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Correct cooling practice is essential to maintain sterility. When a sterile item is not cooled in the correct manner the article can have moisture build up, which can contaminate stock. The item should be discharged if the packaging is torn, punctured or wet. Before any sterilized items is used it is necessary that the item be in the temperature range of 18-22ºC with relative humidity of 35-70%. In general this can be achieved with a cooling time of two hours however it does depend on the density of the item processed. AS 4187 recommends that at the end of the sterilization process, stock should be removed and inspected for signs of moisture. Sterile packs removed from a steam sterilizer should be cooled on a mesh surface to prevent the packaging from sweating. Do not place items on a solid surface or use forced cooling methods including fans or boosted air conditioning. If a plastic dust cover is to be applied, it needs to be applied after the sterile item has completely cooled. The equipment storage area must be free from dust, draughts, dampness and high traffic activity to minimise bioburden and environmental contamination. All sterile packages should be handled as little as possible to decrease risk of contamination.

Rejection of items intended to be sterile AS 4187 lists conditions under which a product is considered non-sterile. These may be summarised as items that: • are incorrectly wrapped • are damaged or opened • are still wet after the sterilizing cycle or comes into contact with a wet surface • have been placed or dropped on a dirty surface • have no indication of having been through a sterilizing process Disinfection & Sterilization Guidelines Queensland Health Version 2: November 2008 Page 13 of 16 Storage of sterile stock Immediately following sterilization, items should be minimally handled and stored in a low traffic area while cooling (refer AS 4187).

Three consecutive empty steam cycles are run with a biological and chemical indicator in an appropriate test package or tray. Each type of steam cycle used for sterilization (e.g., vacuum-assisted, gravity) is tested separately. In a prevacuum steam sterilizer three consecutive empty cycles are also run with a Bowie-Dick test. The sterilizer is not put back into use until all biological indicators are negative and chemical indicators show a correct end-point response811-814, 819, 958. Biological and chemical indicator testing is also done for ongoing quality assurance testing of representative samples of actual products being sterilized and product testing when major changes are made in packaging, wraps, or load configuration. Biological and chemical indicators are placed in products, which are processed in a full load. When three consecutive cycles show negative biological indicators and chemical indicators with a correct end point response, you can put the change made into routine use811-814, 958. Items processed during the three evaluation cycles should be quarantined until the test results are negative. Physical Facilities.

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The central processing area(s) ideally should be divided into at least three areas: decontamination, packaging, and sterilization and storage. Physical barriers should separate the decontamination area from the other sections to contain contamination on used items. In the decontamination area reusable contaminated supplies (and possibly disposable items that are reused) are received, sorted, and decontaminated. The recommended airflow pattern should contain contaminates within the decontamination area and minimize the flow of contaminates to the clean areas.

When a disinfectant is selected for use with certain patient-care items, the chemical compatibility after extended use with the items to be disinfected also must be considered. High-level disinfection traditionally is defined as complete elimination of all microorganisms in or on an instrument, except for small numbers of bacterial spores. The FDA definition of high-level disinfection is a sterilant used for a shorter contact time to achieve a 6-log10 kill of an appropriate Mycobacterium species. Cleaning followed by high-level disinfection should eliminate enough pathogens to prevent transmission of infection. 26, 27 Laparoscopes and arthroscopes entering sterile tissue ideally should be sterilized between patients. However, in the United States, this equipment sometimes undergoes only high-level disinfection between patients. 28-30 As with flexible endoscopes, these devices can be difficult to clean and high-level disinfect or sterilize because of intricate device design (e.g., long narrow lumens, hinges). Meticulous 10 Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 cleaning must precede any high-level disinfection or sterilization process. Although sterilization is preferred, no reports have been published of outbreaks resulting from high-level disinfection of these scopes when they are properly cleaned and high-level disinfected.

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Newer models of these instruments can withstand steam sterilization that for critical items would be preferable to high-level disinfection. Rinsing endoscopes and flushing channels with sterile water, filtered water, or tap water will prevent adverse effects associated with disinfectant retained in the endoscope (e.g., disinfectant-induced colitis). Items can be rinsed and flushed using sterile water after high-level disinfection to prevent contamination with organisms in tap water, such as nontuberculous mycobacteria, 10, 31, 32 Legionella, 33-35 or gram-negative bacilli such as Pseudomonas.

For this reason, it is necessary to do a proper setting due to the properties of the product that will be sterilized. c. Necessity of optimum system The decrease in the efficiency of the sterilization, change in the color and the strength depend on the excess dose. Another disadvantage of the excess energy or dose is the significant increase in the costs. It is also important to notice that the higher energy is generally 10 MeV. Obtaining a uniform dose to objects with a sufficient e-beam energy is important for the construction of optimum irradiation system (25). THE USE OF E-BEAM STERILIZATION IN THE INDUSTRY AND ITS COMPARISON WITH OTHER STERILIZATION TECHNIQUES Sterile product defined by European Pharmacopoeia and Committee for Proprietary Medicinal Products is the pharmaceutical dosage form that is sterilized in its terminal phase. The choise of sterilization method depends on the product that will be sterilized, the sensitivity of microorganisms to that sterilization method and the sterilization dose, the desired SAL value and the sensitivity of the product to the radiation (28). The use of e-beam sterilization in pharmaceutical industry This procedure is especially important for products which have a complex formulation and packaging process.

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Steam indicator class 6

Sterilization equipments

This is because, it is hard to do any validation for these complex sterile products under aseptic conditions and is also hard to maintain aseptic conditions in every single stage. Terminal sterilization is better for maintaining and assuring the sterility of pharmaceuticals and medical devices. The only drawback of it is its high costs depending on the need to develop huge irradiation institutions. However, many drug companies use terminal sterilization methods for maintaining safety and effectiveness to the FDA’s satisfaction, a costly and time consuming activity.