EJPPS EUROPEAN JOURNAL OF PARENTERAL AND PHARMACEUTICAL SCIENCES最新文献

{"title":"Review of the efficacy of HEPA filtered air to control coronavirus risks in cleanrooms","authors":"Tim Sandle","doi":"10.37521/25203","DOIUrl":"https://doi.org/10.37521/25203","url":null,"abstract":"The risk of viral transmission in the built environment is a matter of concern in the era of the novel coronavirus pandemic, for most of society, given that humans spent the majority of their time indoors. For pharmaceuticals and healthcare, there is an additional concern about working in cleanrooms and the degree to which protective measures are appropriate. With cleanrooms, an important concern is with the efficacy of HEPA filters. This article looks at the risks stemming from SARS-CoV-2 and applies these to the cleanroom context. The article concludes that the cleanroom environment does not contribute to the risk of viral transmission, and certain design aspects can, in fact, reduce the risk compared with other built environments.\u0000\u0000Characteristics of the novel coronavirus\u0000Coronaviruses (CoV) are a large family of viruses that cause illness ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS-CoV) and SARS-CoV). Coronaviruses are zoonotic, meaning they can be transmitted between animals and people ¹. Coronaviruses are classified as RNA ‘enveloped’ viruses, whereas viruses such as rotavirus, or poliovirus are termed non-enveloped. Enveloped viruses have an envelope or outer coating which is needed by the virus to help it attach to the host cell. If this outer coating is destroyed, for example by a disinfectant, the virus cannot survive. The mode of transmission for enveloped viruses is characterized by the specific virus; however, the most common routes are via indirect or direct contact of infectious virus particles, contact with or inhalation of respiratory droplets ². \u0000\u0000The specific coronavirus of concern is SARS-CoV-2, with SARS standing for ‘severe acute respiratory syndrome’ and CoV representing ‘coronavirus’. The associated respiratory disease is termed COVID-19 (to represent ‘coronavirus disease 2019). This particular virus can cause severe respiratory disease because cells in the lung are damaged and no longer able to transport oxygen into the bloodstream. Some symptoms of disease such as fever and fatigue result from the activities of the immune system trying to eliminate the infection from the body. Heat (fever) inactivates viruses and fatigue results from the high energy demands of the immune system fighting the virus ³.","PeriodicalId":300408,"journal":{"name":"EJPPS EUROPEAN JOURNAL OF PARENTERAL AND PHARMACEUTICAL SCIENCES","volume":"52 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"122988265","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":"Barrier Technologies proposed text from PHSS Annex 1 focus group for revision of clauses/ section in version 12 of Annex 1 through the targeted consultation process.","authors":"J. Drinkwater, Di Morris","doi":"10.37521/ejpps25205","DOIUrl":"https://doi.org/10.37521/ejpps25205","url":null,"abstract":"The PHSS are one of the eleven EC appointed commenting platforms in the targeted consultation process on Annex 1, with version 12 how in the process of review and commenting. Two sections of Annex 1 are considered by the PHSS to need significantly more clarity and differentiation of technologies and approaches to qualification. This article has a focus on Barrier technologies with a follow up article and Webinars also planned for the section on Qualification of Cleanrooms and clean-air devices (that includes classification). \u0000\u0000It is considered the current section in Annex 1 version 12 does not fully differentiate Isolators and Restricted Access Barriers (RABS) and their set-up for use in sterile product manufacturing. The following is recommended replacement text (in draft) that a PHSS Annex 1 Focus group have prepared to put forward to the EC/EMA as part of overall commenting on Annex 1 version 12 that has a deadline for submission on 20 July 2020.","PeriodicalId":300408,"journal":{"name":"EJPPS EUROPEAN JOURNAL OF PARENTERAL AND PHARMACEUTICAL SCIENCES","volume":"111 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"128641563","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":"Investigation of the Transfer of Septum Microbial Contamination by Hypodermic Needles","authors":"T. Eaton, L. Ramscar, J. Cox, W. Whyte","doi":"10.37521/ejpps/2501","DOIUrl":"https://doi.org/10.37521/ejpps/2501","url":null,"abstract":"The likelihood of the transfer of microbial contamination from the surface of a vial septum into the vial liquid, by penetration of a hypodermic syringe needle, has been investigated. Experimental work was carried out with vials containing sterile microbial growth media and the use of needles of three different diameters. Three different concentrations of microbes on the surface of the vial septum (10, 100, and 1000) were used. Microbial contamination that was transferred into the growth media was determined by incubation of the vials following penetration of the septum by the needles. Contamination was detected in 87% of all the vials tested, and was generally found to increase as the concentration of septum challenge organisms and needle diameter increased.\u0000Key words: Septum seals, hypodermic needles, multi-use vials, microbial contamination","PeriodicalId":300408,"journal":{"name":"EJPPS EUROPEAN JOURNAL OF PARENTERAL AND PHARMACEUTICAL SCIENCES","volume":"35 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"132387839","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":"Pharmaceutical Cleanroom Classification using ISO 14644-1 and the EU GGMP Annex 1\u0000Part 2: Practical Application","authors":"T. Eaton","doi":"10.37521/ejpps.24402","DOIUrl":"https://doi.org/10.37521/ejpps.24402","url":null,"abstract":"Classification of cleanrooms and clean zones associated with the manufacture of medicinal products has been assessed in two articles. The first article discussed the classification requirements and principles associated with ISO 14644-1 and Annex 1 of the EU GGMP, and a suitable classification test method for aseptic manufacturing was derived. This second article considers the practical application of the method for the classification of a pharmaceutical cleanroom, and isolator located within it.\u0000\u0000Key words: Cleanroom classification, ISO 14644-1, EU GGMP Annex 1","PeriodicalId":300408,"journal":{"name":"EJPPS EUROPEAN JOURNAL OF PARENTERAL AND PHARMACEUTICAL SCIENCES","volume":"83 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"133834793","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":"Use of Hazard Analysis Critical Control Point (HACCP) methodology for biocontamination control: Assessing microbial risks and to determining environmental monitoring locations","authors":"Tim Sandle, C. Leavy, Monica Di Mattia","doi":"10.37521/ejpps.24302","DOIUrl":"https://doi.org/10.37521/ejpps.24302","url":null,"abstract":"Quality Risk Management has been an essential feature relating to the manufacture of pharmaceutical and healthcare products for several decades, and its centrality is embedded in key regulatory documents, such as Annex 1 to EU GMP where risk assessment needs to be part of the overall biocontamination control strategy. While the message for constructing pro-active risk assessment sis clear, where the industry lacks direction is with case studies. This paper presents one risk assessment tool, and one which is perhaps best suited to microbiological assessments of pharmaceutical processes and presents a case study for its application. The tool discussed is Hazard Analysis and Critical Control Points (HACCP) and the application is with assessing microbiological risks and then establishing locations for environmental monitoring. The case study is a sterility testing isolator. The paper first discusses what HACCP is and how it can be applied in general, before demonstrating how HACCP can be deployed as a robust tool for constructing or reviewing an environmental monitoring regime.","PeriodicalId":300408,"journal":{"name":"EJPPS EUROPEAN JOURNAL OF PARENTERAL AND PHARMACEUTICAL SCIENCES","volume":"203 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"121111349","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}