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Aseptic Manufacturing Facility Design
Published in Sandeep Nema, John D. Ludwig, Parenteral Medications, 2019
Mark Caldwell, Robert Helt, Beth Holden, Francesca McBride, Kevin Schreier
As defined by ISPE: An isolator is a leak-tight enclosure designed to protect operators from hazardous/potent processes or protect processes from people or detrimental external environments or both. A basic enclosure consists of a shell, viewing window(s), glove/sleeve assemblies, supply and exhaust filters, light (s), gauge (s), input and output openings (equipment door airlocks, Rapid Transfer Ports (RTPs), etc.), and various other penetrations. There are two types of isolators: Closed Isolators—Isolators operated as closed systems do not exchange unfiltered air or contaminants with adjacent environments. Their ability to operate without personnel access to the critical zone makes isolators capable of levels of separation between the internal and external environment unattainable with other technologies. Because of the effectiveness of this separation, closed isolators are ideally suited for application in the preparation of sterile and/or toxic material. Aseptic (to protect the product from operators\environment) and containment (to protect the operator from the product) isolators are two types of closed isolators.Open Isolators—Open isolators differ from closed isolators in that they are designed to allow for the continuous or semicontinuous movement of materials during operation, while maintaining a level of protection over the internal environment. Open isolators are decontaminated while closed, and then opened to start manufacturing. The inlet and outlets of the isolator are protected from the surrounding environment by overpressure, and potentially by external unidirectional air flow (UAF) units covering the openings, to ensure no contaminates can enter into the decontaminated Grade A\ISO 5 zone. Open isolators typically are used for the aseptic filling of finished pharmaceuticals, as components must be transferred into and out of the boundary (11). Both open and closed isolators utilize an automatic decontamination system. The system that is most commonly used is vaporized hydrogen peroxide (VHP). The typical procedure for VHP decontamination requires conditioning the environment to the desired temperature and relative humidity range, and then to vaporize the H2O2 on a hot plate or through atomization via a nozzle, and distribute it to the internal surfaces of the isolator. The system will inject additional doses to maintain a lethal concentration over a period of time to achieve the level of kill desired, typically in the range of 10−3 to 10−12 but usually 10−6. Once the kill is achieved, the VHP must be removed from the isolator via air intake\exhaust or thru the circulation over a catalyst until the required residual H2O2 is achieved. Note: Personal safety limit for 8-h exposure in the United States is 1.0 ppm and lower in other countries, but product sensitivity to oxidation from residual H2O2 must be evaluated as the exposure limit could be considerably lower.
Compatibility and efficacy of vaporised hydrogen peroxide technology to decontaminate reusable personal protective equipment
Published in Cogent Engineering, 2022
Daniela Rondinone, Tautvydas Karitonas, Enrico Allegra
Any decontamination technology that is being considered as a suitable option for the disinfection and reuse of PPE during future pandemic situations should be compatible with different types of PPE items to suit diverse user needs, as well as have solid quality assurance controls (Saini et al., 2020). A study by Thaper, Fagen & Oh reviewed the advantages and disadvantages of the following decontamination methods for their use on respiratory protection items: Ethanol; Ultraviolet germicidal irradiation (UVGI); Microwave-generated steam (MGS); Vaporized Hydrogen Peroxide (VHP); and Hydrogen peroxide gas plasma (HPGP). The analysis considered decontamination efficacy, respirator function, and feasibility. The authors reached the conclusion that Vaporised Hydrogen Peroxide (VHP) is the most promising method based on the high biocidal efficacy on FFRs and is also currently the most promising option for PAPRs since it shows the same efficacy as other technologies, but results in considerably less damage to the materials and components of the equipment (Thaper et al., 2021).
Medical textiles
Published in Textile Progress, 2020
Clearly, making possible the safe-reuse of respirators was not given an appropriate level of priority in some countries; certainly that was the case not only in the UK but also in Canada and the USA, however, the FDA by mid-April 2020 had issued several factsheets on decontamination of N95 respirators by various methods. These were put forward on the basis of “Emergency Use Authorisation (EUA)” [568]. The Stryker decontamination of compatible N95 respirators was approved using the Stryker Sterizone VP4 N95 Respirator Decontamination Cycle in the Sterizone VP4 Sterilizer (compatible N95 respirators are those that do not contain cellulose-based or paper materials, natural rubber, or latex). The device uses vaporised hydrogen peroxide as the decontaminant followed by ozone and this only enable decontamination for “single-user reuse up to two times” as was the case for the ASP STERRAD Sterilization, another hydrogen peroxide vapour system, whereas decontamination with the Sterilucent HC 80TT Vaporized Hydrogen Peroxide (VHP) Sterilizer allowed for a maximum of 10 decontamination cycles; a new EUA for Technical Safety Services LLC, Berkeley, CA. which allows decontamination and reuse 20 times was the latest to be issued at the time of writing. It is clear from outcomes such as these that blanket approval cannot be given for treatments simply because they make use of the sterilising effects of a particular agent or type of agent. It is the controlled application of the whole treatment procedure that is required to achieve the desired extent of reusability
Ambulance disinfection using Ultraviolet Germicidal Irradiation (UVGI): Effects of fixture location and surface reflectivity
Published in Journal of Occupational and Environmental Hygiene, 2018
William G. Lindsley, Tia L. McClelland, Dylan T. Neu, Stephen B. Martin, Kenneth R. Mead, Robert E. Thewlis, John D. Noti
Although terminal disinfection systems are increasingly popular for use in patient rooms in hospitals,[8] more information is needed about how well they work and how best to use them. The Centers for Disease Control and Prevention (CDC) recommends against the use of disinfectant fogging systems employing formaldehyde, phenol-based agents, or quaternary ammonium compounds in patient-care areas.[19] The CDC makes no recommendation regarding the use of systems based on hydrogen peroxide fogging, UVGI or ozone mists and says that more research is needed.[19,20] The Canadian Agency for Drugs and Technologies in Health (CADTH) also determined that insufficient evidence was available to make recommendations about terminal disinfection using vaporized hydrogen peroxide or UVGI.[21]