STERILIZATION AND CARE OF SURGICAL INSTRUMENTS Sterilization is a process used to destroy or eliminate viable microorganisms that may be present

in or on a particular product or package. The process requires an over all understanding and control of the preparation for use of all parts of the preparation for use of a particular product. Those areas include: The selection and acceptance of all materials used for the product and package. Environment in which the product is prepared. The final deposition of the remaining materials after use. The term sterilization in pharmaceutical preparation refers to the complete destruction of all living organisms and their spores or their complete removal from the preparation. Methods of sterilization There are five methods for sterilization of surgical instruments Steam sterilization Dry heat sterilization thermal method Sterilization by filtration Gas sterilization non-thermal method Sterilization by ionizing radiation. -methods used in attaining sterility in a pharmaceutical preparation are determined largely by the nature of the preparation and its ingredients. Thermal methods of sterilization The lethal effectiveness of heat on microorganisms depends on: The degree of heat The exposure period The moisture present - The time requires to produce a lethal effect is inversely proportional to the temperature employed. And the temperature required to sterilize a product is inversely related to the moisture present. A. Dry heat sterilization -substances that resist degradation at temperature above approximately 140oC may be rendered sterile by means of dry heat. Because dry heat is less effective in killing microorganisms than in moist heat, higher temperature and longer periods of exposure are required. - Individual units to be sterilized should be as small as possible and the sterilizer should be loaded in such a manner as to permit free circulation of heated air through out the chamber. - Dry heat sterilization has two targets: Destroy the ability of microorganisms to survive and multiply.

 Depyrogenation (destroy the chemical activity of microbial products/pyrogens. *sterilization: 160oC for 120-180 min 170oC for 90-120 min 180o C for 45- 60 min *depyrogenation: 230oC for 60-90 min 250oC for 30-60 min -if the sterilization period is long enough or the sterilization temperature is increased, the material will be pyrogen free in addition to being sterile. -This method is effective for few dry solids that are not affected adversely by high temperature and for relatively long heating period required. It used for substances that are not effectively sterilized by moist heat: fixed oils, glycerin, petrolatum, liquid petrolatum, paraffin, zinc oxide powder. It is used effective method for the sterilization of glass ware, metal ware and surgical instruments. B. Moist heat sterilization/ Saturated steam under pressure. -Steam sterilization is conducted in an autoclave and employs steam under pressure. -It is more effective than dry heat for thermal sterilization however that normal moist heat cycles do not destroy pyrogens. -When moisture is present, bacteria s are coagulated and destroyed at s considerably lower T0 than when moisture is absent. -Since it is not possible to raise the T0 of steam above 100oC under atmospheric conditions, pressure is employed to achieve higher To. But remember that it is the To not the pressure that have destructive effect on the MOs. -The application of the pressure is only for the purpose of increasing the To of the system. Eg. -10 pound pressure (115.5oC) for 30 min - 15 (121.5oC ) for 20 min - 20 (126.5oC ) for 15 min - The greater the pressure applied the higher the To attainable and the less the time required for sterilization -This method is an acceptable and effective method of sterilization for terminal sterilization, but the preparation must be sufficiently heat resistance to survive the procedure. Generally this method is the most comely used and the effective method for the sterilization of aqueous or substances the can be reached or penetrated by steam - The method is also applicable to bulk solutions, glass ware, surgical dressings and instruments -It is not useful in the sterilization of oils, fats, oleaginous preparation and other preparations not penetrated by the moisture or the sterilization of exposed powders that may be damaged by the condensed moisture. Non thermal method of sterilization A) Filtration sterilization -filtration may be used for the removal of particles including microorganisms from solutions and gases with out the application of heat. It is a process that removes but do not destroy microorganisms. - It used for the sterilization of heat sensitive/ thermo liable solutions.

-filters are composed of various materials such as sintered glass, porcelain, or fibrous materials (such as asbestos or cellulose)\ -the filtration mechanism of these filters is random adsorption of entrapment in the filter matrix. The disadvantages of those filters are: Low flow rate Difficulty in cleaning Media migration in to the filtrate -membrane filters have become the method of choice for sterilization of heat liable sterile products. They are thin, strong and homogenous polymeric structures. Microorganisms are removed by process of physical sieving and are retained on the membrane on the membrane surface. -membrane filters of 0.1 and 0.22 m pore size are employed commonly as sterilizing filters. -the membrane filtration equipment it self is sterilized as an assembly autoclaving. -after the filtration sterilization process all the steps (filling and sealing steps) should be carried out in an aseptic manner to avoid contamination the filtrate. B) Gas sterilization -Some heat sensitive and moisture sensitive materials can be sterilized much better by exposure to ethylene oxide or propylene oxide. These gases are highly flammable when mixed with air but can be employed safely when properly diluted with an inert gas such as carbon dioxide or fluorinated hydrocarbons. -sterilization with gas can be enhanced by increasing the relative humidity (moisture) and exposure temperature. -sterilization with ethylene oxide requires 4 to 16 hr of exposure. Ethylene oxide has sterilizing action by its interference with metabolism of the bacterial cell. - Ethylene oxide sterilization of pharmaceuticals is limited to dry powders. It has extensive application to sterilization of plastic materials, rubber goods, and delicate optical instruments. - It is found that stainless steel equipments have a longer useful life when sterilized with ethylene oxide instead of steam. -the effective penetrability of ethylene oxide makes it a useful sterilizing agent for parentral administration sets, hypodermic needles, plastic syringes, catheters. -ethylene oxide is also used to sterilize certain heat liable enzyme preparations, certain antibiotics and other drugs. It is not used in liquid pharmaceuticals b/c of the risk of alkylation with drug molecules in the liquid state. C) Radiation sterilization -sterilization by radiation may produce unwanted effects such as chemical changes in product components as well as changes in color or physical characteristics of package components. So the use of radiation for sterilization is in most cases limited to sterilization of materials such as plastic medical devices and ultraviolet light is commonly used to aid in the reduction of contamination in the air and on surfaces with in the processing environment.