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Carewell PharmaSUBSCRIBE us on YOUTUBE
Muh (Advauragu)
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NoF Sutabl for har Jaleilu substac,which Canmo u1h stand hlatnq a
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RovGDIeGRAM
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(Asbestos filter (Seitz filter): 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
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 adhesionTakes place between the granules. The sintered discs are finally fused into funnels of a
Sutable size and shape (Fig. 7.5). Sintered glass filters are available in several differentOrosties but for filtration sterilization a number or grade 5 or 5 on 3 must be used. They
a lowadsorptive property and can be cleaned easily. They are brittle and expensive andhave a small area of filtration.
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Sintered dlsc
FunnelAsbestos pad(Flterlng medla)
Wing nut
Perforated plate
Fig. 7.5: Sintered glass filterFig.7.4: Seitz filter
(ii) Filter candles (ceramic/Berkefield filter): These are manufactured in different
grades of porosity and have been used widely for purification of water for industrial and
drinking purposes. They are made of either porous porcelain or kieselguhr. They are usual
encountered as cylindrical candles with comparatively thick walls (Fig. 7.6). These are depth
filters with cellular walls and are available in various sizes.
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 and
blocked and require high pressure for filtration.
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av) Membrane filter (millipore/ultra filter): These are made up of various types of
cellulklose and cellulose esters. They are 150 um thick and contain millions of microscopic
steri
pores ranging fro
rilization are 045 um t 0.02 pm (Millipore grade, HA) or 0.22 m t 0.02 um (Milliporede, GS), particularly for very small bacterial contaminants. They are sterilized by
from 0.01 to 10 um in diameter. The pore sizes most often used for
utoclaving, in the holder or packed between thick flter pads to prevent curling. They are5o 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 glassEia. 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.
-Funnel
Filter
Filter holder-Cotton
To suction pump
Flask-Fltrate (Sterile)
(a) Components of filter (b) Membrane filtration assembly
Fig. 7.7: Membrane filter
Advantages of membrane filters are as follows
1 All microorganisms are separated by process of sieving.
2 Membranes have a high and uniform porosity permitting a rapid rate of filtration.
3. Membranes are disposable. Hence, there is no cross contamination between filtered
products.
4. Adsorption is very less.Disadvantages of membrane filters are as follows:
Prefilter is used before the membrane filterto avoid clogging and breaking.
They have less chemical resistance to certain organic solvents such as chloroform,
sterilityand for the preparation of solutions for parenteral use. They are also been
ketones and esters.
mbrane filters are routinely used in water purification and analysis, sterilization,
d for the identification and enumeration of microorganisms from water samples anaother materials.
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E
Sunuivina pach'm (No. of backua)
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Temperatua (°c)
2
i N
:
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STERLT INDIGATORS
It is essential 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:
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, chemicor biological indicators of the sterilization performance.
1. Physical indicators:
Moist heat: A master process record (MPR) is prepared as part of the validationprocedure for a particular autoclave and for each specified product and loadconfiguration. 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 (batdprocess record, BPR). The MPR should be checked at annual intervals andwhenever significant changes occur in the BPR when compared with the MPRMicroprocessor controlled sterilization cycles are now a part of modemautoclaves. Pressure is measured by pressure gauges or through pressutransducersDry heat: In dry heat sterilization processes, a temperature record chart ismadeoeach sterilization cycle and is compared against a master temperature record.GD Radio sterilization: A plastic dosimeter gives an accurate measure of the radiatio"dose absorbed and is considered to be tl.2 best technique currentlyavailablethe radio sterilisation process.
0) Gaseous methods: For gaseous sterilization procedures, elevated temperatuare monitored for each sterilization cycle by temperature probes and routinee
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tests are performed to ensure gas-tight seals. Gas concentration is measureaindependently of pressure rise, often by reference to the weight of gas used.Pressure and humidity measurements are recorded.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 offilter 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 pressuredifference when the first bubble of air breaks away from the filter is equivalent tothe 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.
2 Chemical indicators:
Chemical monitoring of a sterlization process is based on the ability of heat, steamsterilant gases and ionizing radiation to alter the chemical or physical characteristics of a
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
an indicator. Exposure to high temperature completes the reaction producing a
change in the colour of the indicator (Table 7.5). All four types change from red
through yellow brown to green, the latter colour only being achieved after a
specified time at the given temperature.
Table 7.5: Types of Browne's tubes
Colour of indicatorTemperature(C)
Method of sterilizationBrowne'stube
ype Moist heat 126 Black spot
ype High vacuum moist heat 130 or more Yellow spot
ype II Dry heat 160 Green spot
ype IV |Dry heat infra-red conveyoroven 180 Blue spotCGi) 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 thatthe crystals have melted. Such a device only indicates that a certain temperaturehas been reached. Exposure time can be calculated by putting the crystals in oneend of an 'hour-glass' tube, the volume of the crystals and the diameter of theconstriction 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.
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(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.
(v) 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.
3. Biological indicators:
Biological indicators consist of a suitable organism deposited on a carrier and are
distributed throughout the sterilizer load. At the end of the sterilization process, the units
are recovered and cultured to determine the presence or absence of survivors. The
biological indicator measures sterilization processes directly and is able to integrate all
sterilization parameters. The selected organism should possess high and reproducible
resistance to the sterilizing agent, should be genetically stable, readily characterizable and
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. The
organisms used as biological indicators are usually resistant bacterial spores (Table 7.6).
Table 7.6: Biological indicators formonitoringsterilization processes
Sterilizationprocess Species D-value
|BacillusstearothermophilusClostridium sporogenes
Bacillus subtilis var. nigerBacillus subtilis var. niger
1.5 min
0.8 min
5-10 min
2.5 min
Autoclave at 121°C
Dry heat at 160°C
Ethylene oxide at 600 mg/lit.
Temperature 54 C 60% - relative
humidity)Tonizing radiation
Membrane filter (0.45 um pore size)
Bacillus pumilus
Serratia marcescens3 kGy (0.3 M rad)
Membrane filter(0.22 um poresize) Pseudomonas diminuta
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