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Page 22 of 29, , Carewell Pharma, SUBSCRIBE us on YOUTUBE, Page, , 15, , of 22, , They are disposable, single-use discs made up of, asbestos (magnesium trisilicate). It is supported on a perforated metal disc within a metal, funnel (Fig. 74). It is then fitted on to a sterile flask through a silicone rubber bung. The fluid, , (Asbestos filter (Seitz filter):, , to be sterilized is, put into the funnel and flask is connected to the exhaust pump. After, completion of fitration, the filter is discarded and the entire unit sterilized. The pore size of, , iters range from 0.01 to, , 5, , microns., , Sintefed glass filters (fritted glass filter/morton filters): Borosilicate glass is finely, , Powdered in a ball mill, , and packed into disc moulds and heated until suitable adhesion, , place between the granules. The sintered discs are finally fused into funnels of a, Sutable size, (Fig., 7.5). Sintered glass filters are available in several different, and shape, Takes, , Orosties but for filtration sterilization a number or grade 5 or 5 on 3 must be used. They, low adsorptive property and can be cleaned easily. They are brittle and expensive and, , a, , have a, , small area of filtration., , search CAREWELL PHARMA on YouTube, Watch Videos complete Syllabus wise
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Page 23 of 29, , Carewell Pharma, SUBSCRIBE us on YOUTUBE, Page 16 of 22, , Sintered dlsc, Funnel, , Asbestos pad, , (Flterlng medla), , Wing nut, , Perforated plate, , Fig.7.4: Seitz filter, , Fig. 7.5: Sintered glass filter, , These are manufactured in different, (ii) Filter candles (ceramic/Berkefield filter):, purification of water for industrial and, grades of porosity and have been used widely for, or kieselguhr. They are usual, drinking purposes. They are made of either porous porcelain, walls (Fig. 7.6). These are, encountered as cylindrical candles with comparatively thick, filters with cellular walls and are available in various sizes., , depth, , Fig.7.6: Filter candles, , The filter is fixed to the filter assembly and placed in a mantle. The liquid to be filtered is, poured into the mantle where vacuum forces it through the filter. After filteration, filter, candle is removed from the assembly and filterate istransferred toa sterile container., , These filters are inexpensive and available in different sizes. They are easily clogged, blocked and require high pressure for filtration., , search CAREWELL PHARMA on YouTube, Watch Videos complete Syllabus wise, , and
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Page 24 of 29, , Carewell Pharma, SUBSCRIBE us on YOUTUBE, Page 17 of 22, av) Membrane filter (millipore/ultra filter): These are made up of various types of, lklose and cellulose esters. They are 150 um thick and contain millions of microscopic, cellu, fro, pores ranging from 0.01 to 10 um in diameter. The pore sizes most often used for, rilization are 045 um t 0.02 pm (Millipore grade, HA) or 0.22, t 0.02 um (Millipore, steri, particularly, very, GS),, for, small bacterial contaminants. They are sterilized by, de,, utoclaving, in the holder or packed between thick flter pads to prevent curling. They are, 5o available at ready sterilised form (by ethylene oxide or ionizing radiation), Membrane, Fiters are supported on a rigid base of perforated metal, plastic or coarse sintered glass, Eia. 7.7). The HA grade filiters are approximately 65 ml/min./sq.cm. (GS 22 ml/min/sq.cm), with a differential pressure of 70 cm mercury across the membrane., , m, , -Funnel, Filter, , Filter holder, , -Cotton, To suction pump, , Flask, -Fltrate, , (a), , Components of filter, , (Sterile), , (b) Membrane filtration assembly, Fig. 7.7: Membrane filter, , Advantages of membrane filters, , are as follows, , microorganisms are separated by process of sieving., rate of filtration., 2 Membranes have a high and uniform porosity permitting a rapid, 3. Membranes are disposable. Hence, there is no cross contamination between filtered, 1, , All, , products., 4., , Adsorption is very less., Disadvantages of membrane filters are as follows:, , Prefilter is used before the membrane filter to avoid clogging and, , breaking., They have less chemical resistance to certain organic solvents such as chloroform,, ketones and esters., sterilization,, mbrane filters are routinely used in water purification and analysis,, sterility, also been, are, They, and for the preparation of solutions for parenteral use., d for the identification and enumeration of microorganisms from water samples ana, other materials., , search CAREWELL PHARMA on YouTube, Watch Videos complete Syllabus wise
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Page 27 of 29, , Carewell Pharma, SUBSCRIBE us on YOUTUBE, Page 20 of 22, , STERLT, , INDIGATORS, , that strict controls are carried out on products to be labelled 'sterile. Suc, controls must then ensure, the absence of viable microorganisms from these product, There are basically two types of controls:, It is essential, , L, , Controls on the process of sterilization ie. sterilization monitors or sterilization, indicators., , 2., , Sterility testing of the products., , Monitoring of the sterilization process can be achieved by the use of physical, chemic, or biological indicators of the sterilization performance., 1. Physical indicators:, , Moist heat: A master process record (MPR) is prepared as part of the validation, procedure for a particular autoclave and for each specified product and load, configuration. This may then be used as a reference for the process record, btained from a single thermocouple placed in a strategic part of each load (batd, process record, BPR). The MPR should be checked at, annual intervals and, whenever significant changes occur in the BPR when, compared with the MPR, Microprocessor, controlled sterilization cycles are now, a part of modem, autoclaves. Pressure is measured by pressure, gauges or through pressu, transducers, Dry heat: In dry heat sterilization, processes, a temperature, record chart is madeo, each sterilization cycle and is, compared against a master, temperature record., GD Radio sterilization: A, plastic dosimeter gives, an accurate measure of, dose absorbed and is considered, the radiatio", to, be, tl.2, best, technique, currently available, the radio sterilisation process., , 0), , Gaseous methods: For, gaseous, are monitored for each sterilizationsterilization procedures, elevated temperatu, cycle by temperature, probes and routine, , e, , search CAREWELL PHARMA on YouTube, Watch Videos complete Syllabus wise
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Page 28 of 29, , Carewell Pharma, SUBSCRIBE us on YOUTUBE, Page 21 of 22, , tests are performed to ensure gas-tight seals. Gas concentration is measurea, independently of pressure rise, often by reference to the weight of gas used., Pressure and humidity measurements are recorded., , (), , 2, , Filtration: Bubble point pressure test is a technique employed for determining the, pore size of filters and may also be used to check the integrity of certain types of, filter devices immediately after use. The principle of the test is that the filter is, soaked in an appropriate fluid and pressure is applied to the filter. The pressure, difference when the first bubble of air breaks away from the filter is equivalent to, the maximum pore size. When the air pressure is further increased slowly, there is, general eruption of bubbles over the entire surface. The pressure difference is, equivalent to the mean pore size., , Chemical indicators:, , Chemical monitoring of a sterlization process is based on the ability of heat, steam, a, sterilant gases and ionizing radiation to alter the chemical or physical characteristics of, variety of chemical substances., , Browne's tubes: The most commonly used chemical indicators for heat processes, are Browne's tubes. These are small sealed tubes containing a reaction mixture and, a, an indicator. Exposure to high temperature completes the reaction producing, change in the colour of the indicator (Table 7.5). All four types change from red, a, through yellow brown to green, the latter colour only being achieved after, specified time at the given temperature., Browne's, tube, , Table 7.5: Types of Browne's tubes, Temperature, Method of sterilization, (C), , ype, , Moist heat, , ype, , High vacuum moist heat, , ype II, ype IV, CGi), , Dry heat, , Colour of indicator, , 126, , Black spot, , 130 or more, , Yellow spot, , 160, , Green spot, , conveyor oven, 180, Blue spot, |Dry heat infra-red, Witness tubes: Witness tubes consist of single cnystalline substances of known, melting point contained in glass tubes e.g. sulphur (115 C), succinic anhydride, (120C), benzoic acid (121") etc. A dye may be included to show more clearly that, the crystals have melted. Such a device only indicates that a certain temperature, has been reached. Exposure time can be calculated by putting the crystals in one, end of an 'hour-glass' tube, the volume of the crystals and the diameter of the, constriction of the tube being adjusted so that the time for transfer of the melt is, the same as that required for the sterilisation at the required temperature., , search CAREWELL PHARMA on YouTube, Watch Videos complete Syllabus wise
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Page 29 of 29, , Carewell Pharma, SUBSCRIBE us on YOUTUBE, Page 22 of 22, , (i), , Heat-sensitive tape: Heat-sensitive tape is used quantitatively in the Bowie-Di, test. This is a test to determine that all air has been removed from dressings and, that subsequent steam penetration has been even and rapid. The tape is placed, suitably wrapped at the centre of a test pack. All the bars on the tape shoul, change colour to demonstrate full penetration of the steam., , (iv), , Royce sachet: The Royce sachet is a chemical indicator for ethylene oxide, sterlization. This consists of a polythene sachet containing magnesium chloride,, HCI and a bromophenol blue indicator. A given concentration-time exposure to, ethylene oxide results in the formation of ethylene chlorohydrin and a colour, change from yellow to purple., Chemical dosimeters: Chemical dosimeters give an accurate measure of the, radiation dose absorbed and are considered to be the best technique currently, available for controlling radiation sterilization. Qualitative indicatorsS made of, radiosensitive chemicals impregnated in plastic are also available. The indicator, changes from yellow to red during irradiation., , (v), , 3., , Biological indicators:, , are, Biological indicators consist of a suitable organism deposited on a carrier and, process, the units, distributed throughout the sterilizer load. At the end of the sterilization, survivors. The, are recovered and cultured to determine the presence or absence of, is able to integrate all, biological indicator measures sterilization processes directly and, reproducible, sterilization parameters. The selected organism should possess high and, and, characterizable, resistance to the sterilizing agent, should be genetically stable, readily, the, non-pathogenic. The viability of the organisms, the storage conditions before use and, The, incubation and culture conditions after sterilization must be standardized for the results., organisms used as biological indicators are usually resistant bacterial spores (Table 7.6)., processes, Table 7.6: Biological indicators formonitoringsterilization, Species, D-value, Sterilization process, Autoclave at 121°C, |Bacillusstearothermophilus 1.5 min, Clostridium sporogenes, 0.8 min, 160°C, Bacillus subtilis var. niger, Dry heat at, 5-10 min, Bacillus subtilis var. niger, 2.5 min, Ethylene oxide at 600 mg/lit., , Temperature, , 54 C, , 60%, , -, , relative, , humidity), Tonizing radiation, Membrane filter (0.45 um pore size), , Bacillus pumilus, Serratia marcescens, , Membrane filter(0.22 um poresize), , Pseudomonas diminuta, , search CAREWELL PHARMA on YouTube, Watch Videos complete Syllabus wise, , 3 kGy (0.3 M rad)