Installation d'une salle blanche dans l'industrie pharmaceutique PDF Download
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Author: Isabelle Germain
Publisher:
ISBN:
Category :
Languages : fr
Pages : 234
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Author: Isabelle Germain
Publisher:
ISBN:
Category :
Languages : fr
Pages : 234
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Author: Mickael Jaffar
Publisher:
ISBN:
Category :
Languages : fr
Pages : 0
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L'industrie pharmaceutique est un secteur regroupant les activités de recherche, de fabrication et de commercialisation des médicaments à usage humain et vétérinaire. Un site de production peut fabriquer des médicaments en formes sèches (comprimés, gélules, etc.), semi-solides (crème, pommade, etc.) et liquides (sirop) dont font parties les formes injectables (ampoules, seringues auto-injectables, etc.) entres autres. La fabrication d'un médicament stérile impose des exigences particulières de production visant à réduire au minimum les risques de contamination microbienne, particulaire et par des substances pyrogènes (bactérienne ou chimique). Pour maîtriser ces risques de contamination, la fabrication doit se faire obligatoirement dans une ZAC. Travailler dans une salle propre consiste en une maîtrise de la contamination du milieu, matériel, mains d'œuvre, matières premières et méthodes tout au long du cycle de production d'un médicament. La conception, le nettoyage et la désinfection sont des critères permettant l'obtention d'une salle propre (BPF 2015, LD1 et glossaire). On peut également parler de zone propre, qui selon la norme ISO 14644 se définit comme un «espace dédié dans lequel la concentration des particules en suspension dans l'air est maîtrisée et qui est construit et utilisé de façon à minimiser l'introduction, la production et la rétention de particules à l'intérieur de la pièce, et dans laquelle d'autres paramètres pertinents, tels que la température, l'humidité et la pression sont maîtrisés comme il convient». Le terme de zone propre englobe donc d'autres caractéristiques par rapport aux ZAC. Un moyen d'optimisation de la désinfection est la mise en place d'un procédé de décontamination par voie aérienne. Ces procédés sont encadrés par un contexte réglementaire, dans le respect des règles HSE. Les industries pharmaceutiques ont le choix entre deux procédés de décontamination, l'un utilisant le peroxyde d'hydrogène seul et l'autre en association avec l'acide peracétique.
Author: LAURENT.. VINCENS
Publisher:
ISBN:
Category :
Languages : fr
Pages :
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Author: Lucie Chassé
Publisher:
ISBN:
Category :
Languages : fr
Pages : 148
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Author: Sophie Merciari
Publisher:
ISBN:
Category :
Languages : fr
Pages : 344
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Author: International Institute of Refrigeration
Publisher:
ISBN:
Category : Refrigeration and refrigerating machinery
Languages : fr
Pages : 888
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Book Description
Some numbers called Special issue and consist of summaries of papers to be presented at the International Congresses of Refrigeration.
Author: IARC Working Group on the Evaluation of Carcinogenic Risks to Humans
Publisher: World Health Organization
ISBN:
Category : Health & Fitness
Languages : en
Pages : 536
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Evaluates the carcinogenic risks to humans posed by the use of four antiretroviral agents four DNA topoisomerase II inhibitors used in the treatment of cancer and an additional three pharmaceutical agents (hydroxyures phenolphthalein and vitamin K substances). The volume marks the first IARC evaluation of nucleoside analogs that act as antiviral agents. The evaluation responds in part to recent findings that zidovudine (AZT) an effective antiretroviral agent now being given to pregnant HIV-infected women to prevent maternal-to-fetal transmission of the virus is a transplacental carcinogen in mice. The opening monograph evaluates the carcinogenicity to humans of the antiretroviral nucleoside analogs zidovudine (AZT) zalcitabine (ddC) and didanosine (ddI) and the antiherpesvirus drug aciclovir. Of these aciclovir and didanosine could not be classified on the basis of available data. For zidovudine transplacental administration to mice resulted in an increased incidence and multiplicity of lung and liver tumours and in an increased incidence of female reproductive tract tumours in one study but not in another involving treatment at a lower dose. Despite observation of toxic effects in some studies of humans human carcinogenicity data were judged to provide inadequate evidence of carcinogenicity in humans. Zidovudine was classified as possibly carcinogenic to humans. Similar weaknesses in human carcinogenicity data for zalcitabine which consistently induces thymic lymphomas in mice resulted in its classification as possibly carcinogenic to humans. The second monograph evaluates four DNA topoisomerase II inhibitors: etoposide teniposide mitoxantrone and amsacrine. Of these etoposide - one of the most widely used and effective cytotoxic drugs in combination therapy - was classified as probably carcinogenic to humans and etoposide in combination with cisplatin and bleomycin was judged to be carcinogenic to humans. Teniposide was classified as probably carcinogenic to humans and mitoxantrone and amsacrine were classified as possibly carcinogenic to humans. Of the three pharmaceutical agents evaluated in the final monograph hydroxyurea which is widely used in cancer treatment and increasingly in combination with didanosine in HIV infection could not be classified. Phenolphthalein a widely used laxative now being withdrawn from the market in many countries because of toxicological concerns was classified as possibly carcinogenic. Vitamin K substances could not be classified on the basis of available evidence.
Author:
Publisher: Odile Jacob
ISBN: 2738196551
Category :
Languages : en
Pages : 385
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Author: Robin Pogrebin
Publisher: Penguin
ISBN: 0593084403
Category : Biography & Autobiography
Languages : en
Pages : 336
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Book Description
"A remarkable work of slowed-down journalism...They are doing their jobs as journalists and writing the first draft of history." —Jill Filipovic, The Washington Post "...Generous but also damning." —Hanna Rosin, The New York Times From two New York Times reporters, a deeper look at the formative years of Supreme Court Justice Brett Kavanaugh and his confirmation. In September 2018, the F.B.I. was given only a week to investigate allegations of sexual misconduct against Brett Kavanaugh, President Trump's Supreme Court nominee. But even as Kavanaugh was sworn in to his lifetime position, many questions remained unanswered, leaving millions of Americans unsettled. During the Senate confirmation hearings that preceded the bureau's brief probe, New York Times reporters Robin Pogrebin and Kate Kelly broke critical stories about Kavanaugh's past, including the "Renate Alumni" yearbook story. They were inundated with tips from former classmates, friends, and associates that couldn't be fully investigated before the confirmation process closed. Now, their book fills in the blanks and explores the essential question: Who is Brett Kavanaugh? The Education of Brett Kavanaugh paints a picture of the prep-school and Ivy-League worlds that formed our newest Supreme Court Justice. By offering commentary from key players from his confirmation process who haven't yet spoken publicly and pursuing lines of inquiry that were left hanging, it will be essential reading for anyone who wants to understand our political system and Kavanaugh's unexpectedly emblematic role in it.
Author: Sven Boermeester
Publisher:
ISBN: 9781949677072
Category :
Languages : en
Pages :
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Book Description
Innovate Bristol highlights and celebrates those companies and individuals that are actively working at building a better tomorrow for all. Innovation Ecosystems thrive through the involvement and support of companies and individuals from all industries, which is why the Innovate series not only focuses on the innovators but also those people whom the Innovation Ecosystem, would not be able to thrive without.
