Journal of parenteral science and technology : a publication of the Parenteral Drug Association最新文献

Simplifying and improving process validation. 简化和改进工艺验证。

Journal of parenteral science and technology : a publication of the Parenteral Drug Association Pub Date : 1993-11-01

J Akers

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Factors affecting recovery of Neosartorya fischeri ascospores after exposure to dry heat. 干热处理后影响鱼新树子囊孢子恢复的因素。

Journal of parenteral science and technology : a publication of the Parenteral Drug Association Pub Date : 1993-11-01

M M Gómez, I J Pflug, F F Busta

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Particle contamination in a ternary nutritional admixture. 三元营养混合物中的颗粒污染。

Journal of parenteral science and technology : a publication of the Parenteral Drug Association Pub Date : 1993-11-01

L A Foroni, M H Rochat, P Trouiller, J Y Calop

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Optimization of moist heat sterilization. 优化湿热灭菌。

Journal of parenteral science and technology : a publication of the Parenteral Drug Association Pub Date : 1993-11-01

J P Mannermaa, J Yliruusi

{"title":"Optimization of moist heat sterilization.","authors":"J P Mannermaa, J Yliruusi","doi":"","DOIUrl":"","url":null,"abstract":"The use of different combinations of sterilization time and temperature in a pilot scale autoclave, GEV 612 AR-2 (Getinge Ab, Sweden), in optimizing the sterilization process was studied. All three programs used had the same sterilization efficacy (F0 = 15 minutes) but different sterilization temperatures (116, 121, and 126 degrees C) and total process times (98, 57, and 44 minutes). The heat distribution during the sterilization phase was, in all cases, very uniform, the greatest difference being 0.5 degrees C. Also the F0 values differed only by +/- 0.5 minutes from each other. The F0 value increases linearly with all programs until the beginning of the cooling phase. The main effect of different sterilization temperatures on the cumulative F0 curves is an increase in the slope of the curves with increasing sterilization temperature. First order temperature change constants were determined both for the heating phase and the cooling phase. The numeric values of the rate constants for the heating and the cooling phases were 0.20 +/- 0.03 and 0.046 +/- 0.005 min-1, respectively. It is concluded that the pilot autoclave used in this study controls the sterilization process very accurately. The observed variations between F0 values at different positions in the autoclave chamber are acceptable. On the basis of this study an accurately engineered and controlled autoclave is required in process optimization. It also is possible to use higher sterilization temperatures than usually suggested in pharmacopeias and thus to shorten the process time.","PeriodicalId":16667,"journal":{"name":"Journal of parenteral science and technology : a publication of the Parenteral Drug Association","volume":"47 6","pages":"306-10"},"PeriodicalIF":0.0,"publicationDate":"1993-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"19113204","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Evaluating out-of-specification laboratory results. 评估不合格的实验室结果。

Journal of parenteral science and technology : a publication of the Parenteral Drug Association Pub Date : 1993-11-01

P F Vogel

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USP perspectives on particle contamination of injectable products. 美国药典对注射产品颗粒污染的看法。

Journal of parenteral science and technology : a publication of the Parenteral Drug Association Pub Date : 1993-11-01

J F Gallelli, M J Groves

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Moisture measurement: a new method for monitoring freeze-drying cycles. 水分测量:一种监测冷冻干燥循环的新方法。

Journal of parenteral science and technology : a publication of the Parenteral Drug Association Pub Date : 1993-11-01

A Bardat, J Biguet, E Chatenet, F Courteille

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Depyrogenation of pharmaceutical solutions using submicron and ultrafilters. 使用亚微米和超滤的药物溶液去热原。

Journal of parenteral science and technology : a publication of the Parenteral Drug Association Pub Date : 1993-11-01

S Brown, A C Fuller

{"title":"Depyrogenation of pharmaceutical solutions using submicron and ultrafilters.","authors":"S Brown, A C Fuller","doi":"","DOIUrl":"","url":null,"abstract":"The effect of varying the pH and ionic strength on endotoxin removal (depyrogenation) from Water for Injections (WFI) was investigated. Studies using submicron filters showed that endotoxin aggregation and filter retention increased with increasing molarity and decreasing pH. Using a Sartorius 0.01 micron filter, greater than 98% endotoxin retention could be achieved with 10 endotoxin units (EU)/ml bulk solution, and greater than 97% endotoxin retention with the 500 EU/ml bulk solution. Depyrogenation of active and placebo solutions of the radiopaque, Iohexol (350 mgI/ml), using ultrafilters of varying nominal molecular weight limit (NMWL 10,000-300,000) and a Pall Posidyne 0.2 micron filter was also investigated. Results with the ultrafilters showed that it was possible to increase the molecular weight cut-off of an ultrafilter from 10,000 to 100,000, without affecting the efficiency of endotoxin removal, thereby increasing flow rate and reducing filtration time. The Posidyne filter was able to depyrogenate Iohexol active and placebo product. The use of submicron filtration in place of ultrafiltration would provide significant cost benefits in terms of filtration time and equipment costs, and they have been shown to be capable of efficient depyrogenation of these pharmaceutical products.","PeriodicalId":16667,"journal":{"name":"Journal of parenteral science and technology : a publication of the Parenteral Drug Association","volume":"47 6","pages":"285-7"},"PeriodicalIF":0.0,"publicationDate":"1993-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"19112699","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

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Destruction of typical endotoxins by dry heat as determined using LAL assay and pyrogen assay. 用LAL法和热原法测定干热对典型内毒素的破坏。

Journal of parenteral science and technology : a publication of the Parenteral Drug Association Pub Date : 1993-09-01

T Nakata

{"title":"Destruction of typical endotoxins by dry heat as determined using LAL assay and pyrogen assay.","authors":"T Nakata","doi":"","DOIUrl":"","url":null,"abstract":"The kinetics of destruction by dry heat of two typical endotoxins, Escherichia coli 055:B5 (E. coli endotoxin) and Salmonella abortus equi (S. abortus equi endotoxin), were determined using the Limulus Amebocyte Lysate (LAL) and pyrogen assays. The efficiency of recovery of these endotoxins from carriers using a pyrogen assay was also determined simultaneously. In the LAL assay 0.1-10,000 EU was used and 10-1000 EU in the pyrogen assay. Recoveries of E. coli endotoxin and S. abortus equi endotoxin were, respectively, 49.7-92.0% and 27.0-70.1% by the LAL assay, and 31.1% and 60.6% by the pyrogen assay. Fourier transformation infrared (FT-IR) spectra demonstrated the presence of chemical structural differences between the two endotoxins. By dry heat (200 or 250 degrees C), there were no significant differences in the destruction kinetics between the two endotoxins; either endotoxin can therefore be adapted for use in the endotoxin challenge test. Destruction in the pyrogen assay was significantly quicker than that predicted by the LAL assay for each of the two endotoxins. In this endotoxin destruction system, 3 log cycle reduction (the United State Pharmacopeia (USP) recommendation for the depyrogenation process) could not be obtained by challenge with 10,000 EU of endotoxin under the depyrogenation conditions of 200 degrees C for 60 min (a set of conditions described in the European Pharmacopoeia (EP)), though little pyrogenicity remained. On the other hand, at 250 degrees C for 30 min (a set of conditions described in the EP, USP and Pharmacopoeia of Japan (JP)),a 3 log cycle reduction was achieved without any pyrogenicity remaining.","PeriodicalId":16667,"journal":{"name":"Journal of parenteral science and technology : a publication of the Parenteral Drug Association","volume":"47 5","pages":"258-64"},"PeriodicalIF":0.0,"publicationDate":"1993-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"19251317","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

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An approach to the determination of endotoxin in anesthetics and antibiotics: use of an ultrafiltration system and enzymatic LAL reaction. 麻醉药和抗生素中内毒素的测定方法:超滤系统和酶促LAL反应的应用。

Journal of parenteral science and technology : a publication of the Parenteral Drug Association Pub Date : 1993-09-01

H Justicia, M Ibañez

引用次数: 0