Introduction Sterilization can be defined as any process that effectively kills or eliminates transmissible agents (such as fungi, bacteria

, viruses and prions) from a surface, equipment, foods, medications, or biological culture medium. In practice sterility is achieved by exposure of the ob ect to be sterilized to chemical or physical agent for a specified time. !arious agents used as steriliants are" elevated temperature, ionizing radiation, chemical liquids or gases etc. #he success of the process depends upon the choice of the method adopted for sterilization. Pharmaceutical Importance of Sterilization $% &oist heat sterilization is the most efficient biocidal agent. In the pharmaceutical industry it is used for" Surgical dressings, Sheets, Surgical and diagnostic equipment, 'ontainers, 'losures, (queous in ections, )phthalmic preparations and Irrigation fluids etc. *% +ry heat sterilization can only be used for thermo stable, moisture sensitive or moisture impermeable pharmaceutical and medicinal. #hese include products like, +ry po-dered drugs, Suspensions of drug in non aqueous solvents, )ils, fats -axes, soft hard paraffin silicone, )ily in ections, implants, ophthalmic ointments and ointment bases etc. .% /aseous sterilization is used for sterilizing thermolabile substances like, hormones, proteins, various heat sensitive drugs etc. 0% 1.! light is perhaps the most lethal component in ordinary sunlight used in sanitation of garments or utensils. 2% /amma3rays from 'obalt 45 are used to sterilize antibiotic, hormones, sutures, plastics and catheters etc. 4% 6iltration sterilizations are used in the treatment of heat sensitive in ections and ophthalmic solutions, biological products, air and other gases for supply to aseptic areas. #hey are also used in industry as part of the venting systems on fermentors, centrifuges, autoclaves and freeze driers. &embrane filters are used for sterility testing. !ariables that affect sterilization include" $. #he dryness of devices to be processed *. #he temperature and humidity of the processing area .. 7hether or not the devices -ere properly prepared and loaded into the sterilizer 0. 7hether or not the sterilizing agent is properly delivered into the system 2. #he sterilizer8s condition and maintenance protocol 4. 7hether or not the correct sterilization method and cycle -ere used Terms commonly used Survivor curves #hey are plots of the logarithm of the fraction of survivors (microorganisms -hich retain

.viability follo-ing a sterilization process) against the exposure time or dose.

the exposure time and the presence of -ater. hydrolysis and denaturation occur. 6or radiation and heat treatment. involving destruction of enzymes and other essential cell constituents. In the presence of -ater much lo-er temperature time exposures are required to kill microbe than in the absence of -ater. 6iltration method 'hemical &ethod $. oxidative changes take place. Z-value . /aseous method *.3value represents the increase in temperature needed to reduce the +3value of an organism by 95:. thus lo-er heat input is required.. Heat Sterilization =eat sterilization is the most -idely used and reliable method of sterilization. >adiation method . depending upon the temperature employed. =ot air oven It employs higher temperatures in the range of $453$?55' and requires exposures time up to * hours. #he action of heat -ill be due to induction of lethal chemical events mediated through the action of -ater and oxygen. a. but it can be used 5 for moisture3sensitive materials for -hich dry heat ($453$?5 ') sterilization. #he benefit of dry heat includes good penetrability and non3corrosive nature -hich makes it applicable for sterilizing glass-ares and . In this processes both dry and moist heat are used for sterilization. #his method of sterilization can be applied only to the thermostable products.. +3value is the time taken at a fixed temperature or the radiation dose required to achieve a 95: reduction in viable count. 1nder dry state. #hermal (=eat) methods *. <hysical &ethod $. >ed heat . 6laming 0. Dry Heat Sterilization @xamples of +ry heat sterilization are" $.05') sterilization is used. and higher heat input is required. Incineration *. Methods of Sterilization #he various methods of sterilization are" $. #he process is more effective in hydrated state -here under conditions of high humidity. $.Expression of resistance D-value +3value is indicative of the resistance of any organism to a sterilizing agent. and for moisture3 resistant materials for -hich moist heat ($*$3$. #he efficiency -ith -hich heat is able to inactivate microorganisms is dependent upon the degree of heat.

a layer of air may form at the bottom of the autoclave. Steam under pressure is used to generate high temperature needed for sterilization. )ven may be pre3heated for materials -ith poor heat conductivity. media. and reagents. #his method of sterilization -orks -ell for many metal and glass items but is not acceptable for rubber. (n insulated chamber surrounded by an outer case containing electric heaters. check the drain screen at the bottom of the chamber and clean if blocked. -hich consists of the follo-ing" $) *) . .0 5'. =ot -ater belo. preventing efficient operation. Steam for sterilization can be either -et saturated steam (containing entrained -ater droplets) or dry saturated steam (no entrained -ater droplets). Before using the autoclave.boiling point &oist heat sterilization involves the use of steam in the range of $*$3$. and equipment that -ould be damaged by high temperatures (6igure $). (utoclaves should be tested periodically -ith biological indicators like cultures of Bacillus stearothermophilus to ensure proper function.) 0) (rticles to be sterilized are first -rapped or enclosed in containers of cardboard.Moist Heat Sterilization &oist heat may be used in three forms to achieve microbial inactivation $. #hen. b. Boiling -aterC steam at atmospheric pressure .. 5 #he temperature is allo-ed to fall to 05 '.metal surgical instruments. the materials are arranged to ensure uninterrupted air flo-. Saturated steam (steam in thermal equilibrium -ith -ater from -hich it is derived) acts as an effective sterilizing agent. (utoclaves use pressurized steam to destroy microorganisms. ( fan Shelves #hermocouples #emperature sensor +oor locking controls. 6or efficient heat transfer. Hot-air oven +ry heat sterilization is usually carried out in a hot air oven. paper or aluminum. It is also used for sterilizing non3aqueous thermostable liquids and thermostable po-ders. If the sieve is blocked -ith debris. +ry saturated steam A (utoclaving *. prior to removal of sterilized material. plastics. and are the most dependable systems available for the decontamination of laboratory -aste and the sterilization of laboratory glass-are. steam must flush the air out of the autoclave chamber. +ry heat destroys bacterial endotoxins (or pyrogens) -hich are difficult to eliminate by other means and this property makes it applicable for sterilizing glass bottles -hich are to be filled aseptically.) 0) 2) 4) !peration $) *) .

$" (n (utoclave (utoclaves.) 0) 2) 4) ( cylindrical or rectangular chamber. -ith capacities ranging from 055 to ?55 liters.6ig. or steam sterilizers essentially consist of follo-ing" $) *) . #hermometer or temperature gauge <ressure gauges !peration 6or porous loads (dressings) sterilizers are generally operated at a minimum temperature of . 7ater heating system or steam generating system Steam outlet and inlet valves Single or double doors -ith locking mechanism.

#he concentration ranges (-eight of gas per unit chamber volume) are usually in range of ?553 $*55 mgCD for ethylene oxide and $23$55 mgCD for formaldehyde -ith operating temperatures of 0234. #he stages of operation of autoclaves include air removal. holdingCexposure. =. amino. and cooling stages). Both of these gases being alkylating agents are potentially mutagenic and carcinogenic.E' and F53F2E' respectively. @thylene oxide is a colorless. and for bottled fluid. hydroxyl and carboxyl groups on proteins and amino groups of nucleic acids. and flammable gas. sterilizers employing a minimum temperature of $*$ ' are used. @nsure that there should be sufficient -ater in the autoclave to produce the steam. odorless. "aseous Sterilization #he chemically reactive gases such as formaldehyde. steam admission and sterilization cycle (includes heating up. 5 5 . (methanol.'=)) and ethylene oxide ('=*)*) possess biocidal activity.0 '. #he mechanism of antimicrobial action of the t-o gases is assumed to be through alkylations of sulphydryl.$. #hey also produce acute toxicity including irritation of the skin. con unctiva and nasal mucosa.

$# Hydro. *. #his agent sterilizes by oxidizing key cellular components.553Ditre capacity and surrounded by a -ater acket. #he appropriate trayCcontainer must then be selected. #he sterilant concentrate is provided in a sealed single3 use cup and requires no pre3mixing or dilution. It -as also found to be -ater soluble. the appropriate connector attached. -hich inactivates the microorganisms. and left no residue after rinsing. It -as also sho-n to have no harmful health or environmental effects. $# %o& temperature steam formaldehyde '%TS() sterilizer (n D#S6 sterilizer operates -ith sub atmospheric pressure steam. In a lo-3temperature liquid chemical sterile processing system. %i*uid Sterilization a# Peracetic +cid li*uid sterilization <eracetic acid -as found to be sporicidal at loconcentrations. Deak testing is done to ensure there are no leaks that could allo. (fter treatment. air is removed by evacuation and steam is admitted to the chamber. @thylene oxide gas has been used -idely to process heat3sensitive devices. #he temperature of this sterilization method is maintained in the 05325E' range. -ater vapor and oxygen are formed. #he disadvantages of this method of sterilization are that the devices must be immersible. several steps must be follo-ed for effective sterilization" $. the gases are evacuated either directly to the outside atmosphere or through a special exhaust system. -hich makes it particularly -ell3suited for use -ith heat3sensitive and moisture3sensitive medical devices. . then evacuation is done again and preheated vaporized ethylene oxide is passed. #he instruments are -rapped prior to sterilization.a# Ethylene oxide sterilizer (n ethylene oxide sterilizer consists of a chamber of $553. resulting in no toxic residues and harmful emissions.en Peroxide Sterilization #his method disperses a hydrogen peroxide solution in a vacuum chamber. 0. 7hen the energy source is turned off. but the aeration times needed at the end of the cycle to eliminate the gas made this method slo-. creating a plasma cloud. humidification and conditioning of the load is done by passing sub3atmospheric pressure steam. and can either be stored or used immediately. must fit in the appropriate tray. #he plasma cloud exists only -hile the energy source is turned on. It disrupts bonds in proteins and enzymes and may also interfere -ith cell membrane transportation through the rupture of cell -alls and may oxidize essential enzymes and impair vital biochemical path-ays. . and if the device has lumens. <re3cleaning of the devices is necessary because many devices have small connected lumens.fluid to enterCleak the ampoulesCvials and cause damage. (ir is removed from sterilizer by evacuation. (t first. and must be able to -ithstand the 22E' temperature the process uses..

prostheses. particulate radiation (e.#here are five phases of the hydrogen peroxide processing cycle" $.g. 0. But some undesirable changes occur in irradiated products. >adiation sterilization is generally applied to articles in the dry state. stripping the electrons from some of the molecules and producing a lo-3temperature plasma cloud. accelerated electrons) . #his phase lasts about *5 minutes. . plastic syringes and dry pharmaceutical products. . . 6ollo-ing this reaction. for treatment of manufacturing grade -ater. for surface sterilization of aseptic -ork areas. ( vacuum phase creates a vacuum in the chamber and the pressure drops to less than one pound per square inch.. +uring the diffusion phase the hydrogen peroxide vapor spreads throughout the chamber and the increased pressure drives the sterilant into the packs. +uring the plasma phase the radio frequency energy is applied. ( mercury lamp giving peak emission at *20 nm is the suitable source of 1! light in this region. and poor penetrability finds uses in the sterilization of air. unit dose ointments. each rod carefully arranged -ithin the source and containing *5 H'i of activity. including surgical instruments. 2.g. *. 1! light.#he ma or target for these radiation is microbial +G(. a# "amma ray Sterilizer /amma rays for sterilization are usually derived from cobalt345 source. sutures. -ith its much lo-er energy. #his source is housed -ithin a reinforced concrete building -ith * m thick -alls. -adiation Sterilization &any types of radiation are used for sterilization like electromagnetic radiation (e. >adiation sterilization -ith high energy gamma rays or accelerated electrons has proven to be a useful method for the industrial sterilization of heat sensitive products. gamma rays and 1! light). but is not suitable for sterilization of pharmaceutical dosage forms. (rticles being sterilized are passed through the irradiation chamber on a conveyor belt and move around the raised source. the isotope is held as pellets packed in metal rods. It lasts about one minute. /amma rays and electrons cause ionization and free radical production -hile 1! light causes excitation.ltraviolet Irradiation #he optimum -avelength for 1! sterilization is *45 nm. the aqueous hydrogen peroxide is introduced into the vacuum chamber and is vaporized into a gas. #he purpose of the venting phase is to introduce filtered air into the chamber and return the chamber to atmospheric pressure so that the door can be opened. -hich creates a rise in pressure due to the increase of molecules. exposing the instrument surfaces to the sterilant and killing the microorganisms. an example is aqueous solution -here radiolysis of -ater occurs. the activated compounds lose their high energy and recombine to form oxygen and -ater. In the in ection phase.

and polyvinylidene fluoride.$ mm thick.** micrometer nominal pore diameter are generally used. micrometer in diameter.9F: of particles I5. the electrostatic accelerator -hich produces electrons -ith maximum energies of 2 &e!. #he merits.#he membranes are supported on a frame and held in special holders. autoclaves and freeze driers. &embrane filters are used for sterility testing. -hich is the ratio of the number of organism challenging the filter under defined conditions to the number of organism penetrating it. or some other synthetic material. ( high energy electron beam is generated by accelerating electrons from a hot filament do-n an evacuated tube under high potential difference. #he factors -hich affects the performance of filter is the titre reduction value. biological products and air and other gases for supply to aseptic areas. (rticles to be sterilized are arranged on a horizontal conveyor belt and are irradiated from one or both sides. centrifuges. #hey are also used in industry as part of the venting systems on fermentors. made of cellulose acetate. demerits and applications of different methods of sterilization are given in #able $.. unglazed porcelain filter. viscous fluids and organic solvents. adsorption and trapping -ithin the matrix of the filter material. and then additional energy is imparted to this beam in a pulsed manner by a synchronized traveling micro-ave. #here are t-o types of filters used in filtration sterilization ($) Depth filters 'onsist of fibrous or granular materials so packed as to form t-isted channels of minute dimensions. . #he performance of =@<( filter is monitored by pressure differential and airflo. (ir is first passed through prefilters to remove larger particles and then passed through =@<( filters. (iltration Sterilization 6iltration process does not destroy but removes the microorganisms. It is used for both the clarification and sterilization of liquids and gases as it is capable of preventing the passage of both viable and non viable particles. Sterilizing grade filters are used in the treatment of heat sensitive in ections and ophthalmic solutions. =igher energies cause better penetration into the product but there is a risk of induced radiation. #hey are made of diatomaceous earth. #he other factors are the depth of the membrane.Electron +ccelerator #here are t-o types of electron accelerator machines. +pplication of filtration for sterilization of . its charge and the tortuosity of the channels. and the micro-ave linear accelerator -hich produces electrons -ith maximum energies of $5 &e!.rate measurements.ases =@<( (=igh efficiency particulate air) filters can remove up to 99. cellulose nitrate. sintered glass or asbestos. 6luids are made to transverse membranes by positive or negative pressure or by centrifugation. (*) Mem$rane filters #hese are porous membrane about 5. #he ma or mechanisms of filtration are sieving. +pplication of filtration for sterilization of li*uids &embrane filters of 5. polycarbonate. but sintered filters are used for corrosive liquids.

media. prostheses.Ta$le / Merits0 Demerits and +pplications of Different Methods of Sterilization Methods =eat sterilization Mechanism +estroys bacterial endotoxins Merits &ost -idely used and reliable method of sterilization. Demer its 'an be applied only to the thermostable product s +pplication s +ry heat is applicable for sterilizing glass-ares and metal surgical instruments and moi heat is st the most dependable method for decontamination of laboratory -aste and the sterilization of laboratory glass-are. .an exampl e is aqueou s solutio -her n e radioly sis of -ater occurs. >adiation sterilization is generally applied to articles in the dry state. @thylene oxide gas use has been d -id ely to process heat3 sensitive devices. including surgical instruments. and reagents. unit dose /aseous sterilization (lkylation <enetrati ng ability of gases /ases being alkylati ng agents are potentially mutagenic and carcinogenic 1ndesirable change occu s r in irradiated products. sutures. >adiation sterilization Ionization of nucleic acids It is a useful method for the industrial sterilization of heat sensitive products. involving destruction of enzymes and other essential cell constituents.

6iltration sterilization +oes not destroy but removes the microorganisms It is used both clarificati on and sterilizati on liquids fo r th e +oes not differentiate bet-een viable and non viable particle s ointments. . plastics #his method is Sterilizing grade filters are used in the treatment of heat sensitive in ections and ophthalmic solutions. of an d gases as it is capable of preventin th g e passage of both viable no and n viable particles. biological products and air and other gases for supply to aseptic area s.

Sign up to vote on this title
UsefulNot useful

Master Your Semester with Scribd & The New York Times

Special offer: Get 4 months of Scribd and The New York Times for just $1.87 per week!

Master Your Semester with a Special Offer from Scribd & The New York Times