An autoclave is a machine used to carry out industrial and scientific processes requiring elevated temperature and pressure in relation to ambient pressure and/or temperature. Autoclaves are used before surgical procedures to perform sterilization and in the chemical industry to cure coatings and vulcanize rubber and for hydrothermal synthesis. Industrial autoclaves are used in industrial applications, especially in the manufacturing of composites.
Sterilization autoclaves are widely used in microbiology and mycology, medicine and prosthetics fabrication, tattooing and body piercing, and funerary practice. They vary in size and function depending on the media to be sterilized and are sometimes called retort in the chemical and food industries.
A notable recent and increasingly popular application of autoclaves is the pre-disposal treatment and sterilization of waste material, such as pathogenic hospital waste. Machines in this category largely operate under the same principles as conventional autoclaves in that they are able to neutralize (but not eliminate) potentially infectious agents by using pressurized steam and superheated water. A new generation of waste converters is capable of achieving the same effect without a pressure vessel to sterilize culture media, rubber material, gowns, dressings, gloves, etc. It is particularly useful for materials that cannot withstand the higher temperature of a hot air oven.[8]
Autoclaves are also widely used to cure composites, especially for melding multiple layers without any voids that would decrease material strength, and in the vulcanization of rubber.[9] The high heat and pressure that autoclaves generate help to ensure that the best possible physical properties are repeatable. Manufacturers of spars for sailboats have autoclaves well over 50 feet (15 m) long and 10 feet (3 m) wide, and some autoclaves in the aerospace industry are large enough to hold whole airplane fuselages made of layered composites.[10]
It is very important to ensure that all of the trapped air is removed from the autoclave before activation, as trapped air is a very poor medium for achieving sterility. Steam at 134 C (273 F) can achieve a desired level of sterility in three minutes, while achieving the same level of sterility in hot air requires two hours at 160 C (320 F).[11] Methods of air removal include:
Stovetop autoclaves used in poorer or non-medical settings do not always have automatic air removal programs. The operator is required to manually perform steam pulsing at certain pressures as indicated by the gauge.[12]
Autoclaves are found in many medical settings, laboratories, and other places that need to ensure the sterility of an object. Many procedures today employ single-use items rather than sterilizable, reusable items. This first happened with hypodermic needles, but today many surgical instruments (such as forceps, needle holders, and scalpel handles) are commonly single-use rather than reusable items (see waste autoclave). Autoclaves are of particular importance in poorer countries due to the much greater amount of equipment that is re-used.[citation needed]
Because damp heat is used, heat-labile products (such as some plastics) cannot be sterilized this way or they will melt. Paper and other products that may be damaged by steam must also be sterilized another way. In all autoclaves, items should always be separated to allow the steam to penetrate the load evenly.
Autoclaving is often used to sterilize medical waste prior to disposal in the standard municipal solid waste stream. This application has become more common as an alternative to incineration due to environmental and health concerns about the combustion by-products emitted by incinerators, especially from the small units which were commonly operated at individual hospitals. Incineration or a similar thermal oxidation process is still generally mandated for pathological waste and other very toxic or infectious medical waste. For liquid waste, an effluent decontamination system is the equivalent hardware.
In most of the industrialized world medical-grade autoclaves are regulated medical devices. Many medical-grade autoclaves are therefore limited to running regulator-approved cycles. Because they are optimized for continuous hospital use, they favor rectangular designs, require demanding maintenance regimens, and are costly to operate. (A properly calibrated medical-grade autoclave uses thousands of gallons of water each day, independent of task, with correspondingly high electric power consumption.)
Autoclaves used in education, research, biomedical research, pharmaceutical research and industrial settings (often called "research-grade" autoclaves) are used to sterilize lab instruments, glassware, culture media, and liquid media. Research-grade autoclaves are increasingly used in these settings where efficiency, ease-of-use, and flexibility are at a premium. Research-grade autoclaves may be configured for "pass-through" operation. This makes it possible to maintain absolute isolation between "clean" and potentially contaminated work areas. Pass-through research autoclaves are especially important in BSL-3 or BSL-4 facilities.
In 2016, the Office of Sustainability at the University of California, Riverside (UCR) conducted a study of autoclave efficiency in their genomics and entomology research labs, tracking several units' power and water consumption. They found that, even when functioning within intended parameters, the medical-grade autoclaves used in their research labs were each consuming 700 gallons of water and 90 kWh of electricity per day (1,134MWh of electricity and 8.8 million gallons of water total), because they consumed energy and water continuously, even when not in use. UCR's research-grade autoclaves performed the same tasks with equal effectiveness, but used 83% less energy and 97% less water.[17]
In order to sterilize items effectively, it is important to use optimal parameters when running an autoclave cycle. A 2017 study performed by the Johns Hopkins Hospital biocontainment unit tested the ability of pass-through autoclaves to decontaminate loads of simulated biomedical waste when run on the factory default setting. The study found that 18 of 18 (100%) mock patient loads (6 PPE, 6 linen, and 6 liquid loads) passed sterilization tests with the optimized parameters compared to only 3 of 19 (16%) mock loads that passed with use of the factory default settings.[18]
There are physical, chemical, and biological indicators that can be used to ensure that an autoclave reaches the correct temperature for the correct amount of time. If a non-treated or improperly treated item can be confused for a treated item, then there is the risk that they will become mixed up, which, in some areas such as surgery, is critical.
To prove sterility, biological indicators are used. Biological indicators contain spores of a heat-resistant bacterium, Geobacillus stearothermophilus. If the autoclave does not reach the right temperature, the spores will germinate when incubated and their metabolism will change the color of a pH-sensitive chemical. Some physical indicators consist of an alloy designed to melt only after being subjected to a given temperature for the relevant holding time. If the alloy melts, the change will be visible.[20]
Some computer-controlled autoclaves use an F0 (F-nought) value to control the sterilization cycle. F0 values are set for the number of minutes of sterilization equivalent to 121 C (250 F) at 103 kPa (14.9 psi) above atmospheric pressure for 15 minutes. Since exact temperature control is difficult, the temperature is monitored, and the sterilization time adjusted accordingly.[21]
Best of all, they protect wrapped trays from any sharp edges that might tear wrap when trays are loaded or unloaded. Liners come in three standard sizes to fit both floor loaded and shelf loading autoclaves.
Of all the methods available for sterilization, moist heat in the form of saturated steam under pressure is the most widely used and the most dependable. Steam sterilization is nontoxic, inexpensive 826, rapidly microbicidal, sporicidal, and rapidly heats and penetrates fabrics (Table 6) 827. Like all sterilization processes, steam sterilization has some deleterious effects on some materials, including corrosion and combustion of lubricants associated with dental handpieces212; reduction in ability to transmit light associated with laryngoscopes828; and increased hardening time (5.6 fold) with plaster-cast 829.
The two basic types of steam sterilizers (autoclaves) are the gravity displacement autoclave and the high-speed prevacuum sterilizer. In the former, steam is admitted at the top or the sides of the sterilizing chamber and, because the steam is lighter than air, forces air out the bottom of the chamber through the drain vent. The gravity displacement autoclaves are primarily used to process laboratory media, water, pharmaceutical products, regulated medical waste, and nonporous articles whose surfaces have direct steam contact. For gravity displacement sterilizers the penetration time into porous items is prolonged because of incomplete air elimination. This point is illustrated with the decontamination of 10 lbs of microbiological waste, which requires at least 45 minutes at 121C because the entrapped air remaining in a load of waste greatly retards steam permeation and heating efficiency.831, 832 The high-speed prevacuum sterilizers are similar to the gravity displacement sterilizers except they are fitted with a vacuum pump (or ejector) to ensure air removal from the sterilizing chamber and load before the steam is admitted. The advantage of using a vacuum pump is that there is nearly instantaneous steam penetration even into porous loads. The Bowie-Dick test is used to detect air leaks and inadequate air removal and consists of folded 100% cotton surgical towels that are clean and preconditioned. A commercially available Bowie-Dick-type test sheet should be placed in the center of the pack. The test pack should be placed horizontally in the front, bottom section of the sterilizer rack, near the door and over the drain, in an otherwise empty chamber and run at 134C for 3.5 minutes.813, 819 The test is used each day the vacuum-type steam sterilizer is used, before the first processed load. Air that is not removed from the chamber will interfere with steam contact. Smaller disposable test packs (or process challenge devices) have been devised to replace the stack of folded surgical towels for testing the efficacy of the vacuum system in a prevacuum sterilizer.833 These devices are "designed to simulate product to be sterilized and to constitute a defined challenge to the sterilization process."819, 834 They should be representative of the load and simulate the greatest challenge to the load.835 Sterilizer vacuum performance is acceptable if the sheet inside the test pack shows a uniform color change. Entrapped air will cause a spot to appear on the test sheet, due to the inability of the steam to reach the chemical indicator. If the sterilizer fails the Bowie-Dick test, do not use the sterilizer until it is inspected by the sterilizer maintenance personnel and passes the Bowie-Dick test.813, 819, 836
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