EJPPS EUROPEAN JOURNAL OF PARENTERAL AND PHARMACEUTICAL SCIENCES最新文献

{"title":"Anaerobes and the cleanroom operator association: Is there a case for anaerobic environmental monitoring?","authors":"Tim Sandle","doi":"10.37521/ejpps.27303","DOIUrl":"https://doi.org/10.37521/ejpps.27303","url":null,"abstract":"Is anaerobic environmental monitoring necessary? For obligate anaerobes the case for doing so is low. For facultative anaerobes, where aseptically filled parenteral products are involved, the case is far higher. Any such consideration should be based on a quality risk assessment taking into account the interactions between people and exposed product or product components and the opportunity for particle deposition. In many cases, the risk will not be known unless selective environmental monitoring has been performed given the slow growth rate of organisms like Cutibacterium acnes and the preferential growth obtained using an anaerobic atmosphere and a blood-based culture medium. The argument of this paper is not so much with whether anaerobic monitoring is necessary for aseptically filled products, but with how often should this be performed?","PeriodicalId":300408,"journal":{"name":"EJPPS EUROPEAN JOURNAL OF PARENTERAL AND PHARMACEUTICAL SCIENCES","volume":"11 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"122424972","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":"LAL Non-Endotoxin Reactivity - Surprisingly Non-specific","authors":"K. Williams","doi":"10.37521/ejpps.27302","DOIUrl":"https://doi.org/10.37521/ejpps.27302","url":null,"abstract":"Nature abounds in producing a variety of molecules. This is a good thing, however, in endotoxin detection a requirement for an analytical assay is “specificity”. Unfortunately, LAL has been found to be increasingly non-specific since the inception of its use in lieu of the rabbit pyrogen test. Fortunately, there are viable workarounds in terms of using Limulus-based testing where non-endotoxin reactive substance false-reactivity is problematic.\u0000\u0000\u0000In analytical testing, just as in metazoan immune detection of potential microbial invaders, context is everything. The horseshoe crab from which LAL is derived swims and crawls on a beach interface that teems with Gram Negative bacteria (GNB), estimated by some at over 10⁶ CFUs/mL. In this context, the extreme sensitivity of Limulus hemolymph to GNB evolved over the eons. However, it also evolved to detect many other substances relevant to the sea/shore paradigm. This includes especially glucans from fungi and algae/lichens (also widely found in terrestrial plants) and also cellulose and mannans as microbial sugars.","PeriodicalId":300408,"journal":{"name":"EJPPS EUROPEAN JOURNAL OF PARENTERAL AND PHARMACEUTICAL SCIENCES","volume":"83 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"124851535","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":"Identification of Bacterial Isolates Recovered from the Surface of Cleanroom Operators’ Garments following Wear","authors":"Laurie M. Smith, Christina Lowes, Noëlle H. O’ Driscoll, A. J. Lamb","doi":"10.37521/ejpps.27301","DOIUrl":"https://doi.org/10.37521/ejpps.27301","url":null,"abstract":"Background\u0000Contamination of sterile pharmaceutical products can have serious consequences, in worst case scenario resulting in patient death. Cleanroom operators are the primary source of microbial contamination, where the surface of their specialist sterile clothing garments is subject to such contamination during wear. In turn these garments become a transmission vector for microorganisms within the cleanroom environment. Insight into identification of predominant bacterial isolates from garment surfaces would help to establish their original source and probable contamination route. This should assist possible intervention strategies to mitigate against this contamination. \u0000\u0000Aim\u0000The research aimed to determine identity of representative bacterial isolates recovered from the surface of cleanroom operators’ garments following wear within a cleanroom. \u0000\u0000Methods\u0000Following isolation and purification of bacterial isolates, 16S rRNA gene sequencing was used to establish species identity for isolates recovered from the surface of male and female operators’ garments following wear within the cleanroom environment. \u0000\u0000Results \u0000Of the 47 isolates recovered from the surface of garments, 16S rRNA gene sequencing successfully identified 94 % to genus level and 77 % to species level. Most were confirmed as Gram - positive bacteria; predominantly species of Staphylococcus, Micrococcus and Bacillus. The isolates recovered from the surface of female operatives’ garments were more diverse than those retrieved from male counterparts. \u0000\u0000Conclusion\u0000Most isolates recovered from garments were found to be skin commensals, with nearly 70% attributed to the operators within the environment. The remainder were credited to contamination of garments with species of environmental origin. Whilst most bacteria identified present minimal threat to healthy individuals, certain of these are opportunistic pathogens, presenting a hazard for immunocompromised and/or those with underlying health conditions.","PeriodicalId":300408,"journal":{"name":"EJPPS EUROPEAN JOURNAL OF PARENTERAL AND PHARMACEUTICAL SCIENCES","volume":"195 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"133399593","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":"Examination of the growth rates of environmental isolates compared with compendial strains","authors":"Tim Sandle","doi":"10.37521/ejpps.27201","DOIUrl":"https://doi.org/10.37521/ejpps.27201","url":null,"abstract":"For some years there has been a regulatory drive for microbiology laboratories to use environmental isolates for media quality control and for the incorporation into method suitability studies. Where these organisms are included in testing regimes, do they take longer to grow? This paper assesses the growth rates of environmental isolates in comparison with compendial recommended cultures. The research presented here finds that environmental isolates do take slightly longer to grow compared with laboratory strains, yet this time difference was within the recommended incubation times of each test type. Therefore, microbiologists should generally expect slower growth but test methods may not need to be adapted to compensate.","PeriodicalId":300408,"journal":{"name":"EJPPS EUROPEAN JOURNAL OF PARENTERAL AND PHARMACEUTICAL SCIENCES","volume":"8 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"126948844","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":"Application of Quality by Design Approach in Development of Cefixime Trihydrate Loaded Gastro-retent","authors":"Ankit Mishra, Priyanka Chaturvedi, S. K. Paswan","doi":"10.37521/ejpps.27202","DOIUrl":"https://doi.org/10.37521/ejpps.27202","url":null,"abstract":"Cefixime is an antibiotic that belongs to the 3rd generation cephalosporin antibacterial and acts by interrupting the cell wall synthesis of bacteria. It is a weakly acidic drug primarily absorbed through the stomach and upper intestine as a unionized drug. The drug is incompletely absorbed from GIT, leading to poor bioavailability. The current research focuses on developing gastro-retentive mucoadhesive microspheres loaded with cefixime trihydrate. The drug remains in the unionized form in acidic pH, showing enhanced absorption through the stomach. Mucoadhesive microspheres of cefixime trihydrate were prepared using HPMC K15M and Carbopol 971P as carrier polymer and mucoadhesive polymer, respectively. The formulation was prepared by using the spray drying technique.\u0000\u0000Further, the in-vitro evaluation of the mucoadhesive property of cefixime microspheres was done on the goat stomach mucosa. The study showed a strong mucoadhesion of 82% for an extended period of gastroprotection up to 6 hours. The in-vitro drug release study of microspheres was performed using 0.1 N HCl. The prepared formulation exhibited extended release for up to 8 hours. It is concluded from the above studies that the current formulation has been elicited prolonged gastric residence time as well as extended-release and provided an opportunity for better and enhanced absorption of the drug. Thus, the formulation may be projected for better therapeutic value, probably by improving the bioavailability of the experimental drugs.","PeriodicalId":300408,"journal":{"name":"EJPPS EUROPEAN JOURNAL OF PARENTERAL AND PHARMACEUTICAL SCIENCES","volume":"161 7 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"129088267","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":"A review on analytical methods of cilnidipine and its combinations","authors":"Pranali Mishra, Ankit Mishra, Parul Mehta","doi":"10.37521/ejpps.271011","DOIUrl":"https://doi.org/10.37521/ejpps.271011","url":null,"abstract":"Background - The chase to improve the quality of life has stimulated desirable changes in research to design and develop a new drug and enhance its safety and effectiveness. Thus, there is a gradual rise in demand to develop susceptible and specific analytical techniques for newly developed drugs. Thus, analysts are striving very hard to develop new and efficient analytical methods to achieve these targets. \u0000\u0000\u0000Main body of abstract - Analytical methods that analyze drug compounds in a given matrix need to be optimized and validated to ensure excellent selectivity, sensitivity, ease of use, speed of analysis, less expensive, and efficient analytical procedures. Developing a new analytical method should be considered critical, based on availability and accurate handling of different instruments. This review is a genuine venture of compiled literature of earlier and recent trends in the method developments for Cilnidipine (CLD) analysis alone and in combination with other drugs. It provides an in-depth assortment of practical aspects of various analytical techniques published for CLD. \u0000\u0000\u0000Conclusion - High-performance liquid chromatography and ultraviolet spectroscopy have been found the most acceptable for the analysis of CLD. Stability indicating studies and impurity profiling of CLD also prevailed in the assembled literature. Scanty work was observed with capillary electrophoresis, Fourier transform-infrared spectroscopy, and electroanalytical methods to analyze CLD. Applications mentioned for CLD are significant in their particular field and contribute to analytical assay in future endeavours. \u0000\u0000Keywords- Cilnidipine, Bioanalytical method, Stability indicating method, HPLC, Spectrophotometry.","PeriodicalId":300408,"journal":{"name":"EJPPS EUROPEAN JOURNAL OF PARENTERAL AND PHARMACEUTICAL SCIENCES","volume":"31 11 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-03-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"123799394","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":"Walk on the wild side: The application of environmental isolates in microbiological testing","authors":"Tim Sandle","doi":"10.37521/ejpps.27104","DOIUrl":"https://doi.org/10.37521/ejpps.27104","url":null,"abstract":"Environmental isolates are commonly used in the pharmaceutical sector to challenge microbial test methods and to release culture media. Does the use of these organisms add value? There are arguments in favour of this practice (broadening the test panel and with the assumption that some ‘wildtype’ characteristics are retained) and against (such as environmental isolates being difficult to standardise and the expectation that ‘wildtype’ characteristics are lost at some time point or they are not retained at all with the first subculture onto laboratory media). This paper considers these arguments.","PeriodicalId":300408,"journal":{"name":"EJPPS EUROPEAN JOURNAL OF PARENTERAL AND PHARMACEUTICAL SCIENCES","volume":"15 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"121636230","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":"Recovery of Microbial Contamination with Settle Plates Exposed in a Unidirectional Airflow Workstation for 4 Hours","authors":"T. Eaton, Karen Capper, A. Nash, S. Drinkwater, J. Bright","doi":"10.37521/ejpps.27103","DOIUrl":"https://doi.org/10.37521/ejpps.27103","url":null,"abstract":"The ability of irradiated 90 mm diameter Tryptone Soya Agar (TSA) settle plates, exposed for 4 hours in a unidirectional airflow (UDAF) workstation (air supply velocity 0.45 m/s), to recover microbial contamination, was investigated. The investigation was completed by inoculation of numerous test plates with a range of different test micro-organisms and then exposure of the plates within a UDAF workstation for 4 hours. Following incubation, the numbers of recovered micro-organisms were compared with the numbers recovered from control plates that had been identically inoculated and incubated but not exposed within the workstation. Investigations of initial settle plate weight variation, loss of weight and water activity levels during exposure were also completed to help understand the influence of plate media water to any loss of microbial recovery. It was determined that the average number of recovered test plate colonies was reduced compared to the control plates and the exposure of the plates reduced the weight by an average of 10.85%. However, the media water activity levels remained consistently higher than the threshold level at which the growth of micro-organisms would be affected and the ability of the plates to recover micro-organisms was reduced but not significantly affected. \u0000\u0000 \u0000\u0000Key words: Microbiological settle plates, media dehydration, unidirectional airflow (UDAF), 4 hour exposure","PeriodicalId":300408,"journal":{"name":"EJPPS EUROPEAN JOURNAL OF PARENTERAL AND PHARMACEUTICAL SCIENCES","volume":"9 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"125986440","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":"Formal methods of selecting monitoring locations and control levels","authors":"W. Whyte","doi":"10.37521/ejpps.27102","DOIUrl":"https://doi.org/10.37521/ejpps.27102","url":null,"abstract":"It is necessary to determine locations in a cleanroom where airborne concentrations of particles and microbe-carrying particles (MCPs) should be monitored. It is also necessary to determine the concentrations of airborne contamination that should not be exceeded during manufacturing operations, ie. the alert and action control levels. Both these requirements can be ascertained by simple and informal means. However, should a formal approach be required, the monitoring locations can be determined by a risk assessment, and the control levels by a statistical method. \u0000\u0000\u0000Key Words: Monitoring, airborne particles, control levels, pharmaceutical, cleanrooms","PeriodicalId":300408,"journal":{"name":"EJPPS EUROPEAN JOURNAL OF PARENTERAL AND PHARMACEUTICAL SCIENCES","volume":"18 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"114405523","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":"End-to-end qualification of ready-to-use (RTU) product containers in packaging suitable for No-Touch Transfer (NTT) into Grade A filling zones","authors":"Holger Kranenburg, Birte Scharf, P. Wolf, R. Lindner","doi":"10.37521/ejpps.26401","DOIUrl":"https://doi.org/10.37521/ejpps.26401","url":null,"abstract":"No-Touch Transfer (NTT) of pre-sterilised ready-to-use (RTU) containers is an alternative methodology that follows Good Manufacturing Practice (GMP) and Quality Risk Management (QRM) principles. NTT de-bagging ejects contents from secondary bag packaging without direct contact with contents or exposure to an environment that is a lower grade than the zone being entered. The pre-sterilised containers and sterile barriers offer assured sterility at manufacture and are qualified to remain sterile through the supply chain and the stepwise NTT de-bagging process. This eliminates the requirement for in-process material disinfection steps for transfer into Grade A environments. \u0000\u0000The present article focuses on design qualification of pre-sterilised RTU container packaging, including definition of sterile barriers together with bioburden study data through the supply chain and simulated NTT. It completes a series of EJPPS articles to support peer-reviewed references on NTT. Together, these articles can be defined as end-to-end qualification of the NTT process, demonstrating a high level of assurance that sterility is maintained from manufacture to point of use.\u0000\u0000Key Words: Aseptic processing, Design qualification, Good Manufacturing Practice (GMP), Life cycle, No-Touch Transfer (NTT), Pharmaceutical packaging, Pre-sterilised containers, Qualification, Quality by Design (QbD), Quality Risk Management (QRM), Ready-to-use (RTU), Supply chain","PeriodicalId":300408,"journal":{"name":"EJPPS EUROPEAN JOURNAL OF PARENTERAL AND PHARMACEUTICAL SCIENCES","volume":"23 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"125591161","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}