Use of Biological Indicators Designed for Stream or Ethylene Oxide to Monitor a Liquid Chemical Sterilization Process

1993 ◽  
Vol 14 (6) ◽  
pp. 313-319 ◽  
Author(s):  
Raymond C. Kralovic

AbstractObjective:To determine the ability of a commercially available biological indicator (BI), used to monitor steam and ethylene oxide sterilization, to biologically monitor a liquid sterilization process consisting of a sterile processor, a proprietary peracetic acid sterilant, and a sterile rinse system.Design:Analysis of spore survival in BIs tested in STERIS SYSTEM 1™ liquid chemical sterilization processor and in vitro.Setting:STERIS Corp. research laboratory.Methods:In vitro tests were performed in the STERIS SYSTEM 1 Processor using 12-minute and 6-minute sterilant exposure cycles. D values (time to inactivate one log of spores), spore washoff and outgrowth time, and inhibitory effects of the sterilant were determined.Results:Sterilization of the spore-inoculated filter paper strips in the BIs was ascertained in both processor testing and in vitro tests using conditions identical to those in the processor. The extensive washing and dilution during the processor cycle resulted in only 0.2% and 1.8% removal of the spores from Bacillus stearother-mophilus and Bacillus subtilis inoculated spore strips, respectively.Carryover of the diluted sterilant to the culture medium did not inhibit the outgrowth of the spores, and D values could be obtained. B Stearothermophilus was two to three times more resistant to the sterilant than B subtilis. However, either spore meets the performance specifications applicable to BIs for monitoring sterilization processes.Conclusions:The data demonstrate that the commercial Bis evaluated are reproducible and verifiable indicators of the liquid chemical sterilization process. The same kind of performance specifications for producing BIs used to monitor steam or ethylene oxide systems also apply to the evaluated liquid chemical sterilization system.

2020 ◽  
Vol 4 (Supplement_1) ◽  
Author(s):  
Jose Gilberto Vieira ◽  
Guilherme Okai ◽  
Cláudia Ferrer ◽  
Karina Cardozo

Abstract Recently, the use of Vitamin D in high doses for treatment of several conditions, mainly autoimmune in nature, has been advocated with dubious results. Hypercalcemia is an important side effect of this intervention. Here we describe our findings in samples that presented 25(OH)D in excess of 150 ng/mL (375 nmol/L) and had 1,25(OH)2D also measured. Material and Methods: we used serum samples from our diagnostic routine, received for measurement of 25(OH)D and 1,25(OH)2D according to medical requisition. A first group (group A) included 213 samples collected up to November 2018, used Diasorin’s chemiluminescent assays for 25OHD and 1,25(OH)2D, and a second group (group B), comprising 88 samples, used the same 25(OH)D assay and LC-MS/MS method for 1,25(OH)2D. 1,25(OH)2D measurement in the group A used a chemiluminescent competitive assay (Liason XL, Diasorin). The 1,25(OH)2D LC-MS/MS assay includes a previous sample prep, extraction, derivatization and chromatrography. APCI+ is followed by SRM (Selected Reaction Monitoring) and CAD (Collision Activated Dissociation) fragmentation. Precision studies showed, between run CVs of 6.8% to 7.4% and within run of 2.9% to 5.5%. In vitro investigations testing standards and spiked samples with 25(OH)D3, 25(OH)D2, 3-epimer-25(OH)D3 and 24R,25(OH)2D3 were also used to verify possible analytical interferences in the 1,25(OH)2D LC-MS/MS. Results: in group A, 25(OH)D median was 371 ng/mL (928 nmol/L), range 154 ng/mL to 856 ng/mL; 1,25(OH)2D median of 350 pg/mL (875 pmol/L), range 41 pg/mL to 1280 pg/mL. Correlation (Spearman) between 25(OH)D and 1,25(OH)2 was r= 0.8649 (P<0.001). In group B, 25(OH)D showed a median of 349 ng/mL (872 nmol/L), range 171 to 756 ng/mL; 1,25(OH)2D median of 54 pg/mL (135 pmol/L), range 24 pg/mL to 108 pg/mL. Correlation between 25(OH)D and 1,25(OH)2 was r= 0.185 (P= 0.08). In group A 189 samples had calcium measurement (median 9.7 mg/dL, range of 8.7 to 13.6 mg/dL), 182 creatinine (median of 0.8 mg/dL range of 0.3 to 1.8 mg/dL) and 179 PTH (median 19 pg/mL, range 5 to 68 pg/mL). In group B 75 cases had measurements of calcium (median 9.7, range 8.6 to 16.6 mg/dL), 75 of creatinine (median 0.8, range 0.3 to 2.5 mg/dL) and 75 of PTH (median 20, range 9 to 49 pg/mL). The in vitro tests showed a slight interference from 25(OH)D3, 3-epimer-25(OH)D3 and 24R,25(OH)2D3 molecules in the LC-MS/MS method. Conclusion: our results confirm data already published showing interference of high levels of 25(OH)D in 1,25(OH)2D measured by immunoassay and, in a milder way, by LC-MS/MS (1). V. Care should be taken in the interpretation of 1,25(OH)2D values in samples with high 25(OH)D values. 1. Hawkes CP, Schnellbacher S, Singh RJ, Levine MA. 25-Hydroxyvitamin D can interfere with a common assay for 1,25-dihydroxyvitamin D in vitamin D intoxication. J Clin Endocrinol Metab. 2015; 100:2883-2889.


2011 ◽  
Vol 81 (1) ◽  
pp. 34-42 ◽  
Author(s):  
Joel Deneau ◽  
Taufeeq Ahmed ◽  
Roger Blotsky ◽  
Krzysztof Bojanowski

Type II diabetes is a metabolic disease mediated through multiple molecular pathways. Here, we report anti-diabetic effect of a standardized isolate from a fossil material - a mineraloid leonardite - in in vitro tests and in genetically diabetic mice. The mineraloid isolate stimulated mitochondrial metabolism in human fibroblasts and this stimulation correlated with enhanced expression of genes coding for mitochondrial proteins such as ATP synthases and ribosomal protein precursors, as measured by DNA microarrays. In the diabetic animal model, consumption of the Totala isolate resulted in decreased weight gain, blood glucose, and glycated hemoglobin. To our best knowledge, this is the first description ever of a fossil material having anti-diabetic activity in pre-clinical models.


1991 ◽  
Vol 66 (05) ◽  
pp. 609-613 ◽  
Author(s):  
I R MacGregor ◽  
J M Ferguson ◽  
L F McLaughlin ◽  
T Burnouf ◽  
C V Prowse

SummaryA non-stasis canine model of thrombogenicity has been used to evaluate batches of high purity factor IX concentrates from 4 manufacturers and a conventional prothrombin complex concentrate (PCC). Platelets, activated partial thromboplastin time (APTT), fibrinogen, fibrin(ogen) degradation products and fibrinopeptide A (FPA) were monitored before and after infusion of concentrate. Changes in FPA were found to be the most sensitive and reproducible indicator of thrombogenicity after infusion of batches of the PCC at doses of between 60 and 180 IU/kg, with a dose related delayed increase in FPA occurring. Total FPA generated after 100-120 IU/kg of 3 batches of PCC over the 3 h time course was 9-12 times that generated after albumin infusion. In contrast the amounts of FPA generated after 200 IU/kg of the 4 high purity factor IX products were in all cases similar to albumin infusion. It was noted that some batches of high purity concentrates had short NAPTTs indicating that current in vitro tests for potential thrombogenicity may be misleading in predicting the effects of these concentrates in vivo.


1980 ◽  
Vol 44 (02) ◽  
pp. 081-086 ◽  
Author(s):  
C V Prowse ◽  
A E Williams

SummaryThe thrombogenic effects of selected factor IX concentrates were evaluated in two rabbit models; the Wessler stasis model and a novel non-stasis model. Concentrates active in either the NAPTT or TGt50 in vitro tests of potential thrombogenicity, or both, caused thrombus formation in the Wessler technique and activation of the coagulation system in the non-stasis model. A concentrate with low activity in both in vitro tests did not have thrombogenic effects in vivo, at the chosen dose. Results in the non-stasis model suggested that the thrombogenic effects of factor IX concentrates may occur by at least two mechanisms. A concentrate prepared from platelet-rich plasma and a pyrogenic concentrate were also tested and found to have no thrombogenic effect in vivo.These studies justify the use of the NAPTT and TGt50 in vitro tests for the screening of factor IX concentrates prior to clinical use.


1979 ◽  
Vol 42 (05) ◽  
pp. 1355-1367 ◽  
Author(s):  
C V Prowse ◽  
A Chirnside ◽  
R A Elton

SummaryVarious factor IX concentrates have been examined in a number of in vitro tests of thrombogenicity. The results suggest that some tests are superfluous as in concentrates with activity in any of these tests activation is revealed by a combination of the non-activated partial thromboplastin time, the thrombin (or Xa) generation time and factor VIII inhibitor bypassing activity tests. Assay of individual coagulant enzymes revealed that most concentrates contained more factor IXa than Xa. However only a small number of concentrates, chiefly those that had been purposefully activated, contained appreciable amounts of either enzyme.


1963 ◽  
Vol 10 (01) ◽  
pp. 106-119 ◽  
Author(s):  
E Beck ◽  
R Schmutzler ◽  
F Duckert ◽  

SummaryInhibitor of kallikrein and trypsin (KI) extracted from bovine parotis was compared with ε-aminocaproic acid (EACA): both substances inhibit fibrinolysis induced with streptokinase. EACA is a strong inhibitor of fibrinolysis in concentrations higher than 0, 1 mg per ml plasma. The same amount and higher concentrations are not able to inhibit completely the proteolytic-side reactions of fibrinolysis (fibrinogenolysis, diminution of factor V, rise of fibrin-polymerization-inhibitors). KI inhibits well proteolysis of plasma components in concentrations higher than 2,5 units per ml plasma. Much higher amounts of KI are needed to inhibit fibrinolysis as demonstrated by our in vivo and in vitro tests.Combination of the two substances for clinical use is suggested. Therapeutic possibilities are discussed.


HortScience ◽  
1998 ◽  
Vol 33 (3) ◽  
pp. 469a-469
Author(s):  
L.J. Skog ◽  
D.P. Murr ◽  
B.E. Digweed

Volatile compounds are ubiquitous in plants, giving fruits their characteristic aroma and flavor. There is increasing evidence that these compounds can protect plants from pathogenic organisms. In this trial ≈25 volatile compounds were tested for efficacy against Monilinia fructicola and Penicillium expansum. Both in vitro tests on agar plugs of actively growing pathogens and in situ tests on inoculated stone fruits and pears were conducted. The volatile compounds were grouped into three categories based upon fungicidal activity in vitro: highly effective (fungicidal concentration ≤100 M), moderately effective (fungicidal concentration between 100–200 M) and ineffective (fungicidal concentration >200 M). Highly effective compounds included: acetaldehyde, citral, 2-ethyl-1-hexanol, 2,exadienal, E-2-hexenal, 4-hexen-3-one, linalool, (E,E)2,4-nonadienal, E-2-nonenal, E-3-none-2-one, salicylaldehyde, and valeraldehyde. Moderately effective compounds included: (E,Z) 2,6-nonadienal, propionaldehyde, terpinene, butyl acetate, E-cinnamaldehde, hexanal, E-2-hexen-1-ol, Z-3-hexen-1-ol and isoamyl acetate. Ineffective compounds included: butyrolactone, ethanol, ethyl acetate, and methyl acetate. Effectiveness of the compounds varied with both strain and type of microorganism tested. Concentraions required for effective control were much higher when the compounds were tested on inoculated fruit. Phytotoxicity was a problem with some compounds.


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