Introduction Many chemical substances toxic to m/organisms. Very limited numbers used as sterilizing agents.

zing agents. Example of gaseous sterilants: --Ethylene oxide (mostly used) Formaldehyde (LTSF) Hydrogen peroxide Gas Plasma Peracetic acid Gluteraldehyde Ozone Chlorine dioxide Propylene oxide

4. Concentration & temp ranges (wt of gas per unit chamber): Ethylene oxidex800-1200mg/L (45-63oC) Formaldehydex15-100mg/L (70-75oC) Sterilization process lengthy even at higher temp: Not suitable for re-sterilization of highturnover articles. Need to remove toxic residues of gaseous. Extended quarantine period (sterility tests). Alkylating agents: mutagenic carcinogenic may cause: i. Acute toxicity -via inhalation -symptoms- irritation of skin, nasal mucosa,conjunctiva). ii. Chronic toxicity -due to chronic expousure -symptoms-neurological,ocular,haematological #therefore, its important to control [ATM] develops safe working protocols

Ethylene oxide and formaldehyde; 1. Broad spectrum biocidal activity 2. Applications in sterilization of ; Re-usable surgical instruments. Medical, diagnostic & electrical equipments Surface of powders. Disposable medical devices (alternative to radiation). 3. Do not offer the same degree of sterility assurance as heat sterilization. 4. Reserved for heat-sensitive items Mechanism of antimicrobial action: 1. Alkylation of sulphydryl, amino, hydroxyl & carboxyl groups on protein & imino groups of nucleic acids. 2. At concentration employed in sterilization, type A survivor curve produced. 3. Lethality increasing in non-uniform manner with increasing concentration, exposure temp & humidity.

Ethylene oxide
Highly explosive in mixture of >3.6% v/v in air. Thus, supplied for sterilization as: 10% mix with CO2 8.6% mixture with HFC 124 Pure ethylene oxide gas used below ATM pressure in sterilizer chamber (all air must be removed). Normally used to sterilize: Dressings Catheters Infusion & giving sets Syringes Prostheses Some plastic containers & closures Some thermolabile powders (if humidity is not a problem) Used to sterilize surfaces. Cannot penetrate through many walls of many containers to the products inside. x sterilize sealed vials or ampoules of liquid products. x penetrate certain plastic films & bags. Factors affecting efficacy of ethylene oxide as sterilant: Concentration of the gas Temperature (50-60 Gas pressure Humidity (some moisture must be present, activity declined when in excess)x30-70%. Time of exposure Gas distribution & penetration Rubber, plastic, fabric & paper Drawback: level of ethylene oxide in sterilizer lower due to absorption during the process & treated articles must undergo desorption stage to remove toxic residues.

Formaldehyde (LTSF)
Formaldehyde gas: heating formalin (37% w/v aqueous solution of formaldehyde) temp of 70-75 oC to(or 60-80oC) with steam . Formaldehyde + steam= LTSF (low temp steam & formaldehyde) Toxicity = ethylene oxide Absorption to materials lower but = desorption routine recommended. Widely used to disinfect clean rooms. Also has been used for sterilization of range of medical devices. Major disadvantagexx penetrating powerx limit packaging materials that can be employed: Paper Cotton fabric

Hydrogen peroxide gas plasma

Alternatives to ethylene oxide and formaldehyde sterilization. Advantages: Non-toxic (by-productx water, oxygen). Desorption unnecessary. Shorter cycle time. Sterilized items can be safely used/stored immediately. Gas plasma: 4th state of matter. Gas plasma produced under following conditions to excite gas molecules & produce charged particles: Enclosed chamber Deep vacuum Radio frequency / microwaves energy Mode of antimicrobial activity: Free radicals produced (hydroxyl & hydroperoxyl) interact with essential cell components (i.e. enzymes, nucleic acids)x disrupt metabolisms broad antimicrobial activity including resistant bacterial spore Applications of H2O2 gas plasma sterilization include: Medical & surgical devices Plastics Electrical devices Corrosion susceptible metal alloys Most commonly used plasma sterilizer known as STERRAD Operating tempx40-50oC. Operating cyclex45-70 mins (or even lesser!) Uses combination of H2O2 vapor + low temp gas plasma. Operated under low moisture environment. Sterilization process occurs in the following order: 1. Item placed in the chamber, chamber closed, vacuum drawn. 2. Aqueous solution of H2O2 injected into chamber & vaporized, surrounding items to be sterilized. 3. After a period of H2O2 diffusion, chamber pressure low, thus low temp. 4. Radio frequency (RF) applied to create electric field and form low temp gas plasma. 5. In the plasma state H2O2 break apart to produce reactive species including free radicals. 6. Combination of H2O2 vapor + plasma kill the organisms and sterilized the items. 7. Following reaction, highly reactive species lose their energy and recombine to form non-toxic by products. 7. When process completed, RF energy turnedoff. 8. Vacuum released, ATM pressure restored by admission of filtered air into the chamber. 9. Items sterilized and ready for use.

function

to
sterilize the loads.thus, necessary to include biological indicators in each load #cycles used have included: 250 mg/L -1500 mg/L (gas concentration) 30% - 90% (relative humidity) 30oC - 65oC (temperature) 1hr 30hr (exposure time) #sterilization cycle !

Ethylene oxide Sterilizer design

-proof stainless -300 L. Surrounded by hot-water jacketx provide uniform chamber temp. Successful operation involved: Product loading according to predefined configuration. Removal of air from chamber by evacuation. Humidification & conditioning of load by passage of sub-ATM pressure steam. Followed by further evacuation period & admission of pre-heated vaporized ethylene oxide from external pressurized canisters/single charged cartridges. Forced gas circulationx minimize variations in conditions throughout chamber. Internal fan External re-circulation loop Packaging materials: Air, steam, gas permeable to permit suitable conditions for sterilization. Absorption of ethylene oxide by load compensated for by introduction of excess gas as pressure drops during sterilization process. At the beginning. Once the pressure drop during the process. moisture absorption Addition of water to maintain appropriate relative humidity. After treatment, gases are evacuated: Directly to outside ATM or, Via special exhaust system. Then, filtered, sterile air admitted for: Repeat of vacuum/air cycle. Air purging until chamber is opened. Safe removal of ethylene oxide achieved, reducing toxic,hazard to the operator. Sterilized articles removed directly from chamber & arranged for desorption: Naturally on open shelves:takes days to complete Assisted by special forced aeration cabinet where flowing, heated air encourages gas removal (2-24 hr). Operation of ethylene oxide sterilizerx automatically controlled & monitored.

Formaldehyde (LTSF)
LTSF sterilizer: designed to operate with sub-ATM pressure steam. Air removal (evacuation), and Steam admission to chamber: Allow heating of load. Assist in air removal. Sterilization period starts with release of formaldehyde by vaporization from formalin (in vaporizer in steam jacket). Continued with either: Simple holding stage. Series of pulsed evacuation & steam and formaldehyde admission cycles. Chamber temp maintained through: Thermostatically controlled water-jacket. Steam & condensate removal via drain channel & evacuated condenser. At the end of treatment period: Formaldehyde vapor expelled by steam flushing. Load dried by alternating stages of evacuation & admission of sterile, filtered air.

Hydrogen peroxide gas plasma