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Disinfection is a process of destruction of vegetative forms of pathogenic organisms which are capable of producing infection but not necessarily resistant spores ,on inanimate objects Disinfectants are germicides applied only to inanimate objects Antiseptics are germicides applied to living tissue and skin

 An ideal antiseptic or disinfectant should have following properties: Should have wide spectrum of activity Should be able to destroy microbes within practical period of time Should be active in the presence of organic matter Should make effective contact and be wettable Should be active in any pH Should be stable Should have long shelf life Should be speedy Should have high penetrating power Should be non-toxic, non-allergenic, non-irritative or non-corrosive Should not have bad odour Should not leave non-volatile residue or stain Efficacy should not be lost on reasonable dilution Should not be expensive and must be available easily

 Classification of disinfectants: 1. Based on consistency a. Liquid (E.g., Alcohols, Phenols) b. Gaseous (Formaldehyde vapor, Ethylene oxide) 2. Based on spectrum of activity a. High level b. Intermediate level c. Low level

 3. Based on mechanism of action a. Action on membrane (E.g., Alcohol, detergent) b. Denaturation of cellular proteins (E.g., Alcohol, Phenol) c. Oxidation of essential sulphydryl groups of enzymes (E.g., H2O2, Halogens) d. Alkylation of amino-, carboxyl- and hydroxyl group (E.g., Ethylene Oxide, Formaldehyde) e. Damage to nucleic acids (Ethylene Oxide, Formaldehyde)

Alcohol
Alcohol refers to two water-soluble chemical compounds
Ethyl alcohol Isopropyl alcohol

are rapidly bactericidal Tuberculocidal, Fungicidal,Virucidal Do not destroy bacterial spores Concentration
optimum bactericidal concentration is 60%90% solutions in water

 Mode of Action
denaturation of proteins.

Microbicidal Activity
Methyl alcohol (methanol) has the weakest bactericidal action

Ethyl alcohol
Pseudomonas aeruginosa was killed in 10 seconds with 30% to 100% (v/v), Serratia marcescens, E coli and Salmonella typhosa in 10 seconds with 40% to 100% Staphylococcus aureus and Streptococcus pyogenes in 10 seconds with 60%95%

 Ethyl alcohol potent virucidal agent at concentrations of 60% 80%,

lipophilic viruses (e.g., herpes, vaccinia, and influenza virus) hydrophilic viruses (e.g., adenovirus, enterovirus, rhinovirus, and rotaviruses but not hepatitis A virus (HAV) 58 or poliovirus)

Isopropyl alcohol is not active against the nonlipid enteroviruses but is fully active against the lipid viruses 95% Ethanol killed the Tubercle bacilli in sputum or water suspension within 15 seconds In 1964, Spaulding - alcohols were the germicide of choice for tuberculocidal activity, And they should be the standard by which all other compared

 Ethyl alcohol (70%) kills the tissue phase of Cryptococcus neoformans, Blastomyces dermatitidis, Coccidioides immitis, and Histoplasma capsulatum [<1 minute ] The culture phases of the latter three organisms aerosolized onto various surfaces [20 minutes ] Isopropyl alcohol (20%) is effective in killing the cysts of Acanthamoeba culbertsoni

 Uses To disinfect
Oral and Rectal thermometers Hospital pagers Scissors External surfaces of equipment (e.g., stethoscopes, ventilators, manual ventilation bags) CPR manikins , Ultrasound instruments Medication preparation areas.

 Disadvantages Flammable and consequently must be stored in a cool, well-ventilated area. They also evaporate rapidly, making extended exposure time difficult to achieve unless the items are immersed Not recommended for sterilizing medical and surgical materials principally because they lack sporicidal action and they cannot penetrate protein-rich materials

 Damage the shellac mountings of lensed instruments, Tend to swell and harden rubber and certain plastic tubing after prolonged and repeated use Bleach rubber and plastic tiles Damage tonometer tips (by deterioration of the glue) after the equivalent of 1 working year of routine use

 Tonometer biprisms soaked in alcohol for 4 days developed rough front surfaces that potentially could cause corneal damage; this appeared to be caused by weakening of the cementing substances used to fabricate the biprisms Corneal opacification has been reported when tonometer tips were swabbed with alcohol immediately before measurement of intraocular pressure

Chlorine , Chlorine Compounds

Hypochlorites, the most widely used of the chlorine disinfectants
liquid (e.g., sodium hypochlorite) solid (e.g., calcium hypochlorite).

household bleach- aqueous solutions of 5.25%6.15% sodium hypochlorite

 Advantages
Broad spectrum of antimicrobial activity, Do not leave toxic residues, Are unaffected by water hardness, Are inexpensive and fast acting , Remove dried or fixed organisms and biofilms from surfaces, Have a low incidence of serious toxicity.

 Mode of Action
Inactivation by Chlorine can result from a number of factors: Oxidation of sulfhydryl enzymes and amino acids; Ring chlorination of amino acids; Loss of intracellular contents; Decreased uptake of nutrients; Inhibition of protein synthesis; Decreased oxygen uptake; Oxidation of respiratory components; Decreased adenosine triphosphate production; Breaks in DNA; and depressed DNA synthesis. The actual microbicidal mechanism of chlorine might involve a combination of these factors or the effect of chlorine on critical sites

 Use
Inorganic chlorine solution is used for disinfecting tonometer heads Spot-disinfection of countertops and floors. A 1:10 1:100 dilution of 5.25%6.15% sodium hypochlorite For decontaminating blood spills
For small spills of blood (i.e., drops of blood) on noncritical surfaces, the area can be disinfected with a 1:100 dilution of 5.25%-6.15% sodium hypochlorite Because hypochlorites and other germicides are substantially inactivated in the presence of blood . large spills of blood require that the surface be cleaned before a 1:10 (final concentration) solution of household bleach is applied

 At least 500 ppm available chlorine for 10 minutes is recommended for decontaminating CPR training manikins Irrigating agent in endodontic treatment As a disinfectant for
manikins, laundry, dental appliances, hydrotherapy tanks , regulated medical waste before disposal , the water distribution system in hemodialysis centers and hemodialysis machines in water treatment

 Alternative compounds that release chlorine demandrelease chlorine dioxide, sodium dichloroisocyanurate, and chloramine-T. The advantage of these is that they retain chlorine longer and so exert a more prolonged bactericidal effect. Sodium dichloroisocyanurate tablets are stable, and for two reasons, the microbicidal activity might be greater than that of sodium hypochlorite solutions containing the same total available chlorine.
First, with sodium dichloroisocyanurate, only 50% of the total available chlorine is free (HOCl and OCl-), whereas the remainder is combined (monochloroisocyanurate or dichloroisocyanurate), and as free available chlorine is used up, the latter is released to restore the equilibrium.

 Second, solutions of sodium dichloroisocyanurate are acidic, whereas sodium hypochlorite solutions are alkaline, and the more microbicidal type of chlorine (HOCl) is believed to predominate

Chlorine dioxide-based disinfectants

prepared fresh by mixing the two components (base solution [citric acid with preservatives and corrosion inhibitors] and the activator solution [sodium chlorite]).

 A New Disinfectant: Superoxidized Water The concept of electrolyzing saline to create a disinfectant is appealing because the basic materials, saline and electricity, are cheap and the end product (water) is not damaging to the environment. A commercial adaptation of this process, Sterilox. The main products are hypochlorous acid at a concentration of approximately 144 mg/L and free chlorine radicals

 disinfectant is generated at the point of use by passing a saline solution over titanium-coated electrodes at 9 amps. The product generated has a pH of 5.0-6.5 and an oxidation reduction potential of >950 mV. Mode of Action. not clear but probably relates to a mixture of oxidizing species.

 Freshly generated superoxidized water is rapidly effective (<2 minutes) in achieving a 5-log10 reduction of pathogenic microorganisms (Mycobacterium tuberculosis, M. chelonae, poliovirus, HIV, MRSA, Escherichia coli, Candida albicans, Enterococcus faecalis, Pseudomonas aeruginosa) in the absence of organic loading. However, the biocidal activity was substantially reduced in the presence of organic material (5% horse serum) Additional studies are needed to determine if this solution may be used as an alternative to other disinfectants

Iodine
Its the halogen with highest atomic weight of the common halogens 3 types
Pure aqueous solutions
Topical Iodine solutions [2% Iodine +2.4%Sodium Iodide] Lugols solution [5%Iodine+10% Potassium Iodide]

Alcoholic solutions
Iodine tincture [2% Iodine + 2.4%Sodium Iodide in Aqueous Ethanol] Strong Iodine tincture [ 7% Iodine +5% Potassium Iodide in 95% Ethanol]

Iodophoric preparations [Povidone Iodine]

 The pure aqueous and alcoholic [Tincture Iodine] solution have largely been replaced by Idophors Since side effects
Staining Toxicity Irritation of tissues are far less

 Iodophors: is a combination of iodine and a solubilizing agent or carrier that has atleast 3 function
To increase the solubility of iodine provides a sustained-release reservoir of iodine To reduce the equilibrium concentration of free molecular iodine

Carriers are neutral polymers such as poly vinly pyrrolidinone ,poly ether glycols, polyvinly alcohols,polyacrylic acid, polyamides. They are used both as antiseptics and disinfectants

 Povidone-iodine :- 1 vinly -2 pyrrolidinone polymer with iodine which contains not less than 9% and not less than 12% available iodine Free Iodine contribute to the bactericidal activity of Idophors Dilutions demonstrate more rapid bactericidal action than does full strength Dilution might weaken the Iodine linkage to the carrier polymer with an accompanying increase of free iodine in solution . Therefore, Iodophors must be diluted according to the manufacturers' directions to achieve antimicrobial activity.

 Mode of Action.
Penetrate the cell wall of microorganisms quickly, The lethal effects are believed to result from disruption of protein and nucleic acid structure and synthesis.

Disadvantages
Staining Toxicity Irritation of tissues Should not be used on silicone catheters because they can adversely affect the silicone tubing .

 Uses: Antiseptic Disinfecting

Blood culture bottles and Medical equipment, such as
Hydrotherapy tanks, Thermometers, and Endoscopes.

Formaldehyde
Formaldehyde is used as a disinfectant and sterilant in both its liquid and gaseous states sold and used principally as a water-based solution called Formalin Used in concentration 40%[w/v] Formaldehyde gas dissolved in water constitutes a 100% solution of Formalin Mode of Action
by alkylating the amino and sulfhydral groups of proteins and ring nitrogen atoms of purine bases

 Uses.
As an embalming agent; to preserve anatomic specimens To prepare viral vaccines (e.g., poliovirus and influenza) To sterilize surgical instruments, especially when mixed with ethanol To disinfect disposable hemodialyzers reused on the same patient Aqueous formaldehyde solutions (1%2%) also have been used to disinfect the internal fluid pathways of dialysis machines

 Disadvantages Its irritating fumes and its pungent odor even at very low levels (<1 ppm). Suspected human carcinogen linked to nasal cancer and lung cancer Set an employee exposure standard for formaldehyde that limits an 8-hour time-weighted average exposure concentration of 0.75 ppm The standard includes a second permissible exposure limit in the form of a short-term exposure limit (STEL) of 2 ppm that is the maximum exposure allowed during a 15-minute period

 Long-term exposure to low levels in the air or on the skin can cause
Asthma-like respiratory problems And skin irritation, such as dermatitis and itching.

 Formaldehyde Gas: For sterilization of 1000 cu.ft of air space in a room ,50 ml Formalin [40%] is required After sealing the doors and windows of the room ,250gms of KMnO4 is added to 500ml formalin for every 1000 cu.ft [28.cu.metre] for generation of formaldehyde gas This gives vapour concentration of 2 mg gas per litre of air . Exposure time is 4 hrs

Glutaraldehyde
Glutaraldehyde is a saturated dialdehyde Aqueous solutions of glutaraldehyde are acidic and generally in this state are not sporicidal. Only when the solution is activated (made alkaline) by use of alkalinating agents to pH 7.5 8.5 does the solution become sporicidal. Once activated, these solutions have a shelf-life of minimally 14 days because of the polymerization of the glutaraldehyde molecules at alkaline pH levels. This polymerization blocks the active sites (aldehyde groups) of the glutaraldehyde molecules that are responsible for its biocidal activity.

 Novel Glutaraldehyde formulations e.g.,

Glutaraldehyde-phenol-sodium phenate, potentiated acid Glutaraldehyde, stabilized alkaline Glutaraldehyde produced in the past 30 years have overcome the problem of rapid loss of activity (e.g., use-life 2830 days) while generally maintaining excellent microbicidal activity

Used in the concentration of >2 %

FDA has cleared a GlutaraldehydePhenol/Phenate concentrate as a high-level disinfectant that contains 1.12% Glutaraldehyde with 1.93% Phenol/Phenate at its use concentration. Other FDA cleared sterilants that contain 2.4%3.4% are used undiluted

 Advantages
Noncorrosive action to endoscopic equipment, thermometers, rubber, or plastic equipment Excellent biocidal properties; activity in the presence of organic matter (20% bovine serum)

Mode of Action.
Alkylation of sulfhydryl, hydroxyl, carboxyl, and amino groups of microorganisms, which alters RNA, DNA, and protein synthesis.

 Uses.
High-level disinfectant for medical equipment such as Endoscopes Spirometry tubing, Dialyzers , transducers, Anesthesia ,respiratory therapy equipment , hemodialysis proportioning and dialysate delivery systems and reuse of laparoscopic disposable plastic trocars

 Disadvantages
Short shelf life Should not be used for cleaning noncritical surfaces because it is too toxic and expensive. Concentration decline after a few days of use in an automatic endoscope washer
Chemical test strips or liquid chemical monitors are available for determining whether an effective concentration of Glutaraldehyde is present despite repeated use and dilution. The frequency of testing should be based on how frequently the solutions are used (e.g., used daily, test daily; used weekly, test before use; used 30 times per day, test each 10th use), but the strips should not be used to extend the use life beyond the expiration date.

 Colitis caused by exposure from residual disinfecting solution in endoscope solution channels has been reported Keratopathy and corneal decompensation were caused by ophthalmic instruments that were inadequately rinsed after soaking in 2% Glutaraldehyde

 Acute or chronic exposure can result in

Skin irritation or dermatitis, Mucous membrane irritation (eye, nose, mouth), or Pulmonary symptoms . Epistaxis, Allergic contact dermatitis, Asthma, and Rhinitis also have been reported in healthcare workers exposed to Glutaraldehyde

Ortho-phthalaldehyde (OPA)
OPA solution is a clear, pale-blue liquid with a pH of 7.5. It contains 0.55% 1,2-Benzenedicarboxaldehyde (OPA). High-level disinfectant . Mode of Action. Like glutaraldehyde interact with amino acids, proteins, and microorganisms. However, OPA is a less potent cross-linking agent. This is compensated for by the lipophilic aromatic nature of OPA that is likely to assist its uptake through the outer layers of mycobacteria and gram-negative bacteria OPA appears to kill spores by blocking the spore germination process .

 Uses.
Transoesophageal echoprobes Automated endoscope reprocessor

Advantage
Several potential advantages over Glutaraldehyde. Excellent stability over a wide pH range (pH 39), Is not a known irritant to the eyes and nasal passages , Does not require exposure monitoring, Has a barely perceptible odor, And requires no activation.

 Disadvantage It stains protein gray Anaphylaxis-like reaction

Hydrogen Peroxide
Published reports ascribe good germicidal activity to hydrogen peroxide and attest to its bactericidal, virucidal, sporicidal, and fungicidal properties Mode of Action. works by producing destructive hydroxyl free radicals that can attack membrane lipids, DNA, and other essential cell components. Catalase, produced by aerobic organisms and facultative anaerobes that possess cytochrome systems, can protect cells from metabolically produced hydrogen peroxide by degrading hydrogen peroxide to water and oxygen. This defense is overwhelmed by the concentrations used for disinfection

 Uses. Commercially available 6% hydrogen peroxide is a stable and effective disinfectant when used on inanimate surfaces. It has been used in concentrations from 3% to 6% for disinfecting
soft contact lenses (e.g., 3% for 23 hrs) , tonometer biprisms ventilators , fabrics , and endoscopes.

 was effective in spot-disinfecting fabrics in patients rooms 3% Hydrogen Peroxide Solution is used for skin disinfection and deodorising wounds and ulcers. Disadvantages:
Decomposes in light, broken down by catalase, proteinaceous organic matter drastically reduces its activity.

Phenolics
Phenol has occupied a prominent place in the field of hospital disinfection since its initial use as a germicide by Lister in his pioneering work on antiseptic surgery In the past 30 years, however, work has concentrated on the numerous phenol derivatives or phenolics and their antimicrobial properties. Phenol derivatives originate when a functional group (e.g., alkyl, phenyl, benzyl, halogen) replaces one of the hydrogen atoms on the aromatic ring. Two phenol derivatives commonly found as constituents of hospital disinfectants are ortho-phenylphenol and orthobenzyl-para-chlorophenol.

 Phenol :
Pure Phenol/Carbolic acid is the best known member of this group Not effective disinfectant Used as a standard to compare the germicidal activity of disinfectants

Crude Phenol:
Mixture of phenol and cresol Dark oily liquid effect is greatly weakened by dilution [i.e not < 10%]

 Cresol :
3-10 times more powerful than Phenol yet no more toxic Best used in 5-10% strength

Cresol emulsions :
Cresol emulsified with soap is known as saponified Cresol ex:- Lysol, Izal, Cyllin etc. Lysol contains 50 -60 %Cresol

 Chlorhexidine:
One of the most useful skin antiseptics Soluble in water and alcohol Inactivated by soaps and detergents 0.5% alcoholic /aqueous can be used as effective hand lotions Creams and lotions containing 1% Chlorhexidine are recommended for burns and hand disinfection

Dettol [chloroxylenol]
is a relatively non toxic antiseptic and can be used safely in high concentrations more easily inactivated by organic matter Dettol [5%] is suitable for disinfection of instruments and plastic equipment with a contact of atleast 15 min

 Mode of Action. In high concentrations, phenol acts as a gross protoplasmic poison, penetrating and disrupting the cell wall and precipitating the cell proteins. Low concentrations of phenol and higher molecular-weight phenol derivatives cause bacterial death by inactivation of essential enzyme systems and leakage of essential metabolites from the cell wall .

Quaternary Ammonium Compounds

Are organically substituted ammonium compounds in which the nitrogen atom has a valance of 5 Four of the substituent radicals are alkyl or heterocyclic radicals of a given size or chain length The fifth is a halide ,sulfate or similar radical Each compound exhibits its own antimicrobial characteristics

 First generation benzalkonium chloride Second generation :- by substitution of the aromatic ring hydrogen with chlorine ,methyl and ethyl groups Third generation [dual quarts] mixture of 2 quaternary compound ex BTC 2125M
alkyl dimethyl benzyl ammonium and alkyl dimethyl ethyl benzyl ammonium chloride Had increased biocidal activity

 Fourth generation:- catalytic amination of long chain alcohols quaternized with methyl chloride ex dioctyl dimethyl ammonium bromide
Di decyl dimethyl ammonium bromide Out standing germicidal activity Unusual tolerance for anionic surfactants Protein loads Hard water Even low foaming

 Fifth generation :- twin chain quats

Dialkyl dimethyl ammonium chloride+benzalkonium chlorides [60:40]ratio

Sixth generation :- polymeric quaternary ammoniums are polyelectrolytes

Less toxic Less powerful Used in pharmaceuticals as preservatives

 Mode of Action.
inactivation of energy-producing enzymes, denaturation of essential cell proteins, and disruption of the cell membrane.

Uses. used in ordinary environmental sanitation of noncritical surfaces, such as floors, furniture, and walls. are appropriate to use for disinfecting medical equipment that contacts intact skin (e.g., blood pressure cuffs).

 Disadvantages
high water hardness and materials such as cotton and gauze pads can make them less microbicidal because of insoluble precipitates or cotton and gauze pads absorb the active ingredients, respectively. Gram negative bacteria can survive or grow in them Ex Pseudomonas

Surfacine
Surfacine is a new, persistent antimicrobial agent that may be used on animate or inanimate surfaces. It incorporates a water-insoluble antimicrobial compound (silver iodide) in a surface-immobilized coating (a modified polyhexamethylenebiguanide) Capable of chemical recognition and interaction with the lipid bilayer of the bacterial outer cell membrane by electrostatic attraction.

 The intimate microbial contact with the surface results in transfer of the antimicrobial component (silver) directly from the coating to the organism. Microorganisms contacting the coating accumulate silver until the toxicity threshold is exceeded; dead microorganisms eventually lyse and detach from the surface. The amount of silver present and the number of microorganisms in contact with the treated surface determine how long the coating is effective.

 Treated surfaces result in excellent elimination of antibiotic-resistant bacteria (e.g., VRE) inoculated directly on various surfaces at challenge levels of 100 CFU/sq inch for at least 13 days Demonstrate inactivation of bacteria, yeast, fungi, and viruses when the product is applied at challenge levels of up to106 CFU/mL.

 This persistent antimicrobial agent transfers the active biocide (silver) on demand directly to the organism without elution of silver ions into solution. Can be applied to animate and inanimate surfaces by dipping, brushing, or spraying without prior surface treatment The coating does not undergo photoreduction, degradation, or color change when exposed to intense UV irradiation . Has excellent adhesion to virtually all substrates, is optically clear, and does not delaminate, flake, or crack.

 Permanently treated surfaces remained chemically inert and retained their biocidal activity after exposure to various physical and chemical stresses such as temperature (tested from 20C to 130C), solvents (alcohol), solutions with a pH of 4 to 10, solutions of high ionic strength, and sterilization by conventional methods (e.g., steam, ethylene oxide, gamma irradiation). coated surfaces are resistant to biofilm formation. does not cause mammalian cell toxicity and passes the acute systemic toxicity tests

TESTING OF DISINFECTANTS
A disinfectant must be tested to know the required effective dilution
the time taken to effect disinfection and to periodically monitor its activity. As disinfectants are known to lose their activity on standing as well as in the presence of organic matter, their activity must be periodically tested.

 Different methods are: 1. Kochs method 2. Rideal Walker Method 3. Chick Martin test 4. Capacity use dilution test (Kelsey-Sykes test) 5. In-use test

 Rideal Walker method: This method relies on the estimation of phenol coefficient. Phenol coefficient of a disinfectant is calculated by dividing the dilution of test disinfectant by the dilution of phenol that disinfects under predetermined conditions. Both the phenol and the test disinfectant are diluted from 1/95 to 1/115 and their bactericidal activity is determined against Salmonella typhi suspension.

 Subcultures are performed from both the test and phenol at intervals of 2.5, 5, 7.5 and 10 minutes. The plates are incubated for 48-72 hours at 37C. That dilution of disinfectant which disinfects the suspension in a given time is divided by that dilution of phenol which disinfects the suspension in same time gives its phenol coefficient.

Disadvantages : No organic matter is included;

Salmonella typhi may not be appropriate; the time allowed for disinfection is short; it should be used to evaluate phenolic type disinfectants only.

 Chick Martin test: This test also determines the phenol coefficient of the test disinfectant. Unlike in Rideal Walker method where the test is carried out in water, the disinfectants are made to act in the presence of yeast suspension(or 3% dried human feces). Time for subculture is fixed at 30 minutes And the organism used to test efficacy is S.typhi as well as S.aureus. The phenol coefficient is lower than that given by Rideal Walker method

 Capacity use dilution test (Kelsey-Sykes test): Inoculum of four different test organisms, namely Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa and Proteus vulgaris are added to the disinfectant in three successive. Dried yeast is included to simulate presence of organic matter. The method can be carried out under 'clean' or 'dirty' conditions. The dilutions of the disinfectant are made in hard water for clean conditions and in yeast suspension for dirty conditions.

 Test organism alone or with yeast is added at 0,10 and 20 minutes interval. The contact time of disinfectant and test organism is 8 min. The disinfectant is evaluated on its ability to kill microorganisms or lack of it And the result is reported as a pass or a fail and not as a coefficient. The capacity test of Kelsey and Sykes gives a good guideline for the dilution of the preparation to be used. Disadvantage of this test is the fact that it is rather complicated.

 In-use test: The routine monitoring of disinfectant in use can be done by the in use test of Maurer. This test is intended to estimate the number of living organism in a vessel of disinfectant in actual use. The disinfectant that is already in use is diluted 1 in 10 by mixing 1 ml of the disinfectant with 9 ml of sterile nutrient broth. Ten drops of the diluted disinfectant (each 0.02 ml) is placed on two nutrient agar plates. One plate is incubated at 37C for 3 days while the other is held at room temperature for 7 days. The number of drops that yielded growth is counted after incubation. If there growth in more than five drops on either plate, it represents failure of disinfectant

Low-Temperature Sterilization
Two process are used for the sterilization of delicate,heat labile equipment Exposure to low temperature steam and formaldehyde Exposure to ethylene oxide

Formaldehyde Steam
Steam at subatmospheric pressures kills the spores of thermophilic bacteria very slowly Formaldehyde by itself is sporicidal but only at high concentrations and in the presence of moisture Together they appear to be synergistic Very low concentrations of Formaldehyde gas in the presence of subatmospheric steam will almost invariably kill spores

 Saturated steam at an absolute pressure of 263 mm Hg has a temperature of 73C which is accepted as standard for the process .

Loading : wash dry and warm the articles

Dont dry in an oven at a temperature above 60C Dont use metal containers . Load articles in the upright position to allow free drainage of condensate

 Sterilization cycle :
air removal and steam flush ,at an absolute pressure of about 50 mm Hg for about 20 min . Formaldehyde injection together with steam ,in a series of pulses each 5-10 min duration at an absolute pressure of 50-260 mm Hg A holding period at 71-75C for a minimum of1 hr at an absolute pressure of about 263 mm Hg Its evacuated by a steam flush and an air flush each of about 15 min duration at an absolute pressure of 50 760 mm Hg

 Testing :
The test organism is B. stearothermophilus

Toxicity :is toxic and irritates the eyes and respiratory tract at concentrations above 2 parts per million It can cause Allergic dermatitis Carcinogenic at irritant levels in rodents The permitted peak level of it in the environment is 2 p.p.m

Ethylene Oxide "Gas" Sterilization

Most commonly used process 2 types of
Mixed gas 100% ETO

Until 1995 ETO was mixed with a Chloroflouro -carbon [CCF] stabilizing agent in 12:88% Phased out in December 1995 Alternatives to CCF
100% ETO Carbon di oxide Hydrochlorofluorocarbons

 ETO is a colorless gas that is flammable and explosive. The four essential parameters (operational ranges) are:
gas concentration (450 to 1200 mg/l); temperature (37 to 63C); relative humidity (40 to 80%)(water molecules carry ETO to reactive sites); and exposure time (1 to 6 hours).

These influence the effectiveness of ETO sterilization.

 Mode of Action. The microbicidal activity of ETO is considered to be the result of Alkylation of protein, DNA, and RNA. Alkylation, or the replacement of a hydrogen atom with an alkyl group, within cells prevents normal cellular metabolism and replication

 Advantage:
the main advantage is that it can sterilize heat- or moisture-sensitive medical equipment without deleterious effects on the material used in the medical devices.

Disadvantages ETO are the lengthy cycle time, the cost, its potential hazards to patients and staff.

 The basic ETO sterilization cycle consists of five stages

i.e., preconditioning and humidification, gas introduction, exposure, evacuation, and air washes

and takes approximately 2 1/2 hrs excluding aeration time. Mechanical aeration for 8 to 12 hours at 50 to 60C allows desorption of the toxic ETO residual contained in exposed absorbent materials. Most modern ETO sterilizers combine sterilization and aeration in the same chamber as a continuous process. These ETO models minimize potential ETO exposure during door opening and load transfer to the aerator. Ambient room aeration also will achieve desorption of the toxic ETO but requires 7 days at 20C.

 Toxicity
. Exposure can cause
eye pain, sore throat, difficulty breathing and blurred vision. dizziness, nausea, headache, convulsions, blisters and vomiting and coughin.

demonstrated to be carcinogenic. has been linked to spontaneous abortion, genetic damage, nerve damage, peripheral paralysis, muscle weakness, and impaired thinking and memory. Occupational exposure in healthcare facilities has been linked to an increased risk of spontaneous abortions and various cancers. Injuries (e.g., tissue burns) to patients have been associated with ETO residues in implants used in surgical procedures. Residual ETO in capillary flow dialysis membranes has been shown to be neurotoxic in vitro.

 OSHA has established a PEL of 1 ppm airborne ETO in the workplace, expressed as a TWA for an 8-hour work shift in a 40-hour work week. The action level for ETO is 0.5 ppm, expressed as an 8-hour TWA, and the short-term excursion limit is 5 ppm, expressed as a 15-minute TWA

Hydrogen peroxide gas plasma

New sterilization technology based on plasma was patented in 1987 & marketed . Gas plasma have been referred to as fourth state of matter (liquids, solids, gases , gas of plasma) Gas plasma are generated in an enclosed chamber under deep vacuum using radio frequency or micro wave energy to excite the gas molecules & produce charged particles, many of which are in the form of free radicals.

 A free radical is an atom which as unpaired electron & is a highly reactive species. MECHANISM OF ACTION: By production of free radicals within a plasma field that are capable of interacting with essential cell components & thereby disrupt the metabolism of micro organisms. The type of seed gas used & the depth of vaccum are two important variables that can determine the effectiveness of the process

Procedure
The sterilization chamber is evacuated and hydrogen peroxide solution is injected from a cassette and is vaporized in the sterilization chamber to a concentration of 6mg/l . The hydrogen peroxide vapor diffuses through the chamber ( 50 min ) exposes all surfaces of the load to the sterilant and initiates the inactivation of microorganisms.

 An electrical field created by a radiofrequency is applied to the chamber to create a gas plasma. Microbicidal free radicals ( hydroxyl and hydro peroxyl) are generated in the plasma The excess gas is removed and in the final stage of the process the sterilization chamber is returned to atmospheric pressure by introduction of high efficiency filtered air.

 The by products of the cycle ( eg, water vapor, oxygen ) are non toxic and eliminate need for aeration . Thus the sterilized materials can be handled safely , either for immediate use or storage The process operates in the range of 37-44C and has a cycle time of 75 minutes.

 If any moisture is present on the objects the vaccum will not be achieved and the cycle aborts, A newer version of the unit improves sterilizer efficacy by using two cycles with a hydrogen peroxide diffusion stage and a plasma stage per sterilization cycle.

 This revision which is achieved by a software modification , reduces total processing time from 7352 minutes The manufacturers believes that the enhanced activity obtained with this system is due in part to the pressure Changes that occur during the injection and diffusion phases of the process.and to the fact that the process consists of 2 equal and consecutive half cycles each with a separate injection of hydrogen peroxide.

 This system and smaller version have received FDA 510[K] clearnce with limited application for sterilization of medical devices. The newest version of the unit which employes a new vaporization system that removes most of the water from the hydrogen peroxide , has a cycle time from 28-38 minutes Penetration of hydrogen peroxide vapors into long or narrow lumens has been addressed by the use of a diffusion enhancer.

 This is a small , breakable glass ampoule of concentrated hydrogen peroxide ( 50%) with an elastic connector that is inserted into the device lumen and crushed immediately before sterilization. The diffusion enhancer has been shown to sterilize bronchoscopes contaminated with mycobacteria tuberculosis. But it is not FDA cleared

Mode of action
This process inactivates microorganisms primarily by the combined use of hydrogen peroxide gas and the generation of the radicals ( hydroxyl and hydro peroxyl free radicals) during the plasma phase of the cycle.

 Uses. Materials and devices that cannot tolerate high temperatures and humidity, such as some plastics, electrical devices, and corrosion-susceptible metal alloys, can be sterilized by hydrogen peroxide gas plasma. This method has been compatible with most (>95%) medical devices and materials tested.