European Journal of Parenteral and Pharmaceutical Sciences

A sampler that detects and counts ‘viable’ airborne particles in real-time was evaluated for potential use in cleanrooms used for aseptic manufacture. When tested within an environment deliberately enhanced with high numbers of microbe-carrying particles (MCPs), the sampler reported 4.8 times higher numbers of airborne ‘viables’ compared to the number of CFUs recovered by a traditional microbial air sampler and it is considered that this increased level may not be overly unrealistic. However, for similar testing within an environment enhanced with a high concentration of inanimate particles, but with extremely low levels of viable MCPs, the sampler reported 197 times higher numbers of airborne ‘viables’ compared to the number of recovered CFUs but it is considered that many of these were actually sourced from inanimate materials which intrinsically fluoresce and are therefore recorded as ‘viables’. If such a sampler is to be considered for cleanroom monitoring, comprehensive investigative work should be completed to determine the likely increase in the concentrations of reported ‘viables’ and the impact to the manufacturing operation, with the possibility of the introduction of scientifically justified limits, based upon the technology associated with real-time samplers, that, would need to be agreed with the relevant regulatory authority. For critical workstations, where the expectation is that no microbial contamination is recovered, investigative work to identify those inanimate materials that are reported to be ‘viables’ would need to be completed to provide a full understanding, so they can be eliminated or minimised. In these situations, real-time alert may be beneficial if the proportion of any implicated product could be immediately segregated, rather than waiting for the delayed reporting of any conventional CFUs, in which case, all of the manufactured product may have to be discarded. Key words: Cleanroom; real-time microbial air sampler; ‘viables’, fluorescence; microbe-carrying particles (MCPs); airborne microbial contamination

Tim Eaton

Karen Capper

A Jones

European journal of parenteral & pharmaceutical sciences

Evaluation of a Real Time Airborne ‘Viables’ Particle Counter

实时机载“活粒子”计数器评估

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. Characteristics of the novel coronavirus Coronaviruses (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. The 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.

Tim Sandle

Review of the efficacy of HEPA filtered air to control coronavirus risks in cleanrooms

洁净室中使用高效空气过滤器控制冠状病毒风险的效果评估

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). It 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.

James Drinkwater

Di Morris

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.

屏障技术建议文本：PHSS 附件1 焦点小组针对附件1第12版修订条款/章节通过目标咨询程序的建议。

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 &lt;1223&gt; 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.

Courtney Russell

Niloufar Parsaei

David L Jones

Validation of the Growth Direct System for Microbial Environmental Monitoring and Define Optimal Incubation Conditions

生长直接系统在微生物环境监测中的验证及最佳培养条件的确定

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. As 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. Whilst 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.

Cliodhna McDonough

Emily Lockey

The effect of a pandemic on the Life Sciences industry

大流行对生命科学产业的影响

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. DLS 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. Keywords: Particulate matter; DLS; Biosimilars; Parenteral dosage forms

Akhilesh Kumar Kuril

K Saravanan

Particle Matter determination in Biosimilar Parenteral Product by the Application of Dynamic Light Scattering (DLS) Followed by Statistical Evaluation

生物类似药注射产品中颗粒物测定：应用动态光散射（DLS）后的统计评估

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.

Mouna Mouna Baklouti

Houda Ben Ayed

Mariem Ben Hmida

Nouha Ketata

Afef Bouazizi

Hbiba Hosni

Mariem Jebli

Mondher Kassis

Sourour Yaich

Jamel Dammak

Inventory of the Sterilization Units at a Tertiary-Level South Tunisian University Hospital

突尼斯南部某三级大学医院消毒设备清单

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. Keywords: Sterility test, Alternative media, Rapid Microbial Method, Growth Direct System®

DL Jones

K Volis

O Griffin

An Alternative Medium to Support Sterility Testing using the Growth Direct® Rapid Sterility System

一种替代介质用于支持使用Growth Direct®快速无菌系统进行无菌检测

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. Keywords: Clopidogrel bisulphate, Bioavailability, Solid dispersions, Gelucire 44/14, Solubility Enhancement

Urvashi Sharma

Shikha Agrawa

Mahavir Chhajed

Sumeet Dwived

Improved Dissolution and Solubility Characteristics of Clopidogrel Bisulphate using Gelucire 44/14

使用Gelucire 44/14改善氯吡格雷硫酸氢盐的溶解性和溶出特性

出版信息	出版商: Pharmaceutical and Healthcare Sciences Society，出版周期: ，期刊类型: journal，开源期刊: 否
基本数据	创刊年份: 2010，原创研究文献占比: 0.00%，自引率:N.A.， Gold OA占比: 0.00%

European Journal of Parenteral and Pharmaceutical Sciences

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Evaluation of a Real Time Airborne ‘Viables’ Particle Counter

Review of the efficacy of HEPA filtered air to control coronavirus risks in cleanrooms

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.

Validation of the Growth Direct System for Microbial Environmental Monitoring and Define Optimal Incubation Conditions

The effect of a pandemic on the Life Sciences industry

Evaluation of a Real Time Airborne ‘Viables’ Particle Counter

Particle Matter determination in Biosimilar Parenteral Product by the Application of Dynamic Light Scattering (DLS) Followed by Statistical Evaluation

Inventory of the Sterilization Units at a Tertiary-Level South Tunisian University Hospital

An Alternative Medium to Support Sterility Testing using the Growth Direct® Rapid Sterility System

Improved Dissolution and Solubility Characteristics of Clopidogrel Bisulphate using Gelucire 44/14

ISSN	1740-6277, 2633-6588
h-index	7