scholarly journals Dose Setting for Radiation Sterilization of Dialyzers(II) : Measurement of D-Value of Spores Inoculated in Dialyzers as Biological Indicator

1986 ◽  
Vol 56 (9) ◽  
pp. 415-419
Author(s):  
Akiko KIGAWA ◽  
Sho MISAWA ◽  
Tsuneo TATEISHI ◽  
Katsuaki ISO ◽  
Toshio KIMURA ◽  
...  
Keyword(s):  
Biological Indicator ◽  
Radiation Sterilization ◽  
D Value

scholarly journals Stability of Biological Indicator Used for Monitoring Radiation Sterilization

1985 ◽  
Vol 55 (6) ◽  
pp. 293-300
Author(s):  
Tsuneo TATEISHI ◽  
Akiko KIGAWA ◽  
Toshio KIMURA ◽  
Tetsuo MAMURO
Keyword(s):  
Biological Indicator ◽  
Radiation Sterilization

STUDYING THE EFFICIENCY OF MOIST HEAT STERILIZATION VALIDATION PROCESS

2012 ◽  
pp. 62-65
Author(s):  
Van Dat Truong ◽  
Quang Duong Do ◽  
Van Hoa Huynh
Keyword(s):  
Real Time ◽  
Biological Indicator ◽  
Validation Process ◽  
Process Validation ◽  
The Real ◽  
Moist Heat ◽  
Survey Results ◽  
Sterilization Process ◽  
Z Value ◽  
D Value

Background: Moist Heat Sterilization validation process comprises several steps. The IQ, OQ have to follow the specified SOPs of manufacturer or equipment supplier. However, the efficiency of the sterilization process must be expressed in numberized values based on sterilization coefficient D, Z value, F value and SAL value. Materials and methods: Studying to calculate the total Moist Heat Sterilization time based on the survey results process validation at 13 pharmaceutical factories having chains of sterile drugs and the other published documents. Results: The researched results were calculated the total sterilization time C (if the assumption that SAL = 10-6), this time will be compared with the real time of the process. Conclusion: The real time of the sterilization process is as similar as the C value, the efficiency of sterilization process is highlier. Keywords: Sterile drug, Moist Heat Sterilization, D value, Z value, F value, Biological indicator, process validation. Key words: Sterile drug, Moist Heat Sterilization, D value, Z value, F value, Biological indicator, process validation

STUDYING THE PARAMETERS THAT AFFECT THE EFFICIENCY OF THE STERILIZATION PROCESS VALIDATION

2012 ◽  
pp. 42-46
Author(s):  
Van Dat Truong ◽  
Quang Duong Do ◽  
Van Hoa Huynh
Keyword(s):  
Execution Time ◽  
Biological Indicator ◽  
Calculation Formula ◽  
Process Validation ◽  
Iso Standards ◽  
Drug Products ◽  
Survey Results ◽  
Sterilization Process ◽  
Z Value ◽  
D Value

Background: Sterility is required for sterile drug products so they must be sterilized by the sterilization process has been validated. Demonstrating the efficiency of the sterilization process can not only base on the results of sterility tests but also must calculate many other parameters. Calculating SAL will increase the assurance, the efficiency of the sterilization process and save execution time. Materials and methods: Studying the parameters that affect the efficiency of the sterilization process validation. Basing on survey results process validation at 13 pharmaceutical factories having chains of sterile drugs to identify the parameters that affect the result validation and compare with ISO standards, USP,… to find the calculation formula. Results: Identified the parameters that affect the efficiency of the sterilization process validation and fomular to calculate these parameters. Conclusion: D, F, Z, SLR, SAL values are the important parameters that are determined in the efficiency of the sterilization process validation. Keywords: D value, F value, Z value, Sterile drug, Sterilization, Biological indicator, process validation.

scholarly journals Effect of Sporulation Conditions Following Submerged Cultivation on the Resistance of Bacillus atrophaeus Spores against Inactivation by H2O2

Molecules ◽  
2020 ◽  
Vol 25 (13) ◽  
pp. 2985
Author(s):  
Philipp Stier ◽  
Ulrich Kulozik
Keyword(s):  
Hydrogen Peroxide ◽  
Biological Indicator ◽  
Submerged Cultivation ◽  
Bacillus Atrophaeus ◽  
Random Variability ◽  
Aseptic Packaging ◽  
Safe Food ◽  
D Values ◽  
Shelf Stable ◽  
D Value

The resistance formation of spores in general and of Bacillus atrophaeus in particular has long been the focus of science in the bio-defense, pharmaceutical and food industries. In the food industry, it is used as a biological indicator (BI) for the evaluation of the inactivation effects of hydrogen peroxide in processing and end packaging lines’ sterilization. Defined BI resistances are critical to avoid false positive and negative tests, which are salient problems due to the variable resistance of currently available commercial BIs. Although spores for use as BIs have been produced for years, little is known about the influence of sporulation conditions on the resistance as a potential source of random variability. This study therefore examines the dependence of spore resistance on the temperature, pH and partial oxygen saturation during submerged production in a bioreactor. For this purpose, spores were produced under different sporulation conditions and their resistance, defined by the D-value, was determined using a count reduction test in tempered 35% liquid hydrogen peroxide. The statistical analysis of the test results shows a quadratic dependence of the resistance on the pH, with the highest D-values at neutral pH. The sporulation temperature has a linear influence on the resistance. The higher the temperature, the higher the D-value. However, these factors interact with each other, which means that the temperature only influences the resistance when the pH is within a certain range. The oxygen partial pressure during sporulation has no significant influence. Based on the data obtained, a model could be developed enabling the resistance of BIs to be calculated, predicted and standardized depending on the sporulation conditions. BI manufacturers could thus produce BIs with defined resistances for the validation of sterilization effects in aseptic packaging/filling lines for the reliable manufacture of shelf-stable and safe food products.

scholarly journals Clean-Test self-contained biological indicator performance used to steam sterilization process validation.

2012 ◽  
Vol 2 (1) ◽  
pp. 38
Author(s):  
Thiago José Pelissari ◽  
Heron Oliveira dos Santos Lima ◽  
Mirela Vanin dos Santos Lima
Keyword(s):  
Incubation Time ◽  
Time Pressure ◽  
Biological Indicators ◽  
Biological Indicator ◽  
Initial Population ◽  
Steam Sterilization ◽  
Microbial Resistance ◽  
Decimal Reduction Time ◽  
D Value

<p>Clean-Test self-contained biological indicators are used to monitor steam sterilization cycles. Each biological indicator has a minimum population of 10<sup>5</sup> or 10<sup>6</sup> UFC bacterial spores of <em>Geobacillus stearothermophilus</em> ATCC 7953. The purpose of this work was to study the behavior of Clean-Test self-contained biological indicator used to monitor and validate steam sterilization systems, in relation to the incubation time (24, 48 hours and 7 days) and the performance of microbial resistance at different conditions of time, pressure and temperature. The analyses were performed starting with the evaluation of lots of biological indicators by determining the initial population (N<sub>0</sub>), determination of D value (decimal reduction time), determination of survival and death times for the microorganisms. Then&nbsp; was studied the resistance performance&nbsp; of the biological indicator Clean-Test at different exposure times, temperatures and pressure, as well as the evaluation and analysis of the relationship between incubation time and growth rate for periods of 24, and 48 hours 7 days. The behavior of biological indicator when the temperature and pressure were increased was inversely proportional to D value (microbial resistance). The lot behavior of positive biological indicators by the end of seven days of incubation indicated minimal results of 97%, satisfactory acceptability which is acceptable according to ANSI/AAMI/ISO 11138-1:(2006)because the lots of biological indicators tested met its requirements.</p><p>&nbsp;</p><p>DOI: http://dx.doi.org/10.14685/rebrapa.v2i1.45</p>

Effects of sterilization modes on the mechanical strengths of plaster of paris implants

1989 ◽  
Vol 47 ◽  
pp. 890-891
Author(s):  
K. Cowden ◽  
B. Giammara ◽  
T. Devine ◽  
J. Hanker
Keyword(s):  
Gamma Radiation ◽  
Calcium Sulfate ◽  
Significant Loss ◽  
Potassium Sulfate ◽  
Limiting Factors ◽  
Radiation Sterilization ◽  
Plaster Of Paris ◽  
Hardness Tester ◽  
Dry Heat ◽  
Calcium Sulfate Hemihydrate

Plaster of Paris (calcium sulfate hemihydrate, CaSO4. ½ H2O) has been used as a biomedical implant material since 1892. One of the primary limiting factors of these implants is their mechanical properties. These materials have low compressive and tensile strengths when compared to normal bone. These are important limiting factors where large biomechanical forces exist. Previous work has suggested that sterilization techniques could affect the implant’s strength. A study of plaster of Paris implant mechanical and physical properties to find optimum sterilization techniques therefore, could lead to a significant increase in their application and promise for future use as hard tissue prosthetic materials.USG Medical Grade Calcium Sulfate Hemihydrate Types A, A-1 and B, were sterilized by dry heat and by gamma radiation. Types A and B were additionally sterilized with and without the setting agent potassium sulfate (K2SO4). The plaster mixtures were then moistened with a minimum amount of water and formed into disks (.339 in. diameter x .053 in. deep) in polyethylene molds with a microspatula. After drying, the disks were fractured with a Stokes Hardness Tester. The compressive strengths of the disks were obtained directly from the hardness tester. Values for the maximum tensile strengths σo were then calculated: where (P = applied compression, D = disk diameter, and t = disk thickness). Plaster disks (types A and B) that contained no setting agent showed a significant loss in strength with either dry heat or gamma radiation sterilization. Those that contained potassium sulfate (K2SO4) did not show a significant loss in strength with either sterilization technique. In all comparisons (with and without K2SO4 and with either dry heat or gamma radiation sterilization) the type B plaster had higher compressive and tensile strengths than that of the type A plaster. The type A-1 plaster however, which is specially modified for accelerated setting, was comparable to that of type B with K2SO4 in both compressive and tensile strength (Table 1).

A Standard Primary Toxicity Bioassay Using Daphnia Magna as a Test Species

1977 ◽  
Vol 12 (1) ◽  
pp. 27-50 ◽  
Author(s):  
L.A. Behie ◽  
J.E. Zajic ◽  
D. Berk ◽  
R.J.P. Brouzes ◽  
V.A. Naish
Keyword(s):  
Statistical Analysis ◽  
Daphnia Magna ◽  
Biological Indicator ◽  
Pulp And Paper ◽  
Toxicity Bioassay ◽  
Simple Method ◽  
Test Species ◽  
Test Organisms ◽  
Dilution Water

Abstract Although Daphnia magna have been widely used in the determination of the toxicity of various substances, there are no reports in the literature that describe a rigorous bioassay method using this organism as a test species. The test described herein involves the standariza-tion of various important aspects of the method such as the age of the test organisms, and the dilution water used for the preparation of the various toxicant concentrations. Also described is a simple method for the statistical analysis of the results. The sensitivity of the proposed bioassay is demonstrated by determining the toxicity of various pulp and paper effluents. Finally, extensive bioassays were carried out simultaneously with rainbow trout and Daphnia magna indicating that Daphnia are as good a biological indicator of acute toxicity as fish.

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