{"title":"Guideline on control of computerized systems in drug manufacturing. Parenteral Drug Association.","authors":"T Matsuda","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":79406,"journal":{"name":"Journal of pharmaceutical science and technology : the official journal of PDA","volume":"48 1","pages":"11-5"},"PeriodicalIF":0.0,"publicationDate":"1994-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"18999282","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}
When monitoring the microbiological quality of air in unidirectional air flow units the Biotest air sampler Reuter Centrifugal Sampler (RCS) is often used. In this unidirectional air flow the dispersion region of contaminants (disturbance region caused by turbulence) around the RCS sampler is much larger than that of undisturbed parallel air flow. The recently developed air sampler from Biotest, the RCS+, has a smaller and a different type of dispersion region (disturbance region) than that of the common RCS sampler. The differences must be taken into consideration when the two types of RCS air sampler are used within unidirectional air flow units, especially during aseptic operations in pharmaceutical production.
{"title":"The biotest RCS air samplers in unidirectional flow.","authors":"B Ljungqvist, B Reinmüller","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>When monitoring the microbiological quality of air in unidirectional air flow units the Biotest air sampler Reuter Centrifugal Sampler (RCS) is often used. In this unidirectional air flow the dispersion region of contaminants (disturbance region caused by turbulence) around the RCS sampler is much larger than that of undisturbed parallel air flow. The recently developed air sampler from Biotest, the RCS+, has a smaller and a different type of dispersion region (disturbance region) than that of the common RCS sampler. The differences must be taken into consideration when the two types of RCS air sampler are used within unidirectional air flow units, especially during aseptic operations in pharmaceutical production.</p>","PeriodicalId":79406,"journal":{"name":"Journal of pharmaceutical science and technology : the official journal of PDA","volume":"48 1","pages":"41-4"},"PeriodicalIF":0.0,"publicationDate":"1994-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"18999290","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}
The author raises questions not usually considered in discussions of validation: "How much validation can the world afford?," "Are we getting value for money?," and "What's in it for the patient?." The paper develops the theme that, while validation is undoubtedly important, the pharmaceutical industry has not given adequate thought as to whether the benefits of validation outweigh the costs in implementation of validation.
{"title":"Validation--how much can the world afford? Are we getting value for money?","authors":"M H Anisfeld","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The author raises questions not usually considered in discussions of validation: \"How much validation can the world afford?,\" \"Are we getting value for money?,\" and \"What's in it for the patient?.\" The paper develops the theme that, while validation is undoubtedly important, the pharmaceutical industry has not given adequate thought as to whether the benefits of validation outweigh the costs in implementation of validation.</p>","PeriodicalId":79406,"journal":{"name":"Journal of pharmaceutical science and technology : the official journal of PDA","volume":"48 1","pages":"45-8"},"PeriodicalIF":0.0,"publicationDate":"1994-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"18999291","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}
Reduced glutathione was found to guard against photodecomposition (under fluorescent light) of the anticancer drug dacarbazine (DTIC). Increase in pH appeared to accelerate the degradation of DTIC within a pH range of 4.5-8.1. The stabilizing effect of reduced glutathione was found to increase with its concentration reaching an optimum value at 5 mg%. Increase of ionic strength slightly enhanced the photostability of DTIC solutions in pH 7 phosphate buffer (0.05 M). Different buffer systems at pH 4.5 did not significantly alter the degradation rate of the drug in the absence of reduced glutathione. However, in presence of reduced glutathione, dacarbazine appeared to be less stable in acetate buffer of pH 4.5.
{"title":"Photostabilization of dacarbazine with reduced glutathione.","authors":"M S Islam, A F Asker","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Reduced glutathione was found to guard against photodecomposition (under fluorescent light) of the anticancer drug dacarbazine (DTIC). Increase in pH appeared to accelerate the degradation of DTIC within a pH range of 4.5-8.1. The stabilizing effect of reduced glutathione was found to increase with its concentration reaching an optimum value at 5 mg%. Increase of ionic strength slightly enhanced the photostability of DTIC solutions in pH 7 phosphate buffer (0.05 M). Different buffer systems at pH 4.5 did not significantly alter the degradation rate of the drug in the absence of reduced glutathione. However, in presence of reduced glutathione, dacarbazine appeared to be less stable in acetate buffer of pH 4.5.</p>","PeriodicalId":79406,"journal":{"name":"Journal of pharmaceutical science and technology : the official journal of PDA","volume":"48 1","pages":"38-9"},"PeriodicalIF":0.0,"publicationDate":"1994-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"18999286","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}
{"title":"IV fluid makers: preparation of sterile water for injection in a field setting.","authors":"J C Bray","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":79406,"journal":{"name":"Journal of pharmaceutical science and technology : the official journal of PDA","volume":"48 1","pages":"2"},"PeriodicalIF":0.0,"publicationDate":"1994-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"18999284","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}
{"title":"PDA presentation at FDA Open Conference on Sterile Drug Manufacturing. Parenteral Drug Association.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":79406,"journal":{"name":"Journal of pharmaceutical science and technology : the official journal of PDA","volume":"48 1","pages":"4-6"},"PeriodicalIF":0.0,"publicationDate":"1994-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"18999287","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}
Dry heat resistance parameters for Neosartorya fischeri ascospores were obtained at 90 degrees C and 95 degrees C under 30%, 40%, 50%, 60%, and 75% relative humidity (RH) conditions. The dry heat treated spores were exposed to saturated water vapor (for 20-24 h at 4 degrees C) prior to recovery in buffer held at two temperatures (0 degrees C and 80 degrees C). Approximately the same level of recovery was obtained at the two buffer temperatures except at the shortest heating times for the heat treatment carried at 30% and 40% RH, where the number of survivors was significantly higher for spores placed in the buffer held at 80 degrees C. The effect of this high temperature was attributed to heat activation of the ascospores that remained dormant during the dry heat treatment conditions mentioned above. The wet heat resistance of N. fischeri ascospores was also determined at temperatures ranging from 82.5 degrees C to 95 degrees C. The results indicate that as the RH decreased, the heat resistance of the ascospores increased. There were about four orders of magnitude difference in the heat resistance between wet heat (100% RH) and the lowest dry heat treatment condition (30% RH).
{"title":"Resistance of Neosartorya fischeri to wet and dry heat.","authors":"M M Gómez, I J Pflug, F F Busta","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Dry heat resistance parameters for Neosartorya fischeri ascospores were obtained at 90 degrees C and 95 degrees C under 30%, 40%, 50%, 60%, and 75% relative humidity (RH) conditions. The dry heat treated spores were exposed to saturated water vapor (for 20-24 h at 4 degrees C) prior to recovery in buffer held at two temperatures (0 degrees C and 80 degrees C). Approximately the same level of recovery was obtained at the two buffer temperatures except at the shortest heating times for the heat treatment carried at 30% and 40% RH, where the number of survivors was significantly higher for spores placed in the buffer held at 80 degrees C. The effect of this high temperature was attributed to heat activation of the ascospores that remained dormant during the dry heat treatment conditions mentioned above. The wet heat resistance of N. fischeri ascospores was also determined at temperatures ranging from 82.5 degrees C to 95 degrees C. The results indicate that as the RH decreased, the heat resistance of the ascospores increased. There were about four orders of magnitude difference in the heat resistance between wet heat (100% RH) and the lowest dry heat treatment condition (30% RH).</p>","PeriodicalId":79406,"journal":{"name":"Journal of pharmaceutical science and technology : the official journal of PDA","volume":"48 1","pages":"16-23"},"PeriodicalIF":0.0,"publicationDate":"1994-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"18999283","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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