Category Archives: News about Autoclave Sterilizer

News about Autoclave Sterilizer

Key Performance Indicators Pressure Steam Sterilization Of Medical Devices

Key Performance Indicators Pressure Steam Sterilization Of Medical Devices

Pressure steam dental instrument sterilization of medical equipment for all healthcare sectors most widely used kind of sterilization equipment , medical safety and the prevention, control the spread of infectious diseases important part . Its sterilization operations requirements and test monitoring and management is crucial. Therefore, the characteristics and existing detection techniques pressure steam sterilization of medical equipment , improve equipment through the use of technology and new detection methods to achieve pressure steam sterilization of medical equipment for the overall quality control.

Pulsating Vacuum Sterilizer Autoclave Vertical – Bluestone Ltd

Pressure steam sterilization of medical devices Overview

1 , Introduction and classification

Also known as high-pressure autoclaves sterilizer is essential health units Medical Equipment , it is the use of high-pressure steam sterilization equipment. Suitable for high temperature, high humidity sterilization of medical instruments and items. Pressure steam sterilizer according to the manner and extent of cold air emissions from different exhaust pressure pre-vacuum steam sterilizers and autoclaves divided under two categories .

2 , the basic principle

Sterilization refers to the use of physical or chemical methods to kill or remove all biological emblem on the media, so as to reach the level of sterility . Pressure steam sterilization as a method of moist heat sterilization , is a very efficient method of sterilization . Pressure steam sterilization of bacteria in the body to make protein denaturation or coagulation, kill all bacteria and spores adenoids , so as to achieve the purpose of sterilization.

Under pressure steam sterilizer exhaust the basic principle is to use the principle of gravity displacement steam heat from the top down in the sterilizer , the cold air is discharged from the lower vent , all replaced by saturated steam , the use of the latent heat of the steam release the article to achieve the effect of sterilization.Stay tuned on .

Pre-vacuum steam sterilizer during operation , the first evacuated using mechanical methods , the negative pressure room so sterilizer , steam and heat to penetrate quickly sterilized article inside . Final working pressure up 205.8KPA, or above the temperature reached 132 ℃ begin sterilization, sterilization time after arrival , vacuum drying the sterilization objects quickly . According to a one-time or different times vacuum , divided into two pre-vacuum and pulsation vacuum , the latter due to repeated vacuum, air exclusion more thoroughly , the effect is more reliable.

3 , the basic structure

Different types of pressure steam sterilizer its structure varies, generally can be divided into the main body, four main door seal most of the equipment , piping and control systems are usually prepared for the double-layer metal , in order to ensure a sufficiently high order of the device pressure capability and good thermal insulation capacity ; within the chamber to use more good corrosion resistance of stainless steel , beautiful and durable ; shell using pressure and heat preservation material , requires not only beautiful and durable , but also the heat radiation devices is reduced to a minimum, effective protection of the environment .

Door seal composed mainly of mechanical transmission , rubber seals and safety interlock device installed specially processed to ensure the security and stability of the normal opening of the high-pressure sterilizers , sealing and high temperature environments.

Electric Steam Sterilizer Vertical Type, Sliding Door Autoclave, Top Loading Pressure Equipment – Bluestone Ltd.

Pipeline system into steam, air , water and compressed air lines. Autoclave entire process flow of gas liquids pipeline system , complete the pre- vacuum , heat and pressure , pressure relief and a series of sterilization drying step . Condition control system with control , timing , counting, and other control functions step , and mathematical operations and data processing is completed , the monitoring of the sterilization process .

Key performance indicators of the AUTOCLAVESALE sterilizing tattoo equipment process

Completion of the sterilization process three main performance indicators are: temperature, pressure and time. These three parameters are mutually affected joint action . According to the three laws of gas , saturated steam temperature and pressure with a fixed correspondence. The higher the temperature the greater the pressure of saturated water vapor . However, if a certain amount of residual air in the sterilizer , not directly on the magnitude of the pressure determines the temperature of the clinical result is often due to residual air sterilization failure. When the higher the temperature, the time required for sterilization will be shortened . The ultimate effect of sterilization which is determined by the effective temperature and maintaining the article of time.

Laboratory Equipment Maintenance

Laboratory Equipment Maintenance

Proper use and careful maintenance of electric steam steriliser equipment failures are generally able to exclude the basic duty laboratory assistant is one of the indicators reflect the ability of the laboratory experiment , the experimenter is a measure of sense of responsibility , one based on job performance and operational levels . Experimenter must carefully grasp the structure of the instrument , working principle and maintenance, and can eliminate common problems . This will improve the efficiency and durability of the equipment to ensure the equipment is in top working condition , to improve the quality of teaching has an important significance.

Vertical High Pressure Steam Sterilizer Autoclave LX-C – Bluestone Ltd.

A guide students on the proper use of equipment, laboratory staff must first be done:

1 new share for instruments, to fully understand its performance, master its rules only after commissioning .

2 , various types of equipment must strictly abide by the rules .

3 , finished instruments after each use , should be reinstated, wipe clean, and fill usage records .

4 , love the instrument , fair use, not sick run , a timely troubleshooting.

5 , shall not be lost parts and accessories and instructions.

Second, the equipment maintenance scope and technical requirements:

1, all equipment and implementing the ” person responsible for the prevention, regular maintenance and timely repair ” principle. Maintenance of equipment , maintenance , commissioning, repair is the responsibility of a small experimental members .

2 , routine maintenance : refers to routine maintenance and management procedures by operating equipment carried . Major projects include external cleaning , lubricating , tightening and visual inspection instruments and so on.Feel free to view to get more details.

3, the level of maintenance: This project is funded by an external device into the device’s internal ( global cleaning , lubricating and tightening ) , which may include a general disintegration of ( eg demolition of housing ) for partial disintegration of instrument maintenance checks and adjustment of the entire instrument is powered commissioning or tidal flooding and other content.

4 , two maintenance : This project is mainly refers to the instrument’s internal maintenance , which includes the dissolution or disintegration of inspection , adjustment, replacement of wearing parts of the main components of the general disintegration of the instruments available to be carried out , while also including complete sets of equipment inventory re- combination of all ancillary components , the replacement of one of the vulnerable parts . Also included is the use of various types of long time ( over three years ) to check the accuracy of instruments , calibration and calibration work. The instrument often in clean, lubricate , security and availability of technical condition.

Steam Sterilizer Autoclave Machine, Sliding Door, Digital Display and Automatic Autoclave – Bluestone Ltd.

5 , not to mention the impact of work in front of their own must be regularly administered instrument maintenance. In addition to routine maintenance, should be performed once a month on the main level of maintenance of the instrument. Cleanliness and temperature and humidity requirements more stringent instruments ( including special medicines, animal and plant specimens , etc. ) , in addition to routine maintenance , you should always check the status of these devices and storage environments . Dust, thermostat , dehumidification , anti-corrosion , pest control , shock , etc. Before the end of each school year , combined with inventory work on the instrument , to focus on the various types of equipment, materials or maintenance of a level .

Three instrument repair scope and technical requirements:

1 . Instrument repair is the repair due to normal or infrequently factors ( such as the use , poor maintenance human factors , etc.) caused by damage to the equipment, so as to restore ( recovered ) to the original state of the art .

2 repair work on the principle borne by the experimenter , but due to the different technical capabilities each service , so who require disassembly, replacement parts , or overhaul of AUTOCLAVESALE medical waste autoclave equipment , must approve the submitted materials division .

3 who found the instrument does not belong to a fault occurs within the warranty coverage , you should immediately stop using it. Materials submitted to the laboratory responsible person or department audited to determine the degree of fault and repair personnel , by the repair person fill out the ” instrument repairman card ” after repair work can be carried out . After the repair work , the person in charge or reporting laboratory supplies department , signed after acceptance , the end of the repair work on the use of personnel , equipment put into use.

Heat Sterilization And Disinfection Development

Heat Sterilization And Disinfection Development

Disinfection and dental instrument sterilization methods available in all of the heat is an application of the earliest , most reliable results , the most widely used methods. Heat can inactivate all microorganisms, including bacteria, fungi, viruses, and strong resistance to most bacterial spores before . Therefore , not only the thermal disinfection and sterilization is widely used in medicine and in industry are sterilized by attention.

Automatic Table Top Autoclave, Digital Display Sterilizing Time and Temperature – Bluestone Ltd.

Human thermal disinfection, sterilization and antisepsis has a long history , primitive and ancient people already knew how to use fire to heat food , have prevented its corruption. After entering the Middle Ages , people used fire to burn the patient’s clothes and body, to prevent epidemic diseases.

1718 , Joblot boil for 15 minutes with a reagent sterilization methods , and then enclosed in a container .

Later , Appert (1810) developed a method using heat sterilization of food and stored in an airtight container , similar to canned food now . 1832 , Henry found that the higher the heating temperature , the greater the bactericidal power .

In 1876 , Tyndall invented the intermittent AUTOCLAVESALE sterilizing tattoo equipment sterilization . 1880 , Chamberland developed autoclaving .

1881 , koch compared 117 ℃ heat and dry heat sterilization , noting that the heat resistance of the bacteria in the presence of water vapor conditions exist vary widely. The same year in the case of water vapor saturated and unsaturated Effect of sterilization , Kinyoun (1888) suggested that when using autoclave sterilization , if the exhaust air before trying to pass steam sterilizer within it is close to vacuum , then sterilization is easy to succeed , this is called “pre- vacuum .”

In 1897 , Kinyoun developed a sandwich autoclaves, sandwich filled with steam to maintain high humidity , combined with pre-vacuum , so sterile easy to dry. Underwood (1915) envisaged in the exhaust pipe mounted on the autoclave , a steam sterilizer enter the encounter article to be sterilized , heat is absorbed , the proportion of steam increases with the temperature drop through the upper saturated steam sterilizer when the temperature is low due to the relationship between the proportion of the steam to move along the lower portion , as mounted on the bottom of the exhaust pipe disinfection , the heavier water vapor is drawn or conducive to the flow of steam . Kinyoun this idea to practical . After the autoclave was further improved to 1933 Underwood complete the basic structure of a high voltage used today .

Table Top Autoclave for Sale – Bluestone Ltd.

Zinsser dry heat sterilization have been studied and found that the insulating effect of the packaging material can lower the local temperature of the object , so that the sterilization failure.Stay tuned on .

1939 VallerRadot established a dry heat sterilization , dry heat sterilization raised temperature should not be less than 150 ℃, reaction time should be 30 minutes or more. These studies on the application of heat sterilization and disinfection has played a significant role in promoting .

How To Calculate The Sterilization Time Reasonably

How To Calculate The Sterilization Time Reasonably

Calculation of time -pressure portable steam autoclave sterilization , sterilization cabinet interior should be reaches the required temperature , counting to sterilization is completed. Total time including : thermal penetration time, that reaches to the autoclave sterilization temperature from the central part of sterile sterilization temperature has reached the desired time.

Portable Autoclave Sterilizer Machine YX-280B – Bluestone Ltd

The length of time depends on the type of nature sterile , packaging size , placement and extent of air evacuation of the autoclave and sterilizer . Sterilization holding time , i.e. the time required to kill microorganism , usually with Bacillus stearothermophilus spores kill time required to represent. 30 minutes , 12 minutes at the time when 121 ℃ 115 ℃, 132 ℃ when required 2 minutes . Safety time , usually half the time to maintain , depending on the length of its articles may be sterilized . Easy thermal sterilization of metal equipment , no safety time .Check more details on .

Generally required under the exhaust autoclaves time : 115 ℃ 30mins, 121 ℃ 15mins, 126 ℃ 10 minutes. Commonly used in the pharmaceutical industry, sterile 115 ℃. In the microbiological laboratories , some sugar medium are sterilized with 115 ℃ 30mins because glucose is decomposed at a higher temperature .

Over Heating Protection Steam Sterilizer Autoclave Portable – Bluestone Ltd.

121 ℃ ~ commonly used in health and epidemic prevention work in sterile 126 ℃. The approximate number of the above knowledge AUTOCLAVESALE electric steam sterilizer sterilizing time , a specific sub- sterile how much time is required according to the type of goods , packaging size , placement conditions and to determine the performance of the sterilizer . The following table provides the data available for the practical work of reference .

After Sterilization Qualified Products

After Sterilization Qualified Products

After the high-pressure steam vertical autoclave sterilizer , sterilization quality monitoring for disinfection of the water content of the package failed to make clear the specific requirements set forth in the general hospital of Autoclaves Sterilizers .

Steam Sterilizer Autoclave Machine, Sliding Door, Digital Display and Automatic Autoclave – Bluestone Ltd.

Once a month for biological monitoring , must be qualified daily air furnace for BD test must be qualified, the surgical kits and disinfection instructions tape instruction card display to achieve disinfection requirements is considered to achieve the purpose of sterilization , disinfection and sterilization in which the main factors affecting the quality of the sterilization temperature, pressure and time . Feel free to visit to get more info .So when the end of the sterilization process, as long as all the requirements to monitor compliance with the instructions , may be considered to have sterilization qualified.

Drying Oven, Heat by Forced Churned-up Hot Air Circle, Digtial and Micro-computer Type – Bluestone Ltd.

But why not allow a ” wet bag ” ? Mainly because of preservation , we know, norms , the general requirements for disinfection after sterilization in a dry sterile package to save the area , clean the shelves , in peacetime can be retained for 14 days, yellow mold days only allowed to retain 7 days , this is mainly caused by the growth of microorganisms sweat easily , if , after AUTOCLAVESALE dental autoclaves sterilization , disinfection package itself is not sufficiently dried , it will directly affect the storage time, or even parts of the package equipment corrosion occurs , the impact of the use , once a ” wet pack ” ( metal box found drops of water disinfection , feel damp cloth or wet marks ) shall notify the maintenance department check processing immediately or appropriate to extend the drying process time .

Common Method Of Sterilization

Common Method Of Sterilization

Heat sterilization method using high temperature so that all protein denaturation, microbial activity within the cell disappears , resulting in cell death. Usually dry heat, moist heat and intermittent heating portable autoclave sterilization .

Benchtop Steam Sterilizer Automatic Sterilization Controlled by Micro-computer – Bluestone Ltd

Dry heat sterilization of microorganisms directly by flame will burn ( eg burning ring vaccination , slides and tube mouth , etc. ) . Items can not be sterilized with a flame is hot air sterilization , the items placed in an oven heated to 160 ~ 170 ℃, 90 minutes , this law applies to glass, metal and wooden utensils .

Heat sterilized in boiling water , steam and steam pressure sterilization. Pasteurization is a heat sterilization , this method there are two ways , ① prolonged cold treatment: treatment at 61.7 ~ 62.8 ℃ 30mins; ② high temperature short time treatment: treatment at 71.6 ℃ or slightly higher temperature for 15 minutes . In the dharmas , the pressurized steam sterilization to the best available pressure steam sterilization , high pressure steam can also be pot ( generally using 1 kg / cm 2 ) sterilization, the steam temperature up to 121 ℃, the spores can heat in 30 minutes to kill all . However, for some high pressure easily damaged materials, such as certain sugars or organic nitrogen-containing compound , preferably at 0.6 kg / cm 2 pressure (110 ℃) 15 ~ 30 minutes sterilized .Feel free to check for more details.
Tyndallization 3 consecutive days , once daily steam sterilization method . This law applies to not more than 100 ℃ temperature resistant material and some of the carbohydrates or protein substances . Is generally at normal atmospheric pressure steam sterilization for 1 hour. Sterilization temperature does not exceed 100 ℃, without causing damage to sugar and other substances , which may be intermittent during spore germination of cultured kill to achieve complete sterilization purposes.

Under certain conditions, radiation sterilization using radiation sterilization method . More commonly used ultraviolet , there are other ionizing radiation ( rays accelerate neutrons , etc. ) . Laser wavelength between 25,000 and 80,000 nanometers have a strong bactericidal ability to 26500 nanometers wavelength is most effective. Radiation sterilization is limited to certain certain materials, due to the complexity of the necessary equipment , difficult to widespread use.

Horizontal Cylindrical Pressure Steam Sterilizer Autoclave Bluestone Ltd

Osmotic solution sterilized using high osmotic pressure method of AUTOCLAVESALE high pressure autoclave sterilization . In high concentrations of salt or sugar solution, the cells occurs due to dehydration plasmolysis , can not be normal metabolism , resulting in the death of microorganisms.
Most chemical sterilization chemicals from the inhibitory effect at low concentrations , bactericidal effect at high concentrations. Common 5% carbolic acid and 70 % ethanol , and ethylene glycol . Chemical sterilizing agent must be volatile in order to remove the residual material after sterilization drugs .

What Is Pressurized Steam Sterilization

What Is Pressurized Steam Sterilization

Pressurized steam autoclave sterilizers, sterilization items will be placed in a sealed pressure steam sterilization pot and steam into the pot and the pressure increases, the boiling point of water also will increase Yu . Under normal circumstances , the relationship between temperature and vapor pressure line is as follows:
Different steam pressures attainable temperature
Pressure ( lb / cm2) 5 10 15 20 25 30
Temperature (℃) 108.8 115.6 121.3 127.2 130.4 134.6
In 1.05kg/cm2 (0.1mpa) that the vapor pressure of 15 pounds , the pot temperature reached 121.3 ℃, 30 minutes , including spores were killed , including all bacteria and viruses.

Steam Sterilizer Autoclave Machine, Sliding Door, Digital Display and Automatic Autoclave – Bluestone Ltd.

Heat sterilization of a factor Effect
( A ) Temperature : temperature , sterilization time was significantly shortened.
( 2 ) Bacteria: different types and even different strains of bacteria resistant to heat may be different ; higher concentration of bacteria , requiring sterilization longer .
( 3 ) medium ; heat can affect the nature of the sterilization medium , protein , fat and other bacteria have a protective effect .
(4) pH: bacteria in the neutral medium maximum resistance to heat , easily killed when acidic or slightly alkaline .Stay tuned on to get more updates.

2 should be used with high-pressure steam sterilization precautions
( 1 ) try to exclude the air sterilizers : You must have the device when using autoclaves air drained . If there is the presence of air in the sterilizer , the sterilization temperature will affect reasons: steam mixed with air, it will affect the thermal conduction time of the pressure in the right as shown , and heat is not consistent , and thus resulting in incomplete sterilization . There kiln retained partial retention effect , making it difficult to penetrate the heat , even the formation of temperature stratification , so sterilization should pay close attention to the temperature of the pot . Check that the air drained methods are: install a thermometer in the exhaust port , such as the exhaust gas temperature reaches 100 degrees Celsius when the air has drained pot instructions ; hose in the exhaust port set to the other end opening into the cold water basin , and if small bubbles emerging, there is still an air discharge instructions .

Double Door Autoclave Horizontal Steam Sterilizer HT-HZA – Bluestone Ltd.

( 2 ) controlling the heating Moderate : As a rule, the sterilization time is the time to reach the required sterilization temperature within the piano counting , such as by flash heating , the desired temperature for five minutes , the contents inside the sterilizer 20 minutes after order to achieve the required temperature ; as with slow heating , when the 20 minutes to reach the desired temperature sterilization , the sterilization goods in the next five minutes to reach the required temperature . Therefore, the heating temperature sterilization should not be excessive .
( 3 ) do all the work before the prospective sterilization are : ① items prior to sterilization should minimize contamination and maintain the cleanliness of items in order to better ensure its sterilization effect ; ② pack ritual items used properly there are both timber farming both good steam penetration , but also to block the outside world only biological invasion , and more generally in brown paper ; bandage should not be too tight , to facilitate the flow of steam ; installed capacity ③ sterilized items should not be too full , or about the volume of both 3/ 4 , the container hair leaving space for vapor flow .
( 4 ) preferably placed at different locations in the thermometer or temperature indicator AUTOCLAVESALE sterilization equipment , the sterilization temperature in order to understand the situation . Temperature indicator used to contain benzoic acid and bromine phenol musk orchid (Bromothymol blue) called sterilization certificate. Because formic acid melting point of 121 ℃, such as sterilization temperature reaches 121 ℃, acid melts encounter that bromothymol blue to red . Biological indicators are used to monitor a strong tolerance to heat death of Bacillus stearothermophilus (Bacillus sterothermophilus ATTCC 7953, SSIK 31) death spores to determine the success of sterilization .

Various Sterilization

Various Sterilization

First, the heating method :
Dry heat method : flame burning hot air sterilization and electric steam steriliser.
A flame burning applies to ring vaccination , inoculation needle and metal utensils such as tweezers , tube and bottle mouth , coated with a glass rod .
2 , hot air sterilization using high-temperature dry air (160-170 ℃) heat sterilized 1-2h, suitable for glassware and dish and so on. Principle heating denatures proteins , and water content , and when the larger environment and cell water content , the faster solidification .

Horizontal Autoclave, Front Loading, Automatic Sterilization – Bluestone Ltd

3 , note:
1 ) medium , rubber products, plastic products can not use this method ;
2 ) temperature controlled at <180 ℃;
3 ) Items not too crowded ;
4 ) when the temperature was lowered to 70 ℃ box door.
Second, heat method :
Principle: Because the bacterial heat -absorbent, easy coagulation proteins , due to increased water content of proteins required solidification temperature decreases ; humid steam latent heat exists. So the effect of dry heat better than the same temperature .Stay tuned on .
Third, the high-pressure steam sterilization method :
1 Equipment: Autoclave
2 , the length of time depending on the type and number of different variations of sterilized items .
3 , suitable for sterilization medium , overalls , rubber goods, etc. , can also be used for sterilization of glassware .
4 Note :
1 ) cold completely rule ; 2 ) water ; before opening 3 ) pressure drop to “0” .
Fourth, the atmospheric steam sterilization :
Should not be used for the medium pressure steam sterilized medium such as gelatin , milk medium , this method can be sugar culture medium . Thorough sterilization is intermittent sterilization methods.
Boiling sterilization method :
Applicable syringes and dissected vessels, time 10-15min,
135-150 ° C and 2-8s for milk and other liquid food .
Advantages : Keep food value and nutrients.
Fifth, the filter sterilization :
Principle: When the medium pressure barrier microorganisms.
Scope: Many materials such as serum , antibiotics and sugar solution using this method .
Equipment : Chua filters, membrane filters.
Advantages and disadvantages: not destroy medium components for only a small filtrate. Require a lot of sterile air and clean bench .

Drying Oven, Heat by Forced Churned-up Hot Air Circle, Digtial and Micro-computer Type – Bluestone Ltd.

Note: 1 , the pressure appropriate ;
2 , under sterile conditions ;
3, to prevent infiltration phenomenon .
Sixth, radiation sterilization :
Principle: UV wavelength at 200-300nm, has a bactericidal effect , with strong bactericidal 265-266 . Nucleic acid susceptible cells paragraph absorption wavelength ; can produce ozone and hydrogen peroxide . Bactericidal effect and is proportional to the product of intensity and time .
Cons: little penetration . From irradiated <1.2m appropriate. Applications: sterile room , hospital.
Note: eye and skin irritation.
AUTOCLAVESALE steam autoclave sterilizer: r -rays , penetrating power , suitable for sterilization stacked items.
Seven chemical sterilization :
Principle : The application of chemical agents destroy bacteria metabolism .
Fungicides such as heavy metal ions.
Antibacterial agents such as sulfa and most antibiotics.
Note : the level of concentration of drugs , length of time , in which microbial species and microbial environment.
Common chemical fungicides are: ethanol , acetic acid, carbolic acid
Formalin , mercuric chloride , potassium permanganate, Bromogeramine

Stainless Steel Portable Pressure Steam Sterilizer Instructions

Stainless Steel Portable Pressure Steam Sterilizer Instructions

Stainless Steel Portable Pressure Steam Sterilizer Instructions

1 water plus water in the autoclave steam sterilizer to the above heating pipes (about 3 liters), continuous use must be added above the water.

2 Seal: would require sterilization of items evenly scattered and orderly placed in sterilized bucket and then sterilized bucket into the sterilizer, and the cover lid, put the hose into the steam sterilization barrel Galteli inside. After the alignment of the upper and lower groove, symmetrical wingnut tightened to seal the requirements (use if the situation continues to leak tighten the nut can be removed).

3 heating: After ohmic heating, take the child on the first release valve deflated vertical position, so that the cold air sterilizer overflow, when steam emitted when the bleed valve then take the child reset. When the pressure reaches the desired range sterilization, sterilization start time is calculated according to a different article.Get the latest news on .

4 Drying: After instruments, dressings, utensils and other disinfection required when dry, can be disinfected after the end of the steam sterilizer release valve to drain. When the gauge is reset to zero for 1-2 minutes. Then open the lid and continue heating 10min to achieve the purpose of drying.


1 Note that the water level before each sterilization to avoid damage to heating pipes empty beaker.

2 different items should be classified sterilization.

3. Always check the pressure gauge when the gauge pointer is not reset, the reading should be allowed to cut off the heat, promptly repair or replace the pressure gauge.

4 When the AUTOCLAVESALE dry heat sterilizer work, the staff do not leave the scene.

Various Sterilization Introduction

Various Sterilization Introduction

Sterilization by means of a suitable physical or chemical means to kill microorganisms living in the article or method to remove. This law applies to sterile preparation , raw materials, accessories and medical equipment and other items . Sterile refers to goods does not contain any living micro-organisms . However, for any number of steam bottle sterilizer products, both can not guarantee absolute sterility test can not be used to confirm . Physical or chemical means sterilization tests showed : kill microorganisms on the number of rules to follow , therefore , sterile sterilized items after items sterilization standards generally microbial survival probability – sterility assurance level SAL (Sterility Assurance Level) said . Probability of surviving microorganisms terminally sterilized product shall not exceed 10-6. Sterilized products meet the sterility assurance level can be determined by verification. Sterilization and sterility assurance products can not rely on sterility testing of the final product , but on the process used in the production of qualified sterilization process , strict management and good GMP comprehensive quality assurance system. Sterilization process should be determined by considering the nature of the items to be sterilized , effective and economic method of sterilization , the sterilization integrity and stability of the article and other factors .
Validate the sterilization process is a necessary condition of sterility assurance . Sterilization process validated only after the delivery of official use. Verify that include:
⑴ written verification program and the development of assessment criteria.
⑵ confirm sterilization equipment technical information is complete , correct installation , and can be in normal operation ( Installation Qualification ) .
⑶ confirm critical control equipment and instrumentation to the normal operation ( OQ ) within the parameters specified .
⑷ using sterilized items or items repeated simulation tests to confirm compliance with the sterilizing effect ( Performance Qualification ) .
⑸ Summary and improve a variety of documents and records , written verification reports. Daily production in response to the operation of sterilization procedures to monitor , identify key parameters ( such as temperature , pressure, time , humidity, gas concentration and irradiation sterilization absorbed dose absorption , etc. ) are within the range defined in the verification .

Vertical Autoclave Sterilization Machine LX-B – Bluestone Ltd

Sterilization procedures should be periodically re- verified. When changes (including sterilization load and number of items changes ) occur when sterilization procedures , should be re- verified. Characteristics of the product prior to sterilization and sterility assurance products is the extent of contamination and pollution associated bacteria . Therefore, strict monitoring of microbial contamination levels before sterilization and sterilization product contamination tolerance of bacteria , and to take all measures in all aspects of production to reduce pollution and ensure control of microbial contamination within the specified limits . After sterilization, the sterilized items should prevent recontamination . Under no circumstances , should be required to ensure that the product container and sealing system in the period in line with sterile requirements.
Sterilization methods have used methods of sterilization heat sterilization , dry heat sterilization , gas sterilization , radiation sterilization and sterile filtration method. The method may be employed in combination with one or more items to be sterilized in the sterilization according to the characteristics . As long as the product allows , should be chosen as the final sterilization method ( ie, product packaging to packaging containers after sterilization ) sterilization. If the product is not suitable for terminal sterilization method , the choice of filter sterilization method or sterile production process sterility assurance requirements, whenever possible , to deal with non- terminally sterilized products as complementary sterilization ( such as circulating steam sterilization ) .
First, heat sterilization
Items will be placed in this Act shall mean the use of high-pressure saturated steam sterilization cabinet , hot water spray and other means to make the microbial cell protein, nucleic acid denaturation and kill microorganisms . The Act sterilization capability for heat sterilization is the most effective and most widely used method of sterilization . Medicines, container , medium , sterile clothing, and other items stopper when the temperature and humidity do not change or damage are available sterilization law . Live steam can not completely kill bacterial spores , and can be used as an auxiliary heat- sterilized instruments sterile products .
Moist heat sterilization conditions usually 121 ℃ × 20min or 116 ℃ × 40min procedure can also be used with other temperature and time parameters . In short , we must ensure that SAL items after sterilization ≤ 10-6. The thermal stability of the article , can be over- kill method, the SAL should be ≤ 10-12. Standard AUTOCLAVESALE sterilizing tattoo equipment of heat-sensitive products F0 time may be less than 8min, but it should be in the whole production process, the product of strict monitoring of microbial contamination , and to take all measures to prevent pollution and reduce microbial resistant bacteria pollution levels , ensure that sterilized product sterility assurance requirements.
When using moist heat sterilization , should be sterilized items are packed and loaded the appropriate way to ensure the effectiveness and uniformity of sterilization .
When moist heat sterilization process validation , testing should be conducted heat distribution , heat penetration testing and validation testing of biological indicators . To determine the distribution of heat sterilizer load and load when the different chambers and the possible existence of cold spots ; under no-load conditions , the temperature difference is recognized when the chamber 121 ℃ points should be ≤ ± 1 ℃; Use temperature probe inserted into the actual items or items within the simulation confirmed sterilizer at different loading , the coldest point of the article standard sterilization time (F0) to reach the set standards ; further confirmed when the cold spots at different loading biological indicator sterilized items at a sterility assurance level. Law is commonly used biological indicators Bacillus stearothermophilus spores (Spores of Bacillus stearothermophilus).

Digital Autoclave Vertical, Pressure Steam Sterilizer Automatic Sterilization Equipment

Second, the dry heat sterilization
Law refers to items in the dry heat sterilizer , sterilization tunnel and other equipment , the use of dry and hot air to kill the microbes or eliminate pyrogen approach. But not suitable for high-temperature sterilization with moist heat sterilization sterilization items , such as glassware, metal containers, fiber products , solid reagents , liquid paraffin etc Act can be sterilized .
Dry heat sterilization conditions is generally 160 ~ 170 ℃ × 120min above , 170 ~ 180 ℃ × 60min or more, or 250 ℃ × 45min or more , may also have other temperature and time parameters. In short , should ensure that their products after sterilization SAL ≤ 10-6. After the dry heat over the killing of products SAL should ≤ 10-12, this time items generally determined prior to sterilization without microbial contamination . 250 ℃ 45min dry heat sterilization can also be removed by aseptic packaging containers and related equipment in the production of filling pyrogenic substances.
When using dry heat sterilization , should be sterilized items are packed and loaded the appropriate way to ensure the effectiveness and uniformity of sterilization .
Dry heat sterilization and moist heat sterilization validation same test should be carried out heat distribution , heat penetration test, validate biological indicator inactivation of bacterial endotoxin test or validation tests. To confirm the sterilizer temperature distribution in compliance with the standards set , to determine the coldest point , confirm the coldest point standard sterilization time (FH) can reach the set standards and achieve SAL requirements. Commonly used as a biological indicator Bacillus subtilis spores (Spores of Bacillus subtilis). Inactivation of bacterial endotoxin test in addition to verification test is to prove the effectiveness of pyrogenic process . Will generally not be less than 1,000 units of the bacterial toxin to be added to the items of pyrogen , the pyrogen- proof inner process can go down at least three pairs of endotoxin unit. Bacterial endotoxin test to verify inactivation of bacterial endotoxin used generally within Escherichia coli endotoxin (Escherichia coli endoxin). When validated , the general maximum loading mode .
Third, the radiation sterilization
Law refers to the electron beam sterilization product in the γ -ray radiation sources suitable or desirable for the occurrence of electron accelerators ionizing radiation to kill the microorganisms . Law is the most commonly used 60Co-γ ray radiation sterilization. Medical equipment, containers , production aids, from radiation damage of pharmaceutical raw materials and finished products etc. Sterilization Act is available .
Radiation sterilization sterilization method using sterile product which SAL should ≤ 10-6. γ -ray radiation sterilization is mainly controlled by the parameters of the radiation dose ( absorbed dose refers sterilized items ) . The dose should be considered sterile goods develop adaptability and the maximum number of possible microbial contamination and the strongest anti- radiation, the dose should be used in advance to verify its effectiveness and safety . The absorbed dose of radiation sterilization used as 25kGy. The final product , bulk drugs, certain medical equipment sterilization should be used whenever possible low radiation dose . Before sterilization, items to be sterilized response quantity of microbial contamination and radiation intensity was measured to evaluate the sterilization process of the sterilized items given sterility assurance level .Stay tuned on .
When sterilization should be appropriate chemical or physical methods for sterilizing articles absorbed radiation dose monitor the extent to fully confirm the sterilization dose is absorbed in the article required . Such as the use of radiation and sterilization items are together radioactive dosimeters , dosimeter to put the provisions of the site. Dosimeter in the early installation using standard calibration source and regularly re- calibration.
When 60Co-γ ray radiation sterilization validation, verification testing in addition to biological indicator , it should also confirm that the radiation dose distribution of load and loading chamber sterilization , sterilization items absorbed dose and the maximum and minimum absorption dose distribution uniformity , loading patterns sterilization chamber and other items sterilized items . Commonly used as a biological indicator Bacillus pumilus spores (Spores of Bacillus pumilus).