Sterilization autoclave

Sterile filtration, with subsequent aseptic filling, is common because of the heat sensitivity of many drugs. Those drug solutions that can withstand heat should be terminally autoclave sterilized after filling, since this best assures product sterility. 

The exact identity of all packaging components, the bulk and filled product, labels, and so on, must be carefully maintained. The production ticket must be written so that it is easily understood and followed by the appropriate production personnel. All procedures should be clearly outlined and limits established for all operators (e.g., heat water to 35 45°C or autoclave sterilize for 15-20 min at 121-124°C). 

Surgical and dental instruments (up to 3000 autoclave sterilization cycles)... Endoscope components. .. 

Machines with direct impact on product quality (autoclaves, sterilizing units, labeling system, weighing system, production control system, facility control system, etc.)... 

Their resistance to autoclave sterilization makes them useful for medical instruments and trays. Other uses are microwave cookware, coffee decanters, and corrosion-resistant piping. 

The most common sterilization processes are gaseous ethylene oxide (EtO), gamma radiation, and autoclave sterilization. The resistance of adhesives to these processes will be dependent on the conditions of the sterilization cycle as well as on the chemistry of the adhesive. 

Autoclave sterilization is one of the most difficult common sterilization environments for a medical adhesive, and it is commonly used in hospitals and health care facilities for reusable devices. Autoclaves sterilize with high-pressure steam. Temperatures inside the sterilization chamber typically can reach 130°C with pressures above ambient. Certain adhesive systems, such as polyurethanes, may show hydrolytic degradation in such environments especially after multiple cycles. Epoxies perform the best under multiple autoclave exposures. However, on certain substrates, light-cured acrylics and cyanoacrylates will also perform fairly well. 

To get a better idea of how to formulate the nanosized emulsion delivery systems suitable for parenteral, ocular, percutaneous, and nasal uses, the reader is referred to more detailed descriptions of methods of nanosized emulsion preparation [6, 116], A hot-stage high-pressure homogenization technique or combined emulsification technique (de novo production) is frequently employed in order to prepare nanosized emulsions with desired stability even after subjection to autoclave sterilization. Therefore, the steps involved in this technique in making blank anionic and cationic emulsions were arranged in the following order ... 

Polyethersulfone compositions, (1), having high heat tolerance, good impact resistance, and Tg s greater than 235°C were prepared by Brunelle [1] and used as trays in steam autoclave sterilization units and as microwave cookware. Johnson [2] determined that the impact strength of this composition was greater than the commercially available polyethersulfone, RADEL . 

Currently, thermoplastics account for less than 5% of the elastomeric closures for parenterals. Their limited resistance to heat deformation imder stress during autoclave sterilization is the main reason for this limited use. However, thermoplastics have two advantages over thermosets. First, they are chemically less complex and therefore less prone to interact with parenteral medications, and second, they may be manufactured by a simpler and more automated process. Thermoplastic elastomers have found use in baby bottle nipples and dropper bulbs that are not typically heat sterilized under compression. 

Metal instruments Ethylene oxide Autoclave Sterilization Dry heat Cutting edges should be protected from mechanical damage during the... 

Rubber gloves Ethylene oxide Autoclave Sterilization Gamma-radiation If autoclave used, care should be taken with drying at end of process. Little... 

Respirator parts Ethylene oxide Moist heat (autoclave) Sterilization Sterilization by dry Chemicals not recommended may be... 

In heat sterilization processes, a temperature record chart is made of each sterilization cycle with both dry and moist heat (i.e. autoclave) sterilizers this chart forms part of the batch documentation and is compared against a master temperature record (MTR). It is recommended that the temperature be taken at the coolest part of the loaded sterilizer. Further information on heat distribution and penetra-... 

Autoclave-sterilized flat end toothpicks or metal inoculating loop. 

Autoclaved sterile toothpicks or inoculating needles (cat 08-757-135, Fisher Scientific, Pittsburgh, PA). 

Autoclave sterilization consists of exposing the parts to steam in a pressurized vessel. Temperatures of 121 °C to 132 °C at pressures up to 2 atmospheres are reached with saturated moisture. Under these conditions, some polymer materials hydrolyze and revert to monomers with loss of adhesive strength. Materials most susceptible to reversion include some polyurethanes, acryUcs, and silicones. Epoxies are most resistant. 

A double-doored autoclave is provided for decontaminating materials that leave the facility. The autoclave door which opens to the area external to the facility is automatically controlled so that it can only be opened afterthe autoclave sterilization cycle is completed. 

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