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

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Comparison of different rubber stoppers; the effect of sterilization on the number of particles released. 不同橡胶塞的比较;灭菌对颗粒释放数量的影响。
Journal of parenteral science and technology : a publication of the Parenteral Drug Association Pub Date : 1992-05-01
J P Mannermaa, E Muttonen, J Yliruusi, A Juppo
{"title":"Comparison of different rubber stoppers; the effect of sterilization on the number of particles released.","authors":"J P Mannermaa,&nbsp;E Muttonen,&nbsp;J Yliruusi,&nbsp;A Juppo","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The effect of sterilization on the number of particles released from five different types of rubber stoppers, as well as on their surface roughness and elemental composition before and after sterilization is described. The stoppers were immersed in 200 ml of 0.9% sodium chloride solution in conical flasks. The number of particles released into the sodium chloride solution was measured by Coulter Counter. The surface roughness and the elemental composition of the stoppers were determined by SEM/EDX. All measurements were made both before and after sterilization at 121 degrees C to F0 15 mins. The number of particles released from a stopper during sterilization varies considerably between different stoppers and even between different batches of the same stopper. The only non-siliconized stopper in this study performed well. The absence of surface siliconization may have contributed to this performance. The scanning electron micrographs revealed well the differences in the surface roughness of the stoppers. The sterilization generally increases the surface roughness of the samples. The x-ray microanalysis revealed that the elemental composition of the stoppers may vary not only between different types of stoppers but also between different batches of the same stopper.</p>","PeriodicalId":16667,"journal":{"name":"Journal of parenteral science and technology : a publication of the Parenteral Drug Association","volume":"46 3","pages":"73-7"},"PeriodicalIF":0.0,"publicationDate":"1992-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"12691109","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
Importance of "good" basic science and of mathematical rigour. “好的”基础科学和数学严谨性的重要性。
Journal of parenteral science and technology : a publication of the Parenteral Drug Association Pub Date : 1992-05-01
J Sharp
{"title":"Importance of \"good\" basic science and of mathematical rigour.","authors":"J Sharp","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":16667,"journal":{"name":"Journal of parenteral science and technology : a publication of the Parenteral Drug Association","volume":"46 3","pages":"64"},"PeriodicalIF":0.0,"publicationDate":"1992-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"12651975","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
Pre-approval inspection program for drugs. 药品批准前检验程序。
Journal of parenteral science and technology : a publication of the Parenteral Drug Association Pub Date : 1992-05-01
G F Meyer
{"title":"Pre-approval inspection program for drugs.","authors":"G F Meyer","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":16667,"journal":{"name":"Journal of parenteral science and technology : a publication of the Parenteral Drug Association","volume":"46 3","pages":"98-9"},"PeriodicalIF":0.0,"publicationDate":"1992-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"12691018","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
Variability in the LAL test: comparison of three kinetic methods for the testing of pharmaceutical products. LAL试验的变异性:三种动力学方法在药品检验中的比较。
Journal of parenteral science and technology : a publication of the Parenteral Drug Association Pub Date : 1992-05-01
K Z McCullough, C Weidner-Loeven
{"title":"Variability in the LAL test: comparison of three kinetic methods for the testing of pharmaceutical products.","authors":"K Z McCullough,&nbsp;C Weidner-Loeven","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Data presented in this study indicate that there is considerable variability in spike recoveries between three different kinetic LAL methods as used for the testing of a variety of parenteral products. However, successful spike recoveries were observed for each of the thirteen products under test on at least one of the three kinetic methods used, suggesting that problems caused by spike recovery variability may be easily controlled in the laboratory by flexibility in the choice of method.</p>","PeriodicalId":16667,"journal":{"name":"Journal of parenteral science and technology : a publication of the Parenteral Drug Association","volume":"46 3","pages":"69-72"},"PeriodicalIF":0.0,"publicationDate":"1992-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"12691107","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
Industry perspective on the validation of column-based separation processes for the purification of proteins. Parenteral Drug Association. 基于柱的分离工艺纯化蛋白质的验证的行业观点。注射药物协会。
Journal of parenteral science and technology : a publication of the Parenteral Drug Association Pub Date : 1992-05-01
{"title":"Industry perspective on the validation of column-based separation processes for the purification of proteins. Parenteral Drug Association.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Validation of column-based separations is necessary to ensure the quality and safety of protein and peptide products produced by rDNA, peptide synthesis, and hybridoma technologies. Process validation for column-based separations includes qualification of raw materials, equipment, and the purification process. Combined with in-process control and quality control of the final product, column validation ensures that a uniform product is produced consistently from batch to batch. In the best case, validation is designed into the process. During process design, techniques are selected which can remove impurities and contaminants. Equipment and chromatographic media which can perform reproducibly are selected. Column performance standards, cleaning and regeneration routines, and column life should be considered as early as possible. Clearance studies should be planned and implemented to ensure that a product is produced with the requisite purity. There are no explicit rules for process validation of column-based separation processes. This document is intended to serve as a starting point for those needing to validate column-based separation processes.</p>","PeriodicalId":16667,"journal":{"name":"Journal of parenteral science and technology : a publication of the Parenteral Drug Association","volume":"46 3","pages":"87-97"},"PeriodicalIF":0.0,"publicationDate":"1992-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"12691114","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
PDA response. FDA proposal to amend cGMP's entitled--use of aseptic processing and terminal sterilization in the preparation of sterile pharmaceuticals for human and veterinary use. Parenteral Drug Association. PDA的回应。FDA建议修改cGMP标题——人用和兽用无菌药品制备中无菌处理和终端灭菌的使用。注射药物协会。
Journal of parenteral science and technology : a publication of the Parenteral Drug Association Pub Date : 1992-05-01
{"title":"PDA response. FDA proposal to amend cGMP's entitled--use of aseptic processing and terminal sterilization in the preparation of sterile pharmaceuticals for human and veterinary use. Parenteral Drug Association.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":16667,"journal":{"name":"Journal of parenteral science and technology : a publication of the Parenteral Drug Association","volume":"46 3","pages":"65-8"},"PeriodicalIF":0.0,"publicationDate":"1992-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"12691116","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
Lyophilization closures for protein based drugs. 蛋白质类药物的冻干封包。
Journal of parenteral science and technology : a publication of the Parenteral Drug Association Pub Date : 1992-03-01
F DeGrazio, K Flynn
{"title":"Lyophilization closures for protein based drugs.","authors":"F DeGrazio,&nbsp;K Flynn","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Rubber stopper formulations which are currently used as lyophilization stoppers vary widely in their capacities to absorb and release moisture. Release of moisture from the stopper over the shelf life of the product may result in drug degradation for extremely low cake weight products. The degree to which rubber formulations absorb water is dependent upon the components of these formulations. Independently, polymers and fillers absorb water during autoclave cycles to varying levels depending upon such factors as the solubility, structure, possibility of chemical reactions and impurity levels of these materials. Once combined into a stopper formulation, the raw materials can react to form species which further promote absorption. Data is presented comparing the absorption characteristics of low versus high absorbent rubber formulations. The release of moisture from these formulas when stoppered on vials containing dry product is also discussed.</p>","PeriodicalId":16667,"journal":{"name":"Journal of parenteral science and technology : a publication of the Parenteral Drug Association","volume":"46 2","pages":"54-61"},"PeriodicalIF":0.0,"publicationDate":"1992-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"12755469","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
The compendial, industry, and regulatory initiatives regarding aseptically processed sterile products. 药典、工业和有关无菌处理无菌产品的监管措施。
Journal of parenteral science and technology : a publication of the Parenteral Drug Association Pub Date : 1992-03-01
M S Cooper
{"title":"The compendial, industry, and regulatory initiatives regarding aseptically processed sterile products.","authors":"M S Cooper","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":16667,"journal":{"name":"Journal of parenteral science and technology : a publication of the Parenteral Drug Association","volume":"46 2","pages":"48-50"},"PeriodicalIF":0.0,"publicationDate":"1992-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"12756167","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
Toxicity potential of compounds found in parenteral solutions with rubber stoppers. 含橡胶塞的肠外溶液中化合物的潜在毒性。
Journal of parenteral science and technology : a publication of the Parenteral Drug Association Pub Date : 1992-03-01
J W Danielson
{"title":"Toxicity potential of compounds found in parenteral solutions with rubber stoppers.","authors":"J W Danielson","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Leached stopper components found in parenteral solutions produced by several manufacturers were identified and quantitated. Their toxicity potential was determined by comparing the types and quantities of the leached components with known toxicity levels and/or harmful effects. Toxicity potentials for benzaldehyde, 2-butoxyethanol, cyclohexanone, ethylbenzene, 1,1,2,2-tetrachloroethane, and tetrachloroethylene are listed. Breakdown products of dextrose (furfural and 5-hydroxymethylfurfural), which may also have harmful effects, were quantitated.</p>","PeriodicalId":16667,"journal":{"name":"Journal of parenteral science and technology : a publication of the Parenteral Drug Association","volume":"46 2","pages":"43-7"},"PeriodicalIF":0.0,"publicationDate":"1992-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"12756168","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
Dynamics of protein recovery from process filtration systems using microporous membrane filter cartridges. 使用微孔膜过滤筒的工艺过滤系统中蛋白质回收的动力学。
Journal of parenteral science and technology : a publication of the Parenteral Drug Association Pub Date : 1992-03-01
R Datar, J M Martin, R L Manteuffel
{"title":"Dynamics of protein recovery from process filtration systems using microporous membrane filter cartridges.","authors":"R Datar,&nbsp;J M Martin,&nbsp;R L Manteuffel","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The purpose of this report is to address the concern for protein concentration recovery through membrane filter cartridges at the process scale. Filtration systems consisting of pre- and/or final membrane filter cartridges were evaluated for protein concentration recovery under typical manufacturing conditions of continuous flow and high throughput volumes. Results of the study conclusively demonstrate that consideration of the protein adsorptive properties and recovery performance of cartridge filters can provide efficient bio-burden and particulate control without compromising protein yields. Understanding the dynamics of protein recovery through various prefilter and final filter cartridges can play an important role in the proper selection of a filtration system to ensure optimal life and protein yield when filtering dilute protein solutions.</p>","PeriodicalId":16667,"journal":{"name":"Journal of parenteral science and technology : a publication of the Parenteral Drug Association","volume":"46 2","pages":"35-42"},"PeriodicalIF":0.0,"publicationDate":"1992-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"12755470","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
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