EJPPS EUROPEAN JOURNAL OF PARENTERAL AND PHARMACEUTICAL SCIENCES最新文献

{"title":"Inventory of the Sterilization Units at a Tertiary-Level South Tunisian University Hospital","authors":"Mouna Mouna Baklouti, H. Ben Ayed, M. Ben Hmida, N. Ketata, Afef Bouazizi, Hbiba Hosni, Mariem Jebli, Mondher Kassis, S. Yaich, Jamel Dammak","doi":"10.37521/2903","DOIUrl":"https://doi.org/10.37521/2903","url":null,"abstract":"Sterilization of reusable medical devices (RMD) is considered as one of the major components of healthcare associated infection (HAI) prevention that should be strictly maintained. Microorganisms responsible for HAI can be transmitted from a common inanimate vehicle such as medical RMD to patients. Sterilization is a complete process with a set of successive steps to finally achieve a sterile RMD. In addition to these steps, which must be carefully controlled, the whole environment of this process should also conform to quality and security standards and criteria in order to ensure a robust sterilization process and a secure RMD. Therefore, a complete and exhaustive evaluation of this process is highly recommended. This evaluation aimed firstly to examine the inventory of sterilization process, architecture, and environment as well as to present recommendations to be adopted to adjust the practices and failures recorded accordingly.","PeriodicalId":300408,"journal":{"name":"EJPPS EUROPEAN JOURNAL OF PARENTERAL AND PHARMACEUTICAL SCIENCES","volume":"21 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141641663","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":"An Alternative Medium to Support Sterility Testing using the Growth Direct® Rapid Sterility System","authors":"DL Jones, K. Volis, O. Griffin","doi":"10.37521/29202","DOIUrl":"https://doi.org/10.37521/29202","url":null,"abstract":"Recently, it has been shown that there are other media that perform equivalently or better than the compendial sterility test media, TSB and FTM1. The results presented here demonstrate that a new single medium, Rapid Sterility Medium (RSM) Broth, performs as well as or better for the growth promotion of test organisms compared to compendial sterility test media. In side-by-side tests of aerobic bacteria, yeast and molds and anaerobic organisms, RSM broth supported growth promotion comparable to TSB or FTM for a panel of microorganisms relevant to the pharmaceutical market. These results demonstrate that RSM broth can serve as a valid alternative for both TSB and FTM for sterility testing being performed by the Growth Direct® Rapid Sterility System.\u0000\u0000 \u0000\u0000Keywords: Sterility test, Alternative media, Rapid Microbial Method, Growth Direct System®","PeriodicalId":300408,"journal":{"name":"EJPPS EUROPEAN JOURNAL OF PARENTERAL AND PHARMACEUTICAL SCIENCES","volume":"20 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141641453","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":"Particle Matter determination in Biosimilar Parenteral Product by the Application of Dynamic Light Scattering (DLS) Followed by Statistical Evaluation","authors":"Akhilesh Kumar Kuril, K. Saravanan","doi":"10.37521/29201","DOIUrl":"https://doi.org/10.37521/29201","url":null,"abstract":"Particulate matter in parenteral dosage forms can emerge from numerous causes, external, intrinsic, as well as inherent within the product, with a special emphasis on biopharmaceuticals. Aqueous impurities, pharmaceutical precipitates, dirt, glass, rubber, pollutants from the environment, fibres, and various other insoluble materials are all common sources of particulates. When assessing the possible harm to patients, particulate matter size is a crucial issue to consider. Particles as fine as 2 μm overall diameter were found related with microthrombi development. The DLS (Dynamic Light Scattering) technique has been used to measure and control the subvisible particulate particles in biopharmaceutical parenteral drug products since the technique can measure the submicron particle size in the parenteral formulation. The purpose of using DLS is to measure and control the subvisible particles in a biopharmaceutical formulation. A generic biopharmaceutical product viz. Calcitonin Salmon injection was used for particulate matter analysis by using Dynamic Light Scattering. \u0000\u0000DLS is a non-invasive method for detecting the size of suspended particles as well as molecules which is used for the control and optimization of processes, and the improvement of product quality and performance by analysing the time-dependence in regard to intensity of the dispersed light (auto correlation) to determine the diffusion speed (Brownian motion) of particles/molecules, and subsequently determine the hydrodynamic size.\u0000\u0000 \u0000\u0000Keywords: Particulate matter; DLS; Biosimilars; Parenteral dosage forms","PeriodicalId":300408,"journal":{"name":"EJPPS EUROPEAN JOURNAL OF PARENTERAL AND PHARMACEUTICAL SCIENCES","volume":"12 4","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141641523","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":"Evaluation of Three Different Contact Plate Methods for Microbial Surface Sampling of Naturally Occurring Human Borne Microbial Contamination","authors":"Tim Eaton, Karen Capper, M. Ward, J. Bright","doi":"10.37521/ejpps.29101","DOIUrl":"https://doi.org/10.37521/ejpps.29101","url":null,"abstract":"The ability of irradiated 55 mm diameter tryptone soya agar contact plates to recover naturally occurring surface microbial contamination, using three different manual sampling procedures, was investigated. The investigation was completed by sampling hard surfaces contaminated with microbe-carrying particles (MCPs) dispersed from a person within heavily populated environments. This is more representative of the contamination that is found within cleanrooms and avoids issues resulting from the utilisation of standard commercial test organisms to distribute unicellular microbes onto surfaces, which are likely to be transferred to the plate with different efficiencies compared to the naturally occurring MCPs. It was determined that rolling the contact plate media over the surface, using firm pressure for either 1 or 5 seconds recorded little differences in the mean recovery efficiencies (53% and 48% respectively). However, both recorded significantly higher efficiencies than just a single 1 second press of the media onto the surface with firm pressure (16%). \u0000\u0000\u0000Introduction\u0000For sterile products manufacturing, it is a requirement of Annex 1 of the European Union Guide to Good Manufacturing Practice (EU GGMP) ¹ that microbiological monitoring of cleanrooms includes the use of 55 mm diameter contact plates for sampling defined surface locations. The Guide includes limits to be applied to this monitoring and the expectation is that supporting data for the recovery efficiency of the sampling method should be available. \u0000\u0000Typically, circular RODAC (replicate organism detection and counting) plates (55 mm diameter, 24 cm² surface area) containing nutrient agar (between 15.5 and 16 ml) are used for sampling surfaces that are relatively flat. They are poured to give an agar meniscus that protrudes just above the rim, and are based upon plates that were originally reported on in 1964 ². They are easy to use and require minimal training and the full area of the nutrient agar is rolled over the surface to be sampled, facilitated by the convex media profile, or they can be applied to the surface for a few seconds ensuring uniform and steady pressure with no rolling action. Viable particles removed from the surface adhere to the agar and the lidded plates are then incubated and examined and the number of colony forming units (CFU) and types of micro-organisms recovered are reported and the results expressed as the number of CFU per plate. \u0000\u0000The recovery efficiency will be affected by many factors, including the sort of plate media used, the type of micro-organisms present on the surface and the material and finish of the surfaces ³ to be sampled. It will also be influenced by the contact area of the plate media with the surface being sampled and may be influenced by the associated duration of this contact, both of which are associated with the plate sampling method. To reduce variations associated with these two parameters, there are commercially available plate ","PeriodicalId":300408,"journal":{"name":"EJPPS EUROPEAN JOURNAL OF PARENTERAL AND PHARMACEUTICAL SCIENCES","volume":"10 8","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140748008","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 comparative study of a standard slit-to-agar sampler and a real-time bacterial detector","authors":"Berit Reinmuller, Bengt Bengt Ljungqvist, Johan Nordenadler","doi":"10.37521/ejpps.29102","DOIUrl":"https://doi.org/10.37521/ejpps.29102","url":null,"abstract":"A comparison is presented of data from simultaneous measurements of airborne particles by a standard slit-to-agar sampler (STA) and of fluorescent particles by a real-time bacterial detector, Bio Aerosol Monitoring System (BAMS) during an evaluation regarding emitted airborne particles of a surgical clothing system in a test chamber. Data from simultaneous orientating measurements of airborne particles by a standard discrete particle counter are also discussed. \u0000\u0000The results show that in an environment with a low level of airborne particles including CFUs and man the only contamination source, there is a moderate correlation between the number of aerobic CFU and BAMS viable, i.e., fluorescence, particles, when the slit-to-agar sampler is registering/collecting within its detection level. \u0000\u0000Different environments need simultaneous measurements by an STA in aerobic CFU/m³ and by a BAMS in viable particles/m³ to set up the correlation between the two methods. \u0000\u0000Keywords: Airborne particles, controlled environment, CFU, fluorescent particles, real-time measurements, viable particles.","PeriodicalId":300408,"journal":{"name":"EJPPS EUROPEAN JOURNAL OF PARENTERAL AND PHARMACEUTICAL SCIENCES","volume":"852 ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140749142","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":"Improved Dissolution and Solubility Characteristics of Clopidogrel Bisulphate using Gelucire 44/14","authors":"Urvashi Sharma, Shikha Agrawa, Mahavir Chhajed, Sumeet Dwived","doi":"10.37521/ejpps.29103","DOIUrl":"https://doi.org/10.37521/ejpps.29103","url":null,"abstract":"Clopidogrel bisulphate is a poorly aqueous soluble drug belonging to BCS Class II. The drug is widely used to treat blood clotting in patients with peripheral, coronary, and cerebrovascular disorders, but its low bioavailability raises concern. The present study involves an effort for enhancing the solubility and drug release by transforming the drug into solid dispersions. The solid dispersions of clopidogrel bisulphate were prepared with Gelucire 44/14 using solvent evaporation method. The prepared physical mixture and solid dispersions were characterized for drug-carrier interaction, drug content, solubility, and dissolution rate. Results confirmed the increase in drug solubility with increasing polymer concentration. The dissolution profile was found to substantially improve from solid dispersion with maximum drug release in the ratio of 1:5 on comparing it with pure drug and physical mixture. FT‐IR spectra of selected solid dispersion revealed no chemical interaction between drug and polymers while the presence of the drug in the amorphous state was confirmed by DSC thermograms and X-ray diffraction, indicating better dissolution characteristics. The solid dispersions were also found to be stable under accelerated stability conditions.\u0000\u0000Keywords: Clopidogrel bisulphate, Bioavailability, Solid dispersions, Gelucire 44/14, Solubility Enhancement","PeriodicalId":300408,"journal":{"name":"EJPPS EUROPEAN JOURNAL OF PARENTERAL AND PHARMACEUTICAL SCIENCES","volume":"306 ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140749888","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":"Enzymatic Indicators in Vaporized Hydrogen Peroxide Decontamination Cycles: Application-related Research focusing on Fractional Kill Time (FKT) and Reverse Fractional Kill Time (RFKT) Studies","authors":"Birte Scharf, Marina Gole, Marcel Kötter","doi":"10.37521/ejpps.28403","DOIUrl":"https://doi.org/10.37521/ejpps.28403","url":null,"abstract":"The accepted standard from a regulatory perspective for vaporized hydrogen peroxide (vH2O2) cycle validation is the use of biological indicators (BIs). Novel enzymatic indicators (EIs) are gaining more importance in this field, relying on specific enzymatic reactions for their functionality. The aim of this work is to determine how enzymatic indicators can contribute to the cycle development process. Emphasis was placed on the initial informative study, the fractional kill time study, which is a basis for future studies. The results indicate that enzymatic indicators have the potential to facilitate further development of the cycle. This requires an analysis of the determined data, measured in relative light units (RLU), and aligning it with the BI growth, resulting in Full Kill/ No Kill limits. The use of enzymatic indicators for decontamination cycle development opens new perspectives and holds considerable potential for practical use in the development and validation of decontamination processes.","PeriodicalId":300408,"journal":{"name":"EJPPS EUROPEAN JOURNAL OF PARENTERAL AND PHARMACEUTICAL SCIENCES","volume":"62 3","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139169353","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":"Protective Airflow including ‘First Air’ in GMP Aseptic manufacturing","authors":"James Drinkwater, Di Morris","doi":"10.37521/ejpps.28406","DOIUrl":"https://doi.org/10.37521/ejpps.28406","url":null,"abstract":"Good Manufacturing Practices (GMP) related to sterile product aseptic manufacturing environments rely on protective airflow mechanisms to ensure the control over airborne contamination. Alongside the protective airflow, pressure differentials that drive airflow cascade ensure GMP compliant contamination control of airborne contamination that may include Microbial carrying particles (MCPs). Airflow visualisation qualification by smoke studies has been clarified as a GMP requirement in EU & PICS Annex 1. The scope of Annex 1 applies to manufacture of sterile medicinal products together with bioburden control processes where bioburden in intermediates, substances, APIs and non-sterile products can also impact patient safety so a wide scope of protective airflow applications is applied. \u0000\u0000As a GMP requirement (included in 2008 version of Annex 1): It should be demonstrated that air-flow patterns do not present a contamination risk, e.g. care should be taken to ensure that air flows do not distribute particles from a particle generating person, operation or machine to a zone of higher product risk.'\u0000\u0000Within Annex 1: 2023, the concept of First Air has emerged as a critical element. First Air is defined as “filtered air that has not been interrupted prior to contacting exposed product and product contact surfaces with the potential to add contamination to the air prior to reaching the critical zone.” \u0000\u0000The requirement for extensive smoke studies and the integration of First Air protection as a mandated aspect in GMP regulations has brought to the fore an imperative need for a deeper comprehension of airflow dynamics and their implications on sterile product Aseptic manufacturing. This shift beckons us to explore the nuances of protective airflow, particularly in the context of Computational Fluid Dynamics (CFD) analyses, to discern the efficacy of airflow patterns in different scenarios.\u0000\u0000Stakeholders involved in Annex 1 implementation have been impacted by introduction of the First Air protection requirement, considering design and in qualification via smoke study airflow visualisation. Such requirements must follow QRM principles where process understanding and knowledge of contamination hazards are essential to mitigate risks in compromise of product quality and potential harm to patients. Risk mitigations must take a Quality by Design (QbD) approach as monitoring alone does not provide assurance of product sterility or in meeting defined bioburden limits.","PeriodicalId":300408,"journal":{"name":"EJPPS EUROPEAN JOURNAL OF PARENTERAL AND PHARMACEUTICAL SCIENCES","volume":"48 16","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138955556","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":"Designing drug delivery systems through additive manufacturing","authors":"Deepak Yadav, Kajal Sonkar, Jatin Kumar, Amit Chaudhary","doi":"10.37521/ejpps.28402","DOIUrl":"https://doi.org/10.37521/ejpps.28402","url":null,"abstract":"Additive manufacturing, also called 3D-printing is an emerging technique for the formulation of drug dosage forms in pharmaceutical formulation. This approach is widely used for its benefits over conventional drug formulations. 3D printing is giving an enhancement to the customization of drugs. This technique is able to carry many different drugs in a single dosage form. Customization is also seen in conventional drug dosage forms, but 3D printing gives more precision as per pharmacological response desired for each individual patient. Moreover, the customisation process is simple and instant production is obtained. Physically incompatible drugs can be added to one drug dosage form by providing barriers of polymers, etc. Here, we have discussed some of the tablets, capsules, transdermal patches, suppositories fabricated by 3D printing by researchers. Different types of techniques under 3D printing have also been discussed which are being used in fabricating the above-mentioned drug dosage forms. 3D printing is being considered in the pharmaceutical field due to its advantages of easy operation, the fewest possible steps, lower labour costs and many other factors. This technique shows the benefits of 3D printing of various desirable drugs.  \u0000\u0000Keywords: 3-D Printing, Polymer, Dosage form, Customization, Capsule, Transdermal patches, suppositories. \u0000\u0000Abbreviations: HCl- Hydrochloric acid, FDM- Fused Deposition Modelling, FDA- Food and Drug administration, CADD- Computer aided drug design, API- Active pharmaceutical agent, SLA- Stereolithography, SLS- selective laser sintering, 3D- Three dimensional","PeriodicalId":300408,"journal":{"name":"EJPPS EUROPEAN JOURNAL OF PARENTERAL AND PHARMACEUTICAL SCIENCES","volume":"44 6","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138955488","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":"An Investigation of the Visual Impact of the Combined Exposure to Residual Cleaning Agents and Vaporized Hydrogen Peroxide on Materials used in Barrier Systems","authors":"Marina Gole, Birte Scharf, Airin Franke, Karin Mittmann","doi":"10.37521/ejpps.28401","DOIUrl":"https://doi.org/10.37521/ejpps.28401","url":null,"abstract":"Vaporized Hydrogen Peroxide (vapor-phase hydrogen peroxide, vH₂O₂) treatment is the main approach for sporicidal surface bio-decontamination in restricted access barrier systems and isolators. Prior to vH₂O₂ exposure, surfaces are cleaned to prepare the barrier system for the decontamination cycle, removing surface residues that could impede the cycles effectiveness. The presence of residual cleaning agents alongside vH₂O₂ exposure could potentially impact the integrity and longevity of materials, necessitating a comprehensive understanding of these interactions.\u0000\u0000To gain more knowledge about the influence of cleaning agents and vH₂O₂, various materials were exposed to a combination of cleaning agents and vH₂O₂ in order to visually assess the interaction.\u0000\u0000Introduction:\u0000\u0000Vaporized Hydrogen Peroxide has emerged as a valuable tool for bio-decontamination due to its ability to efficiently eliminate a wide range of microorganisms, including bacteria, viruses, and spores [1]. The penetration of vH₂O₂ is limited, so surfaces are cleaned to remove contaminants that may interfere with vH₂O₂ penetration and effectiveness prior to vH₂O₂ exposure. While studies have investigated the compatibility of materials with vH₂O₂ or cleaning agents alone [2,3], the interactions between residual cleaning agents and vH₂O₂ have received limited attention until now.\u0000\u0000Residual cleaning agents might persist even after thorough rinsing, potentially influencing the interaction of the vapour phase gas with materials. Reactive components within cleaning agents could react with vH₂O₂, probably leading to material deterioration, discoloration, or altered mechanical properties. Additionally, accumulated residues within surface microstructures might hinder vH₂O₂ diffusion, thus impacting its efficacy. Investigating these combined effects is pivotal to prevent unintended material outcomes during decontamination processes.","PeriodicalId":300408,"journal":{"name":"EJPPS EUROPEAN JOURNAL OF PARENTERAL AND PHARMACEUTICAL SCIENCES","volume":"90 25","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138957842","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}