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Nanostructured Biomaterials for Load-Bearing Applications
Published in Ashwani Kumar, Mangey Ram, Yogesh Kumar Singla, Advanced Materials for Biomechanical Applications, 2022
One of the essential applications of nanostructured materials in biomedical applications is drug delivery. To reduce the chances of bacterial infection, sterilization is usually performed on biomedical instruments. However, forgetting improved results, the drug delivery is associated with the surface modification by introducing coating of nanostructured particles (antibacterial biomaterials) on the drugs or the implants. Metal nanoparticles like titanium (Ti), silver (Ag), zinc (Zn), zinc oxide (ZnO) and zirconia (ZnO2) are used in implant materials for reducing the bacterial adhesion of the implants. Some metallic, ceramic and polymeric materials are used as drug delivery vehicles or drug carriers in targeted drug delivery systems. The drug delivery system is supposed to enhance the therapeutic efficacy of the drugs along with the safety of therapeutic molecules of drugs.
Japanese Approach to Validation
Published in James Agalloco, Phil DeSantis, Anthony Grilli, Anthony Pavell, Handbook of Validation in Pharmaceutical Processes, 2021
Satoshi Sugimoto, Mitsuo Mori, Kiyoshi Mochizuki, Keisuke Nishikawa, Takuji Ikeda, Yusuke Matsuda, Hiroaki Nakamura, Yasuhito Ikematsu
It is recommended that the propriety of sterilization by terminal sterilization methods should be judged by employing an appropriate sterilization process control and using a sterilization indicator suitable for the selected sterilization method. In moist-heat sterilization and hydrogen peroxide sterilization, Geobacillus stearothermophilus (strain name: ATCC7953, NBRC13737) is recommended and in dry-heat method and/or ethylene oxide (EO) gas sterilization, Bacillus subtilis (strain name: ATCC9372, IFO13721) is recommended as a sterilization indicator.
Sterility in the Biochemical Industries
Published in Debabrata Das, Soumya Pandit, Industrial Biotechnology, 2021
Chemical sterilization is the destruction of all viable microorganisms and their spores using liquid or gaseous compounds such as alcohol, oxidizing agents (chlorine), salts, disinfectant agents etc. Sterilization may be done through either physical removal or destruction of the microorganism by heat. Selective destruction of the microorganism may adversely affect a specific biochemical process. Therefore medium sterilization is based on either removing or destroying all microorganisms or contaminants present in the medium. Thus sterilization of the medium is broadly classified as Filtration or physical removal of microorganisms andDestruction of microorganisms by heat
A new hybrid method to determine the hazardous risk factors
Published in Human and Ecological Risk Assessment: An International Journal, 2022
Esra Dinler, Kumru Didem Atalay, Ezgi Güler
In the United States, approximately 46.5 million surgical procedures and even more invasive medical procedures are performed each year. Each procedure involves contacting the patient’s sterile tissue or mucous membranes with a medical device or surgical instrument. The primary risk of all these procedures is the emergence of pathogens that can lead to infection (Rutala and Weber 2019). Sterilization is the process whereby a substance is purified from microorganisms on or in the substance—the killing of all living microorganisms, including bacterial spores (Sandler 2013). The method developed in this study uses data obtained on hydrogen peroxide plasma sterilizer. Hydrogen peroxide is a highly reactive substance that reacts with essential cell components and disrupts the metabolism of microorganisms (Moisan et al. 2001).
Low-cost biofuel-powered autoclaving machine for use in rural health care centres
Published in Journal of Medical Engineering & Technology, 2020
Yusuf Kola Ahmed, Morufu Olusola Ibitoye, Abdul Rasak Zubair, Janet Mosunmola Oladejo, Suleiman Abimbola Yahaya, Saheed Olayinka Abdulsalam, Ridwan Oladipupo Ajibola
Sterilisation is an integral part of regular activities in any functional health care centre either to ensure safe disposal of some medical wastes or decontamination of reusable medical devices. Effective sterilisation of medical devices is necessary to prevent healthcare-associated infections (HAI) such as nosocomial infection and surgical site infection (SSI) [1,2]. SSI(s) are infections acquired by patients within 30 d or more after an operative procedure [1]. In 2011, World Health Organisation (WHO) submitted that HAI is a significant burden in developed countries as about 15% of patients in regular wards and over 50% patients in intensive care units (ICU) were affected [2,3]. For example, an average of 500,000 cases of SSI is recorded annually in the United States alone [4]. Although there are few statistics available from developing countries about HAI as resources and expertise needed for such records are limited, the available data indicated that their cases of HAI are higher [2]. The WHO’s report established that about 23.6% of procedures are affected by SSI in developing countries, while only 5.2% of procedures are affected in developed nations [1]. Nigeria, being a prominent country in Africa, is reported to have 30.9% of her paediatric hospital procedures affected by SSI [5]. Another study conducted in a Nigerian teaching hospital by Olowo-okere et al. [6] reported 27.6% of hospital procedures being affected by SSI in 2018.
PEGylated microemulsion for dexamethasone delivery to posterior segment of eye
Published in Journal of Biomaterials Science, Polymer Edition, 2020
Present work involved development of Dex loaded PEGylated ME which was in nano-regime (15.98 ± 3.05 nm), homogenous and stable. PD was stable at different temperatures in terms of size, PDI and drug content over the period of 3 months. It released entire loaded drug without any burst effect within 10 h which is in harmony with desired release pattern from nanoformulation aimed for topical ocular use (in vitro drug release study). PEGylation doesn’t hinder the drug release from ME droplet. Topical ocular formulation should be sterile, isotonic and non-irritant. As PD was prepared under aseptic conditions, it sufficed the requisite of sterility which was evident from sterility study. Further sterilization can be obtained by filtration with 0.2 µm filter membrane. No morphological changes in RBCs on incubation with developed MEs confirmed isotonicity. H&E staining on goat cornea and HET-CAM study on fertilized hen’s eggs support non-irritancy of formulations. PD was sterile, isotonic and non-irritant as characterized in in vitro and ex vivo studies. Careful screening and optimization of formulation constituents and preparation resulted into this stable and non-toxic ocular formulation. In vitro cell line studies not only established non-irritancy and stability of PD but also emphasized its ability to cross CE. PD being ME had very flexible architecture which helped its droplets to cross CE as whole without any disruption of tight junction of CE.