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Microbiology of Sterilization Processes
Published in James Agalloco, Phil DeSantis, Anthony Grilli, Anthony Pavell, Handbook of Validation in Pharmaceutical Processes, 2021
Water is the most widely used excipient in the pharmaceutical/biotechnological industry. Water is also used in the cleaning and sanitization of the equipment and facilities. Water used as an excipient in formulations intended to be sterile must be USP Water for Injection (WFI). The quality of WFI is governed by the USP monograph on WFI and includes specifications for conductivity and total organic carbon (62). Microbiological relevant guidelines for water are discussed in the USP (62). The USP chapter includes guidance on microbial levels which are de facto specifications. From the sterilization point of view, water borne contaminants are most commonly gram-negative microorganisms that have little resistance to sterilization. However, the production of endotoxins by these gram-negative microorganisms can present problems.
Water Systems for Parenteral Facilities
Published in Sandeep Nema, John D. Ludwig, Parenteral Medications, 2019
WFI, USP is defined within the U.S. Pharmacopeia as “…water purified by distillation or a purification process that is equivalent or superior to distillation in the removal of chemicals and microorganisms” and “…prepared from water complying with the U.S. Environmental Protection Agency National Primary Drinking Water Regulations or with the drinking water regulations of the European Union, Japan or with the World Health Organization’s Guidelines for Drinking Water Quality” (2). This water can contain no added substances and must meet the limits for TOC per USP <643>, conductivity per USP <645>, and bacterial endotoxins per USP <85>. WFI must be protected from microbial proliferation and monitored using suitable Action and Alert Levels to ensure control and use of only suitable quality water. WFI is intended for use in the preparation of parenteral solutions. The chemical purity requirements (both conductivity and TOC) for WFI are the same as those for PW; however, WFI must meet the added requirement for bacterial endotoxin. In addition, the recommended microbial Action and Alert Levels for WFI are 1,000-fold more stringent than for PW.
High-Purity Water
Published in Terry Jacobs, Andrew A. Signore, Good Design Practices for GMP Pharmaceutical Facilities, 2016
Distillation is one of the oldest water purification processes and has an extensive history in the production of pharmaceutical water. Distillation is the predominant process worldwide for production of WFI and is also used to produce PW and noncompendial waters. As stated earlier, distillation is the only process allowed by EuPhr for production of WFI. Distillation utilizes the phase change from liquid to vapor and removal of entrained liquid droplets to purify water. This process can, with appropriate pretreatment, reduce feed levels of ionized solids, suspended solids, organics, certain gases, microorganisms, and endotoxins to meet USP WFI and PW requirements.
A stepwise approach for identification of water production mechanisms in gas reservoirs
Published in Energy Sources, Part A: Recovery, Utilization, and Environmental Effects, 2021
Reza Abdollahi, Mahdi Nadri, Hasan Gholghanddashti, Mohsen Safari, Mohammadreza Zare Reisabadi
Another gateway in the current approach is layering and the existence of interbedded high permeable layer in reservoirs. A common problem with multilayer production occurs when a high-permeability zone with a flow barrier (such as a shale bed) above and below is watered out. Water crossflow can occur in high-permeability layers that are not isolated by impermeable barriers. When the problem occurs without crossflow, it can be easily treated by well-based methodologies. With crossflow, successful treatment is less likely because of crossflow away from the wellbore. The water source may be from an active aquifer or a water-flood injection well (Elphick and Seright 1997). If the reservoir does not have any interbedded high permeable layer, mechanism numbers 3 and 4 are not the probable cases.
Effect of glutamic acid elimination/substitution on the biological activities of S3 cationic amphiphilic peptides
Published in Preparative Biochemistry & Biotechnology, 2020
Mina Sepahi, Reza Ahangari Cohan, Shahin Hadadian, Dariush Norouzian
S3 peptide (HAEHKVKIGVEQKYGQFPQGTEVTYTCSGNYFLM) and its variants named S3E3A (E270A, E278A, E289A, and ΔM301) and S3E3 (ΔE270, ΔE278, ΔE289, and ΔM301) were synthesized and purified (purity >95%) by reverse-phase high-performance liquid chromatography (HPLC) (Bio Basic Inc., Canada). Peptides were diluted in sterile water for injection (WFI). Peptide concentrations were determined by measuring the optical density (OD) at λ280 nm using Nanodrop1000 (Thermo Fisher, USA). Extinction coefficients (0.1% w/v) of S3E3A, S3E3, and S3 peptides were calculated as 1.246, 1.325, and 1.149 ml.mg−1cm−1.[20] Molecular weights were determined by MS-ECI assay (Bio Basic, Canada). Mean hydrophobicity (<H>) was calculated according to the following equation[21] based on hydrophobicity scales of Fauchère.[22] where N is number of amino acids, and Hn is hydrophobicity scale of nth amino acid.
Assessment of occupational exposure to nebulized isopropyl alcohol as disinfectant during aseptic compounding of parenteral cytotoxic drugs in cleanrooms
Published in Journal of Occupational and Environmental Hygiene, 2021
Roland B. van den Berg, Stan de Poot, Eleonora L. Swart, Mirjam Crul
In this study, Klercide 70/30 IPA (Ecolab, Saint Paul, MN) was used as a disinfectant. Klercide 70/30 IPA is a mixture of 70% IPA and 30% water for injection. The MX6 iBrid (Industrial Scientific Corporation, Pittsburgh, PA) was used to measure the exposure to nebulized IPA. The MX6 iBrid is a six-gas monitor with a Photo Ionization Detector (PID) meter. The six-gas monitor can detect and measure vaporized concentrations of volatile organic compounds (VOCs), like IPA. Aerosols with IPA cannot be detected by the six-gas monitor. The signal for measuring IPA was not amplified or dampened by other VOCs, because no materials containing VOCs, besides IPA, are present in the cleanroom.