scholarly journals Ways to Reduce the Level of Contamination at the Stages of Tableted Chemical Cholera Vaccine Production

Author(s):  
A. Yu. Ul’yanov ◽  
O. D. Klokova ◽  
O. V. Gromova ◽  
V. R. Vol’nikov ◽  
O. A. Volokh ◽  
...  

Objective of the study was an assessment of the degree of contamination of cholera chemical vaccine at the stages of preparation and determination of the ways to reduce it.Materials and methods. Liquid and lyophilized components of the cholera chemical vaccine used in the study: cholerogen-anatoxin and O-antigens of Vibrio cholerae 569B and V. cholerae M-41 strains, as well as auxiliary substances (sucrose, talc, calcium stearate, starch). Granulation was carried out in a device that works on a fluidized bed principle, GPCG 2 (GLATT, Germany). Subsequent tabletizing of the mixture was performed using MiniTabT compression machine (LUXNER, Germany). Studies were conducted on the evaluation of “microbiological purity” at the stages of manufacturing of the cholera chemical vaccine, tablets coated with an enteric coating. Positive or negative growth of microorganisms on Petri dishes with nutrient media was determined on visual inspection.Results and conclusions. The dynamics of changes in microbial contamination at certain technological stages of vaccine production has been revealed. It is shown that the solutions of antigens in the process of separation are subject to microbial contamination which is associated with the use of ammonium sulfate during precipitation and non-sterile water at the stage of dialysis. Sterility of semi-finished products has been achieved through twophase filtration of choleragen-anatoxin and sterilization of O-antigens of V. cholerae 569B and V. cholerae M-41 strains with flowing steam at (100±1) °C for 30 minutes. In order to decrease microbial contamination at the stage of granulation additional fine filters were installed in the air-supply system. Further on comparative assessment of microbial purity of vaccine batches obtained using both, direct compression and preliminary granulation, was carried out. It has been experimentally demonstrated that granulation of the components of a tablet mixture of cholera vaccine leads to a decrease in the level of bacterial contamination and improves the microbiological purity of the finished dosage form.

1992 ◽  
Vol 8 (5) ◽  
pp. 195-197
Author(s):  
Teresa J. Hudson ◽  
Ellen M. Ambroziak ◽  
Rebecca M.R. Coley

Objective: To test for potential bacterial contamination of the ADD-Vantage system when the components are assembled in various hospital environments. Study Design: One hundred fifty ADD-Vantage units were assembled by three different people in three separate locations within a hospital. Each person assembled ten units per day; the study spanned five days. After 72 hours of incubation, units were inspected for evidence of contamination. Setting: ADD-Vantage units were assembled by a pharmacist in a laminar-flow hood, a pharmacy student using the pharmacy counter, and a nurse at a patient's bedside table. Personnel at each site wore their regular work attire. Each person observed handwashing techniques normally used during routine working hours. Data Extraction: Positive results were sent to the hospital microbiology laboratory for determination of growth type. Results: After 72 hours, none of the systems exhibited microbial growth on visual inspection. No differences in microbial contamination of the ADD-Vantage systems relative to assembly site, day of assembly, or person performing the assembly were observed. The incidence of contamination was calculated at less than seven percent. Conclusions: There is minimal risk of bacterial contamination when ADD-Vantage systems are compounded either on a pharmacy counter or at a patient's bedside. Larger samples must be studied in order to detect differences in the incidence of contamination among assembly sites.


2019 ◽  
Vol 31 (1) ◽  
pp. 48-51
Author(s):  
Suha S Hassan ◽  
Nidhal H. Ghaib ◽  
Batool H Al-Ghurabi

Background: The microorganisms can impend the life of health care professional and particularly the dental practitioners. They can be transmitted by different ways like airborne and droplet transmission. The current study was carried out to identify whether the arch wires that received from the manufactures are free from microbial contamination and to determine the bacterial species attached to the arch wires. Materials and Methods: This study involved eighty samples, consisted of two types of arch wires (nitinol and stainless-steel) from four companies (3M, G&H, Jiscop, OrthoTechnology). These wires inserted in a plane tube that contains 10 -ml of (Tris [tris(hydroxymethyl)aminomethane] and EDTA (ethylenediaminetetraacetic acid) tris-EDTA and brain heart infusion (BHI) broth. A 0.1 ml was withdrawn from the tube and spread on agar plates. The control groups consist of 16 plane tube (8 tubes with tris-EDTA and other 8 tubes with (BHI). Results: Microbial sampling yielded growth from 5 of the 80 arch wires. The predominant bacteria that isolated were Bacillus spp. No growth was recovered from 75 of the samples and from controls. The bacteria were isolated by BHI reagent and no growth was observed by tris-EDTA reagent with statistically significant difference (P<0.05). The Bacillus spp. found only in the G&H and Jiscop companies, however, no statistically significant difference was found among them (P>0.05). With regard to the presence and distribution of bacteria according to the types of wires, the present results clarified that cases of contamination with Bacillus spp. were found in the nitinol arch wires with statistically significant difference (P<0.05). Conclusions: The results of the current study revealed low count of bacterial contamination in the two types of companies (G&H and Jiscop). Not all materials that received from the manufactures are free from contamination and an effective sterilization regimen is needed to avoid cross-contamination.


2020 ◽  
Vol 36 (3) ◽  
pp. 82-89
Author(s):  
O.V. Gromova ◽  
O.S. Durakova ◽  
S.V. Generalov ◽  
L.F. Livanova ◽  
O.A. Volokh

Том 36(2020) №3 стр. 82-89; DOI 10.21519/0234-2758-2020-36-3-82-89А.В. Гаева1*, О.В. Громова1, О.С. Дуракова1, С.В. Генералов1, Л.Ф. Ливанова1, О.А. Волох1 Определение специфической активности компонентов холерной химической вакцины с использованием культуры клеток 1ФКУЗ «Российский научно-исследовательский противочумный институт «Микроб»» Федеральной службы по надзору в сфере защиты прав потребителей и благополучия человека, Саратов 410005 *[email protected] Поступила - 2019-11-26; После доработки - 2020-03-16; Принята к публикации - 2020-05-15 Список литературы Описаны методы определения динамики продукции токсинов штаммом Vibrio cholerae 569B при глубинном культивировании в биореакторе и антигенной активности специфической фракции холерогена-анатоксина по анатоксинсвязыванию с использованием клеточных культур. Показана высокая степень соответствия результатов, полученных методами, применяемыми для контроля этапов производства холерной химической вакцины и рассмотренными в данной работе. Отмечено, что применение клеточной линии СНО-К1 наиболее перспективно для замены биомоделей на промежуточных этапах контроля активных компонентов холерной химической вакцины. Разработанный методический подход впервые предлагается использовать на этапах производства холерной бивалентной химической вакцины. культура клеток, Vibrio cholerae, холерная химическая вакцина, контроль производства, холера. Vol 36(2020) N 3 p. 82-89; DOI 10.21519/0234-2758-2020-36-3-82-89A.V. Gaeva1*, O.V. Gromova1, O.S. Durakova1, S.V. Generalov1, L.F. Livanova1, O.A. Volokh1 Determination of Specific Activity of Cholera Chemical Vaccine Components using Cell Culture 1Russian Research Anti-Plague Institute «Microbe» of the Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing, Saratov, 410005 *[email protected] Received - 26.11.2019; Accepted - 15.05.2020 References The methods has been described to determine the dynamics of toxin production by the Vibrio cholerae 569B strain during submerged cultivation in bioreactor and of the antigenic activity of specific choleragen anatoxin fraction by anatoxin binding levels using cell cultures. High degree of consistency was observed between the results obtained via the method under consideration and those obtained via control methods at different stages of cholera chemical vaccine production. It was shown that the CHO-K1 cell line is the most promising substitute for biomodels at the intermediate stages of control of active cholera chemical vaccine components. The developed methodological approach was first proposed for use at the stages of cholera chemical bivalent vaccine manufacturing. cell culture, Vibrio cholerae, cholera chemical vaccine, production control, cholera.


LWT ◽  
2021 ◽  
pp. 112129
Author(s):  
You Jin Kim ◽  
Ju Yeon Park ◽  
Soo Hwan Suh ◽  
Mi-Gyeong Kim ◽  
Hyo-Sun Kwak ◽  
...  

2018 ◽  
Vol 33 (6) ◽  
pp. 602-606
Author(s):  
Roohollah Farhadloo ◽  
Jalil Goodarzi Far ◽  
Mohammad Reza Azadeh ◽  
Saeed Shams ◽  
Mohammad Parvaresh-Masoud

AbstractBackgroundThe contamination of the environment, ambulance equipment, and staff hands consequently are major factors which create nosocomial infections in emergency patients. The contamination of equipment and devices plays an important role in nosocomial infections.ObjectivesThe aim of this study was to determine the effectiveness of a disinfectant on the rate of microbial contamination of ambulances in Qom Emergency Medical Services (EMS), Qom, Iran.MethodsThis is a quasi-experimental study with a before-after design in order to determine microbial contaminations at the rear and front cabin of ambulances, as well as medical equipment being utilized in Qom EMS. Saya sept-HP-2% solution was used for disinfection. Bacteriological standard methods were used to identify the contaminations.ResultsThe contamination rates before and after use of disinfection solution were 52% and eight percent, respectively. Coagulase-negative staphylococci were the most commonly isolated bacterial agent from the equipment (53%). In all equipment, the contamination level has shown a significant reduction after applying disinfectant.Conclusions:In spite of the fact that the rate of infection from ambulance equipment is high, the results showed that the use of the suitable disinfectant had an effective role in the reduction of bacteria.FarhadlooR, Goodarzi FarJ, AzadehMR, ShamsS, Parvaresh-MasoudM.Evaluation of bacterial contamination on prehospital ambulances before and after disinfection. Prehosp Disaster Med. 2018;33(6):602–606.


Author(s):  
Silvana POPESCU ◽  
Cristin BORDA ◽  
Cristina EL MAHDY ◽  
Eva Andrea LAZAR ◽  
Anamaria BLAGA PETREAN ◽  
...  

The aim of this work was the investigation of the effect of bedding type on the airborne concentration of bacteria and fungi in broiler houses. The study was performed in two commercial farms (A and B) with different bedding (chopped straw in farm A, sunflower seed hulls in farm B). The determination of the bacteria and fungi’s numbers was performed in the first and the sixth weeks of the production cycle. Both the concentration of the bacteria and fungi showed higher values in the farm A compared with the farm B, especially in the latter period of the production cycle. In both farms, significant differences (P < 0.05) were recorded between the two periods of the determinations. The results of this study suggest that using sunflower seed hulls as bedding leads to lower levels of microbial contamination of the air in broiler houses, comparing with the use of chopped straw.


1975 ◽  
Vol 9 (2) ◽  
pp. 135-138
Author(s):  
G. Ya. Kivman ◽  
G. A. Sapozhnikova ◽  
K. A. Kagramanova ◽  
N. I. Kalamova ◽  
S. S. Bikaeva

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