos from Ex oocytes. These data indicate that developmental competence differs between Ex and Cp equine oocytes, and is differentially affected by the duration of maturation and by composition of embryo culture media.


2020 ◽  
Vol 42 ◽  
pp. e52965
Author(s):  
Wender Cardoso Silva ◽  
Ilva de Fátima Souza ◽  
Vivian Machado Benassi ◽  
Juan Pedro Bretas Roa ◽  
Paulo Henrique Graziotti ◽  
...  

The present work aimed to evaluate the degradability of the chitosan polymer by soil microorganisms. This evaluation was accomplished using the Most Probable Number (MPN) method by plating in drops so that soil microorganisms capable of degrading the polymeric material could be quantified. Soil samples diluted in three specific culture media for each type of microorganism were plated – bacteria, fungi and actinobacteria – and they were maintained at 28°C for seven days to determine the growth rate of fungi and actinobacteria, and for 48 hours for the development of bacteria. Significant differences in the MPN of actinobacteria relative to the other groups analyzed were observed. Thus, the method used was effective for determining the degradability of the chitosan biopolymer when observing the development of microorganisms subjected to the replacement of the carbon source by the addition of 2% w v-1 of the chitosan biopolymer to the culture medium. The formation of clear regions around the microbial colonies was a strong indicator of biodegradation.


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