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"This book gives an overview of commonly-used disposables in the manufacture of biopharmaceuticals, their working principles, characteristics, engineering aspects, economics, and applications. With this information, readers will be able to come to an easier decision for or against disposable alternatives and to choose the appropriate system. The book is divided into two parts. The first is related to basic knowledge about disposable equipment; and the second discusses applications through case studies that illustrate manufacturing, quality assurance, and environmental influence."

"Pandemi COVID-19 menyebabkan peningkatan konsumsi masker sekali pakai dalam pencegahan penularan virus SARS-CoV-2 yang mengakibatkan akumulasi limbah masker sekali pakai. Polipropilena sebagai bahan utama masker membuat masker sulit untuk terurai secara alami. Larva T. molitor diketahui dapat mendegradasi berbagai jenis plastik secara fisik dan in-situ. Namun belum ada studi yang menjelaskan kemampuan degradasi masker secara ex-situ dari mikroba konsorsium saluran pencernaan larva T. molitor. Penelitian ini diawali dengan budidaya larva dengan pemberian pakan 100% masker sekali pakai sebagai dasar untuk mengevaluasi konsorsium bakteri yang digunakan untuk degradasi ex-situ. Konsorsium mikroba dari pencernaan larva diekstraksi untuk analisis metagenomik dan ditumbuhkan melalui proses fermentasi dalam Minimum Salt Media (MSM) dan potongan masker sekali pakai yang terdiri dari lapisan luar, tengah, dan dalam dengan ukuran 3 x 3 cm selama 52 hari di bioreaktor batch berukuran 500 mL. Analisis metagenomik menunjukkan keragaman mikroba yang didominasi oleh Klebsiella aerogenes, Tenebrionicola larvae, Enterobocater, Lactococcus garvieae, dan Lactococcus formosensis. Pertumbuhan mikroba selama fermentasi mengalami peningkatan nilai optical density (OD) yang diukur menggunakan spektrofotometer UV Vis (600 nm). Tingkat konsumsi masker lapisan luar, tengah, dan dalam diperoleh masing-masing sebesar 19,200%±0,031, 30,333%±0,031, dan 26,400%±0,040. Biodegradasi masker sekali pakai dibuktikan melalui pengurangan massa dari masker. Selain itu, perubahan fisik pada masker seperti kerusakan permukaan, goresan, dan perubahan gugus fungsi dikonfirmasi melalui Scanning Electron Microscopy (SEM) dan Fourier Transform Infrared Spectroscopy (FTIR). Temuan ini menunjukkan bahwa konsorsium mikroba dari saluran pencernaan T.molitor dapat mendegradasi masker sekali pakai secara ex-situ sebagai salah satu upaya penyelesaian akumulasi limbah masker sekali pakai yang berkelanjutan.

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The COVID-19 pandemic has led to a surge in the use of single-use masks to prevent the transmission of the SARS-CoV-2 virus, resulting in significant mask waste accumulation. These masks are primarily made of polypropylene, a material that does not decompose naturally. T. molitor larvae have been shown to degrade various plastics physically and in-situ, but there is limited research on their ability to degrade masks ex- situ using microbes from their gut. This study aimed to explore this potential by first cultivating larvae fed exclusively on single-used masks to establish a basis for evaluating the microbial consortia involved in ex-situ degradation. The microbial consortium from the larvae's gut was extracted for metagenomic analysis and then cultured through a fermentation process in Minimum Salt Media (MSM) with pieces of single-used masks measuring 3 x 3 cm sections of outer, middle, and inner layers) for 52 days in a 500 mL batch bioreactor. Metagenomic analysis revealed a microbial diversity dominated by Klebsiella aerogenes, Tenebrionicola larvae, Enterobocater, Lactococcus garvieae, and Lactococcus formosensis. During fermentation, microbial growth was monitored by measuring the optical density (OD) at 600 nm using a UV-Vis spectrophotometer. The consumption levels of the mask's outer, middle, and inner layers were 19.200%±0.031, 30.333%±0.031, and 26.400%±0.040, respectively, as indicated by the reduction in mask mass. Physical changes to the mask, such as surface damage, scratches, and alterations in functional groups, were confirmed through Scanning Electron Microscopy (SEM) and Fourier Transform Infrared Spectroscopy (FTIR). These findings suggest that a microbial consortium from the gut of T. molitor can effectively degrade single-use masks ex-situ, offering a promising solution for managing single-use mask waste sustainably."

"Focused manuscript on the potential use/role of miRNAs in bioprocessing, specifically the production of complex proteins in mammalian cells. With that in mind I propose a draft list of topics/chapters along the following lines, intro on CHO/bioprocessing/engineering challenges to set scene, genomic organization, biogenesis and mode of action, Identifying miRNA targets, computational prediction, transcriptomics, proteomices, UTR analysis, etc., miRNA expression in Chinese hamster ovary cells, miRNAs as engineering targets: pathway manipulation to impact bioprocess phenotypes, miRNAs as biomarkers, detection methods : northern, PCR, hybridization arrays, next gen seq, manipulation of expression in cultured cells : transient/stable disregulation, knockout."

"Alat kesehatan sekali pakai merupakan perangkat kesehatan yang dirancang untuk satu kali penggunaan pada seorang pasien setiap satu prosedur. Dalam beberapa waktu terakhir, sejumlah rumah sakit secara internal telah melalukan pemrosesan ulang alat kesehatan sekali pakai untuk digunakan kembali. Praktik penggunaan kembali alat kesehatan sekali pakai di RSUI dilakukan dengan pemrosesan ulang di Central Sterile Supply Department (CSSD). Pemrosesan ulang tersebut melalui tahap pembersihan, disinfeksi, dan sterilisasi dengan prosedur lengkap. Penelitian ini dilakukan untuk mengevaluasi penggunaan alat kesehatan sekali pakai pada Rumah Sakit Universitas Indonesia (RSUI). Evaluasi ini penting agar dapat meminimalisir risiko penularan infeksi yang membahayakan keselamatan pasien. Dengan menggunakan metode penelitian deskriptif observasional dengan desain prospektif, dilakukan evaluasi terhadap fungsi dan sterilitas alat kesehatan sekali pakai yang digunakan kembali. Observasi dilakukan di CSSD dengan membagikan formulir penilaian fungsi alat kepada para pengguna alat, dan mengirimkan beberapa sampel alat untuk diuji sterilitasnya di Laboratorium Kesehatan DKI. Hasil menunjukkan dari 10 alat kesehatan sekali pakai yang di-resterilisasi menggunakan Etilen Oksida (EO), 7 alat dapat digunakan kembali sebanyak 2 kali, sementara 3 alat sisanya dapat digunakan kembali sebanyak 1 kali. Selain itu, evaluasi sterilitas menunjukkan bahwa 5 alat kesehatan sekali pakai masih steril setelah dilakukan penggunaan berulang.

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Disposable medical devices are healthcare tools designed for one-time use on a patient during a single procedure. Recently, some hospitals have internally engaged in reprocessing of disposable medical devices for reuse. The practice of reusing single-use medical devices at UI Hospital is carried out through reprocessing in the Central Sterile Supply Department (CSSD). The reprocessing involves cleaning, disinfection, and sterilization following complete procedures. This study was conducted to evaluate the use of disposable medical devices at RSUI. Such evaluation is essential to minimize the risk of infection transmission that could jeopardize patient safety. Employing a descriptive observational research method with a prospective design, the evaluation focused on the functionality and sterility of the reprocessed disposable medical devices. Observations were carried out in the CSSD by distributing assessment forms for the device users and sending some device samples for sterility testing at the Health Laboratory of DKI Jakarta. The results showed that out of 10 disposable medical devices resterilized using Ethylene Oxide (EO), 7 devices could be reused twice, while the remaining 3 devices could be reused once. Additionally, the sterility evaluation indicated that 5 disposable medical devices remained sterile after repeated use."

"Validation describes the procedures used to analyze pharmaceutical products so that the data generated will comply with the requirements of regulatory bodies of the US, Canada, Europe and Japan. Calibration of Instruments describes the process of fixing, checking or correcting the graduations of instruments so that they comply with those regulatory bodies. This book provides a thorough explanation of both the fundamental and practical aspects of biopharmaceutical and bioanalytical methods validation. It teaches the proper procedures for using the tools and analysis methods in a regulated lab setting. "

"Pharmaceutical and Biomedical Portfolio Management in a Changing Global Environment explores some of the critical forces at work today in the complex endeavour of pharmaceutical and medical product development. Written by experienced professionals, and including real-world approaches and best practice examples, this new title addresses three key areas, small molecules, large molecules, and medical devices, and provides hard-to-find, consolidated information relevant to and needed by pharmaceutical, biotech, and medical device company managers. "

"Pengeringan konvektif adalah jenis pengeringan yang paling sering digunakan di industri pengeringan makanan. Tetapi pengering konvektif umum mempunyai efisiensi rendah dan konsumsi daya yang tinggi. Untuk mengatasi masalah ini, sebuah pengering makanan dengan teknologi konvektif, microwave, dan heat pump di desain. Sebuah investigasi dilakukan untuk menemukan desain yang cocok. Tinjauan literatur dilakukan terhadap komponen-kompoen yang akan dipakai. Hasil tinjauan literatur menunjukkan bahwa microwave mampu mencapai tingkat pengeringan yang lebih tinggi dan kualitas yang lebih baik, tetapi memakai lebih banyak daya. Heat pump mampu mencapai efisiensi tinggi karena kemampuannya untuk mendaur ulang energi panas yang digunakan untuk pengeringan dan kontrol kelembaban yang lebih baik. Beberapa jenis pengering telah diteliti, dan dua jenis pengering dianggap layak. Jenis pengeringnya adalah pengering batch tray dan pengering continuous conveyor. Sebuah diagram sederhana dibuat terlebih dahulu untuk menunjukkan proses dasarnya. Sketsa yang lebih mendalam dibuat untuk menunjukkan lokasi komponen. Berdasarkan sketsa tersebut, pengering kemudian dimodelkan dalam 3D menggunakan software CAD.

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Convective drying is the most common type of food drying used in the industry. But convective drying has low drying efficiency and high power consumption. To mitigate this problem, a food dryer with convective, microwave, and heat pump technology was designed. An investigation was done to find the suitable design. A literature review was done on the components of the dryer and the types of dryers currently available. Scientific literatures shows that microwave is able to achieve higher drying rate and better quality at the cost of power consumption. Heat pump is able to achieve high efficiency due to its ability to recycle the thermal energy used for the drying and better humidity control. Several dryer types were researched, and two types of dryers was deemed to be viable for the project. The dryer types are batch tray dryer and continuous conveyor dryer. A simple diagram was made first to show the basic process. A more in-depth sketch was created to show the locations of the components. Based of those sketches, the dryer is then modelled in 3D using a CAD software."