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Steam Sterilization in Autoclaves
Published in James Agalloco, Phil DeSantis, Anthony Grilli, Anthony Pavell, Handbook of Validation in Pharmaceutical Processes, 2021
The validation of steam sterilization in autoclaves constitutes perhaps the most-studied validation problem faced by the pharmaceutical industry. Indeed, it was failure to sterilize certain large-volume parenteral solutions that resulted in several patient deaths in the early 1970s, prompting the United States Food and Drug Administration (FDA) to call for the “validation” of sterilization processes. Because of this, autoclave sterilization was the first validation program undertaken by the industry. This requirement soon spread to other pharmaceutical processes. Sterilization in autoclaves remains a universal issue in nearly all facilities where sterile operations occur and continues to be of paramount concern to both the industry and the various international drug regulatory agencies.
Design inputs: Part II
Published in Marie B. Teixeira, Design Controls for the Medical Device Industry, 2019
Many medical devices are provided sterile or require sterilization prior to use or reuse. As a result, you need to identify the sterilant or sterilization method and any associated parameters. For example, if sterilization is to be performed using radiation, then the radiation dose needs to be indicated. If sterilization is to be performed using ethylene oxide (EtO), then the maximum levels of EtO residuals that may remain on the device needs to be indicated. If sterilization is to be performed using moist heat (e.g., autoclave), then the configuration (e.g., gravity displacement or pre-vacuum), temperature, and time need to be indicated. The sterility assurance level (SAL) should also be indicated. An SAL of 10−6 is expected for most devices unless the device is intended only for contact with intact skin. FDA recommends an SAL of 10–3 for devices that only come into contact with intact skin.
Inactivation of Staphylococcus aureus in Surgical Needles by Exposure to Ozone Gas and Low Pressure
Published in Ozone: Science & Engineering, 2023
Vera Lúcia Taba, Henrique Cunha Carvalho, Túlia de Souza Botelho, Adriana Barrinha Fernandes, Carlos José de Lima, Antonio Balbin Villaverde
Sterilization by ionizing radiation, such gamma rays, is considered the gold standard and offers many advantages over conventional steam or EtO processes and does not present any of the toxicological problems of the EtO sterilization due to solvent residues that can remain in the sterilized material. Thoroughly aerated surgical and medical items that have been sterilized in the EtO sterilizer, such as polyvinyl chloride tube, require 12 hours at 50 °C and 8 hours at 60 °C, before using these items in patient care (Kumar 2012). Gamma radiation sterilization is used on a large scale by manufacturers of surgical instruments, enabling the supply of sterile instruments already packaged. However, it is more expensive than other sterilization methods due to the need for large facilities (Arias et al. 2020; Singh, Singh, and Singh 2016).
Manufacturing, use phase or final disposal: where to focus the efforts to reduce the environmental impact of a food machine?
Published in Production & Manufacturing Research, 2022
Roberta Stefanini, Bricoli Barbara, Giuseppe Vignali
The beverage system considered in the study is an aseptic blowing-filling system: it consists of an aseptic rotary blow molding machine with an aseptic integrated filler and capper. The principle is to sterilize the preforms with Vaporized Hydrogen Peroxide (VHP) technology, then blow them with sterile air, in a sterile environment, and maintain sterility throughout the filling and capping processes, in which also caps are sterilized with H202. The estimated annual productivity is 110 million bottles. The life cycle of the machine is 15 years.