EJPPS EUROPEAN JOURNAL OF PARENTERAL AND PHARMACEUTICAL SCIENCES最新文献

{"title":"Performance of Cleanroom Garment Fabrics When Processed in an Industrial Laundry, Comparing Irradiation and Autoclave Sterilisation","authors":"Kieran Broadbridge, Davey A. Stoker, Greg Cochran, G. Kuzma","doi":"10.37521/ejpps.26402","DOIUrl":"https://doi.org/10.37521/ejpps.26402","url":null,"abstract":"EU GMP Annex 1 requires that “reusable garments should be replaced based at a set frequency determined by qualification, or if damage is identified.” [1]\u0000\u0000In the UK, most cleanroom garments supplied to the pharmaceutical and healthcare sectors are washed and sterilised by gamma irradiation.\u0000\u0000This study compares cleanroom garment fabric performance across the lifespan of multiple fabrics. Previous research has shown that cleanroom garment fabrics terminally sterilised by gamma irradiation remain suitable for use for up to 50 processes, however, these studies often focus on a limited number of samples. This study uses a large sample set, analysing the performance up to 100 processes and compares the performance effects of gamma irradiation vs autoclaving, as an alternative sterilisation method.\u0000\u0000Multiple market leading cleanroom garment fabrics were washed and dried using a standard industrial cleanroom laundry process and sterilised by either gamma irradiation or autoclave. They were tested for particle barrier efficiency, abrasion resistance, pore size, and tensile strength as new, then at set process counts throughout their life, 10, 20, 30, 50, 70 and 100 processes. A process is equal to one wash/dry/sterilisation cycle.\u0000\u0000The results show that not all cleanroom garment fabrics deteriorate equally and that some market leading fabrics may not provide adequate performance throughout life, even if they are suitable when new. They also show that autoclaving is comparable with irradiation in durability and performance over a fabric’s life, in some cases performing better than irradiation above process counts of 50.","PeriodicalId":300408,"journal":{"name":"EJPPS EUROPEAN JOURNAL OF PARENTERAL AND PHARMACEUTICAL SCIENCES","volume":"26 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":"124019863","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 Comparison of the Bacterial Contamination of the Surface of Cleanroom Operators’ Garments following Donning with and without Gloves","authors":"Laurie M. Smith, Noëlle H. O’ Driscoll, A. J. Lamb","doi":"10.37521/ejpps.26302","DOIUrl":"https://doi.org/10.37521/ejpps.26302","url":null,"abstract":"Background\u0000Specialist cleanroom garments are a potential vector for transmission of microorganisms within these facilities. In order to maintain the low bioburden of such clothing it has been perceived best practice for operators to dress wearing sterile cleanroom gloves. However, the efficacy of such glove use upon the resultant bacterial contamination of the surface of cleanroom garments has not previously been evaluated. \u0000\u0000Aim\u0000To compare surface bacterial contamination of cleanroom garments following their donning by operators dressing with or without gloves.\u0000\u0000Methods\u0000Following prior handwashing and systematic donning of cleanroom clothing by operators dressing wearing either no gloves, non-sterile nitrile gloves or sterile cleanroom latex gloves, a direct agar contact method was immediately undertaken to test garment surfaces at 7 specific sites. Following incubation bacterial levels were suitably quantified. \u0000\u0000Findings\u0000Comparing levels of growth displayed on plates used to test the surface of cleanroom garments worn by operators dressing with no gloves, non–sterile gloves or sterile cleanroom gloves, no significant difference was observed between the percentage of contact plates displaying growth and the levels of growth observed on plates, from any of the sites tested.\u0000\u0000Conclusion\u0000Omission of gloves in line with a systematic handwashing procedure prior to the cleanroom garment donning process, may result in modest economic and environmental gain coupled with a slightly less burdensome procedure. However, this is reliant on rigorous adherence to handwashing protocol and assessment of associated risk factors.","PeriodicalId":300408,"journal":{"name":"EJPPS EUROPEAN JOURNAL OF PARENTERAL AND PHARMACEUTICAL SCIENCES","volume":"2 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-10-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"132459071","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":"Microbial Air Samplers for Meaningful Cleanroom Environmental Monitoring","authors":"T. Eaton","doi":"10.37521/ejpps.26301","DOIUrl":"https://doi.org/10.37521/ejpps.26301","url":null,"abstract":"Airborne microbiological concentrations within pharmaceutical cleanrooms are determined by sampling and to maximise the detection of any airborne microbes, it is essential that the sampling is undertaken in locations where there is greatest contamination risk using air samplers that have a verified and appropriate performance. Sampler performance can be assessed by review of both the physical and biological collection efficiencies that are determined by testing. The physical collection efficiency is the ability to collect particles of various sizes and the biological collection efficiency assesses the collection of viable microbes that includes the losses caused by the physical collection efficiency and the detrimental effect that the sampling has on the viability of the captured microbes. Due to the limitations of the established biological collection efficiency test method, this efficiency is only determined for microbes of sub-micron size which are not representative of the larger microbe-carrying particles typically present with cleanrooms. \u0000\u0000Samplers with a low physical collection efficiency for sub-micron particles are likely to have a poor performance when this test method is utilised and in an attempt to remove this bias from the testing the ‘biological efficiency’, is often reported. This is a measure of the likelihood that any captured microbes would survive, but is often mistaken for the biological collection efficiency and samplers may be utilised in the false belief that they have an appropriate performance. This article provides information regarding air sampler performance testing and reviews the test results reported by the same independent specialist testing company, therefore negating issues resulting from different testing methods, for three different air samplers. The results that are used to determine the ‘biological efficiency’ are examined to provide information relating to the biological collection efficiency of each sampler and to also provide additional information relating to the physical collection efficiency. Improvements to enhance the air sampler testing procedures, to enable a better direct comparison of the performance of different samplers, are suggested.","PeriodicalId":300408,"journal":{"name":"EJPPS EUROPEAN JOURNAL OF PARENTERAL AND PHARMACEUTICAL SCIENCES","volume":"120 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-10-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"124037114","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":"Recommendations of scientifically sound and appropriate sampling plans for parenteral drug products","authors":"Ian Aled Jones, Alex Bird, Nathaniel Lochrie","doi":"10.37521/ejpps.26303","DOIUrl":"https://doi.org/10.37521/ejpps.26303","url":null,"abstract":"This paper gives recommendations for defining sampling plans/sizes that are statistically justified or based on published guidance for typical parenteral drug products\u0000\u0000\u0000 Simple tables based on the ANSI/ASQ Z1.4 acceptance sample plans or other published guidance have been collated to aid organisations in selection of appropriate sample sizes/plans for routine drug product manufacture.\u0000\u0000\u0000Key Words: USP <1790>, visual inspection, AQL, power, sample size","PeriodicalId":300408,"journal":{"name":"EJPPS EUROPEAN JOURNAL OF PARENTERAL AND PHARMACEUTICAL SCIENCES","volume":"4 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-10-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"125635036","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":"Comparative Evaluation of Amorphous Polymers in Solubility and Bioavailability Enhancement of Famotidine Through Solid Dispersion","authors":"Ankit Mishra, Priyanka Chaturvedi, Pranali Mishra, M. Sudheesh","doi":"10.37521/ejpps.26201","DOIUrl":"https://doi.org/10.37521/ejpps.26201","url":null,"abstract":"The present study aimed to enhance the dissolution rate, therefore bioavailability, of famotidine (FMT) using its solid dispersions (SDs) with polyvinyl pyrrolidone (PVP)-K 30, milk powder, and inulin, both in-vitro and in-vivo. The study was also aimed to compare the effect of different amorphous polymers in enhancing the dissolution rate of FMT. The SDs were prepared with a 1:4 weight ratio by a solvent evaporation technique. Evaluation of the properties of the SDs was performed using dissolution, Fourier-transform infrared (FTIR) spectroscopy, and X-ray diffraction (XRD) studies. The SDs of FMT exhibited an enhanced dissolution rate. The FTIR spectroscopic studies showed the stability of FMT and the absence of well-defined drug excipient interaction. The XRD studies indicated the amorphous state of FMT in SDs. The drug release rate of all SDs formulation was found to be greater than the pure drug. Within one hour of dissolution studies, 99.43%, 92.5%, and 58.93% drug release were obtained, respectively, for PVP K-30, milk powder, and inulin. The first two were showing significantly higher release. SDs were also studied for bioavailability studies in-vivo in rats, which confirms that the SDs prepared by PVP K-30 and milk powder significantly enhancing the bioavailability of FMT. The maximum concentration of 15.05±2.45 μg/ml was achieved in 2 hours, and the area under the curve was found to be 33.78±7.3 μg. hour/ml. Therefore, the study results conclude that SDs of the FMT prepared by PVP K-30 successfully increases the dissolution and in-vivo bioavailability.\u0000\u0000\u0000Keywords – Solid dispersion, Second generation solid dispersions, Famotidine, In-vivo bioavailability, amorphous polymers, dissolution enhancement, solubility enhancement.","PeriodicalId":300408,"journal":{"name":"EJPPS EUROPEAN JOURNAL OF PARENTERAL AND PHARMACEUTICAL SCIENCES","volume":"17 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-07-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"127395029","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 global disinfectant standard for cleanrooms: Presenting a harmonised approach","authors":"Tim Sandle","doi":"10.37521/EJPPS26101","DOIUrl":"https://doi.org/10.37521/EJPPS26101","url":null,"abstract":"Disinfectant efficacy testing is an essential part of a facility contamination control strategy. Pharmaceutical and healthcare products facilities must know that the products they are using can achieve effective levels of microbial kill across a range of surface types. \u0000\u0000The problem faced by microbiologists and production managers is that the various national and international standards use different methodologies. In addition, these standards and methods have not been written specifically for cleanrooms and the microbial test panels and logarithmic reduction expectations are not considered suitable.\u0000\u0000In order to develop an international standard suitable for all pharmaceutical facility cleanrooms, Ecolab has developed the Validex™ method, which is independently assessed in this paper. This method involves using 2 cm diameter disks, to target a 3 log reduction for vegetative bacteria in 5 minutes; and a 2 log reduction for fungi and bacterial spores in 10 minutes. The key criteria and rationale for selection, along with the methodology, are presented in this paper.","PeriodicalId":300408,"journal":{"name":"EJPPS EUROPEAN JOURNAL OF PARENTERAL AND PHARMACEUTICAL SCIENCES","volume":"20 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-04-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"125292434","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":"Effective Reusable Cleanroom Garments and Evaluation of Garment Life","authors":"T. Eaton, W. Whyte","doi":"10.37521/EJPPS.25401","DOIUrl":"https://doi.org/10.37521/EJPPS.25401","url":null,"abstract":"Cleanroom garments are used to control the airborne dispersion of contamination from people into the cleanroom. The effectiveness of the garment in controlling the dispersion of contamination is a function of the fabric and design of garments, and test methods used to ascertain the effectiveness of garments are discussed in this article. These test methods can be used when choosing garments for use in a cleanroom but were used in this article to determine the deterioration of garments through use. Cleanroom garments were subjected to increasing numbers of decontamination cycles, which included sterilisation by gamma radiation, up to a maximum of 70. At defined number of decontamination cycles, the garment’s fabric was compared to a new fabric by visual examination, by a scanning electron microscope, and by physical tests of key performance parameters. It was concluded that the performance of the fabric remained acceptable up to 50 decontamination cycles. This conclusion was supported by the low dispersion rate of particles and microbe-carrying particles in a dispersal chamber from personnel wearing the garments. After 50 decontamination cycles, a low dispersion rate of 0.2/s of microbe-carrying particles from personnel wearing the garments was obtained and a 194-fold reduction in the microbial dispersion rate compared to cleanroom undergarments.\u0000 \u0000\u0000Key words: cleanroom garments, garment life, contamination control","PeriodicalId":300408,"journal":{"name":"EJPPS EUROPEAN JOURNAL OF PARENTERAL AND PHARMACEUTICAL SCIENCES","volume":"33 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-01-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"127252452","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":"Gender Influences Bacterial Contamination of Reusable Cleanroom Operators’ Garments following Wear","authors":"Laurie M. Smith, Noëlle H. O’ Driscoll, A. J. Lamb","doi":"10.37521/ejpps25202","DOIUrl":"https://doi.org/10.37521/ejpps25202","url":null,"abstract":"Operators are the primary source of cleanroom contamination, with the majority of their detritus identified as skin squames and their associated microorganisms. To reduce contamination, operatives are required to wear a specific arrangement of specialist garments. However, bacteria can evade this clothing and tarnish outer surfaces whilst operators work, with adverse implication for cleanroom environment and product sterility. Gender plays a significant role in bacterial dispersion, with male rates being in excess of female counterparts. Currently there is a lack of published literature evaluating the effect of gender on contamination of cleanroom garments. Such information would assist cleanroom facilities to more robustly assess and mitigate operator-associated contamination risks.","PeriodicalId":300408,"journal":{"name":"EJPPS EUROPEAN JOURNAL OF PARENTERAL AND PHARMACEUTICAL SCIENCES","volume":"1 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":"131626252","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":"The effect of a pandemic on the Life Sciences industry","authors":"C. McDonough, E. Lockey","doi":"10.37521/ejpps25204","DOIUrl":"https://doi.org/10.37521/ejpps25204","url":null,"abstract":"Pharmaceutical, healthcare and biotech companies have been at the forefront of the COVID-19 response, from drug trials and vaccine development to the production of personal protective equipment (PPE) and ventilators. The industry has a unique ability and responsibility to help the world respond to the global pandemic, both by working collaboratively to deliver solutions to the virus and also by maintaining the supply of medically important products to those who need them. \u0000\u0000As in all industries, business in the sector has been disrupted by the virus. This is largely driven by a reduction in healthcare provider and patient interactions as hospitals redirect resources toward COVID-19, and patients avoid healthcare facility visits and postpone preventative care. The impact on specific companies will depend on the diversity of their portfolio and their largest revenue areas. For example, roughly two thirds of Merck’s global Human Health revenue is comprised of physician-administered products and decreased volumes during the pandemic are expected to have a negative impact on revenues. \u0000\u0000Whilst much of the pandemic impact will be short term, peaking over the next quarter in conjunction with the peak of the virus in the US and Europe and settling towards the end of the year, it is likely we will see some long term structural change in the industry as global attitudes towards health shift in the wake of the pandemic.","PeriodicalId":300408,"journal":{"name":"EJPPS EUROPEAN JOURNAL OF PARENTERAL AND PHARMACEUTICAL SCIENCES","volume":"54 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":"121210443","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":"Validation of the Growth Direct System for Microbial Environmental Monitoring and Define Optimal Incubation Conditions","authors":"C. Russell, Niloufar Parsaei, David L. Jones","doi":"10.37521/ejpps25201","DOIUrl":"https://doi.org/10.37521/ejpps25201","url":null,"abstract":"The validation of the Growth Direct system is described for the automated incubation and enumeration of microbial colonies on TSA LP80 and TSA LP80HT media plates. The analytical validation strategy and data generated are given to demonstrate the technology is validatable following the requirements of USP <1223> for microbial recovery. Single and serial temperature incubations were evaluated to optimize microbial detection. Data is provided to demonstrate equivalence to the current compendia test method for environmental monitoring.","PeriodicalId":300408,"journal":{"name":"EJPPS EUROPEAN JOURNAL OF PARENTERAL AND PHARMACEUTICAL SCIENCES","volume":"5 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":"127802556","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}