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Thermo Scientific Steri-Run Sterilization Cycle Proves Total Sterilization

Key Words

CO2 Incubators, Sterilization, Decontamination, Cell Culture

Introduction tested by the Investigation Unit of the Public ™ Health England Institute at Porton Down, UK (PHE). The A new Thermo Scientific CO2 design incorporates the Thermo Scientific™ Steri-Run™ materials, methods and results of that testing3 are provided sterilization cycle. The Steri-Run cycle includes a here. Normally the Steri-Run cycle holds at 180 °C for 90 2 hour heating phase, followed by a 1.5 hour sterilization minutes, but the unit tested for microbiological elimination phase at 180 °C, and a final cool-down phase of was modified to hold at 180 °C for only 45 minutes to approximately 8 hours. At the completion of the cycle, the meet the overkill requirements by administering half the incubator is returned to the set incubation temperature. lethality of the full cycle. Technically, something is sterile when there is an absence of As part of internal specification measurements for life. Since it is not possible to prove that no IQ/OQ requirements, temperatures throughout the exist in or on a given article, we can definesterile by using Steri-Run cycle were measured twice each in four units proof of probability. Sterilization is a carefully defined at 47 locations. Temperature mapping proves that all term in pharmacopeias from both the European Union1 areas reach and hold at the specified temperature. Those and the United States2. Each defines sterilization as proof methods and results are also presented. that there is less than a one in one million (106) chance that Materials and Methods any survived the process. Each requires Microbial species proof of a 6-log (1 x 10-6) reduction of microorganisms. Also, during dry heat sterilization, the air must be kept Based on recommendations of the U.S. Pharmacopeia2 continuously circulating using a fan or blower. In order to and the EU Pharmacopoeia1 (EUP), the following be assured that all areas reach the specified temperature, microorganisms were tested by PHE: detailed temperature mapping should be provided. This is • Bacillus atrophaeus (ATCC 51189, NCTC10073), important because areas that do not heat to high enough a.k.a. Bacillus subtilis. This is the indicator for dry heat temperature for a long enough time could allow some sterilization in the U.S. Pharmacopeia and the EU microorganisms to survive. Pharmacopoeia, among others, due to the resistance of In an empty chamber such as an incubator, products are the to heat and desiccation. A PHE stock not sterilized which can later be tested for the presence batch of suspension was diluted in sterile 9 of microorganisms. Therefore, Thermo Scientific CO2 distilled water to a concentration of 5.00 x 10 colony incubators are tested following the requirements in the forming units per mL (CFU/mL). U.S. Pharmacopeia (USP) for statistical proof using • Escherichia coli (ATCC 25922, NCTC 12241). E. coli the overkill method. This approach requires that you are commonly used in cell and molecular biology prove elimination of at least 1 x 106 heat resistant and can be a contamination concern. A bacterial endospores, and then double the treatment for new vial was obtained from the National Collection of an additional 6-log reduction, providing a total 12-log Sterility Assurance Level (SAL). In order to comply with these requirements and show

that Thermo Scientific CO2 incubators with the Steri-Run

sterilization cycle achieve total sterilization, a CO2 incubator with the Steri-Run cycle incorporated was 2 Type Cultures (NCTC) and stock plates made. A full • Mycoplasma pneumoniae (ATCC 15531, NCTC loop of E. coli was added to 10 mL of Nutrient Broth 10119). This is one of approximately 100 mycoplasma in a universal glass and incubated 18-24 hours at species (estimates vary). Mycoplasma are technically 37 °C (+/- 2 °C). The suspension was then assayed to , but do not have a cell wall and are therefore determine the concentration of the bacteria. A 1:10 immune to common antibiotics. As human pathogens dilution was made and 0.1 mL deposited onto and normal flora, mycoplasma are common cell culture duplicate Tryptone Soya (TSA) plates and contaminants. PHE obtained a liquid suspension of incubated 18-24 hours at 37 °C (+/- 2 °C). The M. pneumoniae from NCTC. The storage medium colonies were counted to determine CFU/mL. was removed by centrifugation at 4,400 rotations per minute (rpm) for 10 minutes and the supernatant • Aspergillus brasiliensis (ATCC 16404). This is a black removed. The pellet containing the bacteria was fungal mold, usually living in soil but a common type resuspended in 1 mL of Mycoplasma Horse Serum of contaminant in cell culture laboratories. Ten Malt Broth (MHSB) and stored at 4 °C (+/- 2°C) until use. Extract Agar (MEA) plates carrying A. brasiliensis conidiospores were grown to confluency over 5 days at Preparation of test coupons 30 °C (+/- 2 °C). Five mL of a suspension of 0.1% For each test, a 10 µL preparation of each Tween in sterile distilled water was pipetted onto microorganism was deposited by onto a 1 cm each plate to remove the spores. The spore-containing diameter round, sterile, coupon. The suspension was recovered from the plate and coupons were dried at 37 °C (+/- 2 °C) for 1 hour. transferred to a sterile universal container. 0.1 mL For each test microorganism, 7 coupons were prepared of this suspension was deposited onto duplicate for each of the 3 sterilization tests. TSA plates. These were incubated 3-5 days at 30 °C (+/- 2 °C) and counted to determine the concentration Procedure for each sterilization test of 1.00 x 106 CFU/mL. Prepared coupons for each of the 5 test microorganisms

• Geobacillus stearothermophilus (ATCC 12980, NCTC were placed into the Thermo Scientific CO2 incubator 10339). Due to their superior resistance to heat and with the Steri-Run cycle. One coupon for each desiccation, endospores of G. stearothermophilus are microorganism was placed in each of the following the indicator for sterilization in the U.S. locations (Figure 1): Pharmacopeia and EU Pharmacopoeia, among others. • Middle shelf (of 3) Coupons containing G. stearothermophilus endospores at a concentration of 2.80 x 106 CFU/mL were • Bottom shelf purchased from APEX Laboratories, Inc. The coupons • Back wall next to the plenum were stored at 4 °C before use, and were removed from the packaging immediately before they were placed • Glass door into the incubator. For the glass door and back wall, the coupons were hung from hooks. Figure 1. Interior of the Thermo Scientific CO2 incubator with Steri-Run cycle, indicating the locations of coupons containing The Steri-Run cycle was initiated near the end of the test microorganisms. work day and according to the manufacturer’s instructions. The incubator heated from 37 °C to 180 °C over approximately 2 hours, then held at 180 °C for 45 minutes. Normally this 180 °C phase in the Steri-Run cycle lasts for 90 minutes, but this unit was modified in order to test effectiveness at half the designed lethality. Back Wallwall Following the 180 °C phase, the incubator followed its automatic cool-down to the set temperature of 37 °C, MiddleMiddle shelf Shelf over approximately 7.5 hours. Controls

For each of the tested microorganisms, 3 positive and negative controls were conducted for each test run. The positive controls were prepared in the same manner as the test coupons, but not placed into the incubator during the sterilization cycle. For the negative controls, Bottom Shelf GlassGlass Door door Back wall uninoculated sterile coupons were assayed. Microbial analysis

The coupons were collected following the Steri-Run cycle. For the first test run, the coupons inoculated with B. atrophaeus, E. coli, A. brasiliensis, and G. stearothermophilus were transferred to individual universal containers that contained 10 mL of Phosphate 10 mL of nutrient broth. All were incubated at the 3 Buffered Saline (PBS). The coupons that were inoculated appropriate temperature (see above) for 7 days. During with M. pneumoniae were transferred to individual this time, any cloudiness in the growth medium signified universal containers that contained 10 mL MHSB. microbial growth and a positive result, indicating survival Each was mixed using a for 10 minutes during the Steri-Run cycle (Figure 2). to dislodge remaining microorganisms. 0.1 mL of the Following all 3 Steri-Run cycle test runs, all the coupons suspension was spread onto duplicate agar plates to inoculated with M. pneumoniae and transferred to give a quantitative Total Viable Count (TVC). All were universal containers containing 10 mL of MHSB were assayed using TSA plates except M. pneumoniae, which incubated at 37 °C (+/- 2 °C) for 14 days. During this was assayed using Eaton’s Agar plates. time, any color change from red to orange-yellow • B. atrophaeus: The PBS suspension was further serially signified a positive result, indicating survival during diluted in PBS. 0.1 mL of 10-2, 10-3 and 10-4 dilutions the Steri-Run cycle (Figure 3). was spread onto duplicate TSA plates and incubated at 37 °C (+/- 2 °C) overnight and any colonies counted. Figure 3: Example of no growth/negative control (red) or growth/ positive control (orange-yellow) of M. pneumoniae in MHSB. • E. coli: The PBS suspension was further serially diluted in PBS + 0.1 mL. 0.1 mL of 10-1 and 10-2 dilutions was spread onto duplicate TSA plates and incubated at 37 °C (+/- 2 °C) for 48 hours and any colonies counted. • A. brasiliensis: The PBS suspension was further serially diluted in PBS. 0.1 mL of 10-1 and 10-2 dilutions was spread onto duplicate TSA plates and incubated at 30 °C (+/- 2 °C) for 3 days and any colonies counted. • G. stearothermophilus: The PBS suspension was further serially diluted in PBS. 0.1 mL of 10-2, 10-3, and 10-4 dilutions was spread onto duplicate TSA plates and incubated at 60 °C (+/- 2 °C) overnight and any colonies counted. • M. pneumoniae: The MHSB suspension was further serially diluted in PBS. 0.1 mL of 10-1 and 10-2 dilutions was spread onto duplicate Eaton’s Agar plates and incubated anaerobically at 37 °C (+/- 2 °C) for a minimum of 14 days and any colonies counted. The results of the first sterilization run showed a total kill, so PHE elected to do a qualitative test for the second Negative Positive and third runs. Here, the coupons for B. atrophaeus, Negative Positive E. coli, A. brasiliensis, and G. stearothermophilus were Mathematical determination of the effectiveness transferred to individual universal containers containing of the Steri-Run cycle Figure 2. Example of no growth/negative control or growth/ In keeping with the USP and the EUP, the effectiveness of the positive control of microorganisms in Nutrient Broth. Steri-Run cycle is given in terms of log reduction of the test microorganisms. Log reduction is determined as follows:

Log = Average total CFU of positive control Log Reduction ( Average total CFU per sample ) 10

Measurement of temperature during the Steri-Run cycle

To confirm that all areas of the incubator reached 180 °C for a minimum of 90 minutes during the Steri-Run cycle, 4 different units were each tested twice, once with a standard glass door and once with a segmented glass door. Forty-seven electronically calibrated nickel-chromium/ nickel thermocouples with an accuracy of +/- 1 °C were distributed in the chamber including the left, right and rear walls, ceiling, water reservoir floor, water reservoir cover, glass door, and 3 shelves. The probes were Negative Positive touching the surface in all areas except on the shelves, Negative Positive 4 SPANISH

Tables 1-5: Results of microbiological tests. Each test was performed on a different day. thermoscientific.com Positive controls were treated the same as samples exposed to the Steri-Run cycle. © 2013 Thermo Fisher Scientific Inc. Reservados todos los derechos. Las (otras) marcas comerciales son propiedad de Thermo Fisher Scientific Inc. y sus “NG” = No Growth. Log reduction = the log amount of microorganisms eliminated, filiales. Características, condiciones y precios están sujetos a posibles cambios. Algunos productos no están disponibles en todos los países. Consulte los calculated as indicated in the text above. detalles con su representante comercial local. Alemania +49 6184 90 6000 Francia +33 2 2803 2180 Rusia +7 812 703 42 15 where they were fixed a minimum of 15 mm from the Australia +61 39757 4300 Holanda +31 76 579 55 55 Suiza +41 44 454 12 22 Table 1. Recovery of Aspergillus brasiliensis (ATCC 16404) surface. The ambient room temperature was recorded Austria +43 1 801 40 0 India +91 22 6716 2200 UK/Irlanda +44 870 609 9203 Bélgica +32 53 73 42 41 Italia +32 02 95059 552 USA/Canadá +1 866 984 3766 Cells Recovered Minimum Log Reduction and drafts, direct sunlight and heat from neighboring China +800 810 5118 or Japón +81 3 5826 1616 Location Tested equipment were eliminated. Each thermocouple took a +400 650 5118 Nueva Zelanda +64 9 980 6700 Otros países de Asia +852 2885 4613 Test 1 Test 2 Test 3 Test 1 Test 2 Test 3 España/Portugal +34 93 223 09 18 Paises Nórdicos/Bálticos/CIS Otros paises +49 6184 90 6000 measurement every 10 seconds. +358 9 329 10200 o +33 2 2803 2180 Positive Control 2.63 x 104 3.28 x 104 3.03 x 104 0 0 0 Results and Discussion Glass Door NG NG NG > 4.4 > 4.5 > 4.5 Microbiological tests ITALIAN Back Wall NG NG NG > 4.4 > 4.5 > 4.5 The results of the microbiological tests for the modified Middle Shelf NG NG NG > 4.4 > 4.5 > 4.5 thermoscientific.com Steri-Run cycle, which held at 180 °C for 45 minutes Bottom Shelf NG NG NG > 4.4 > 4.5 > 4.5 © 2013 Thermo Fisher Scientific Inc. Tutti i diritti riservati. Tutti gli (altri) marchi sono di proprietà di Thermo Fisher Scientific Inc. e delle sue filiali. Specifiche, instead of the standard 90 minutes, are shown in condizioni e tariffe possono subire variazioni. Non tutti i prodotti sono disponibili in tutti i paesi. Per maggiori dettagli consultare il rivenditore locale. Tables 1-5. In each case, no growth was found in any of Table 2. Recovery of Escherichia coli (ATCC 25922) Australia +61 39757 4300 India +91 22 6716 2200 Svizzera +41 44 454 12 22 the samples from the stainless steel coupons following the Austria +43 1 801 40 0 Italia +32 02 95059 552 UK/Irlanda +44 870 609 9203 Cells Recovered Minimum Log Reduction Steri-Run cycle, proving total elimination. The positive Belgio +32 53 73 42 41 Olanda +31 76 579 55 55 USA/Canada +1 866 984 3766 Cina +800 810 5118 or Nuova Zelanda +64 9 980 6700 Location Tested controls were treated the same as the samples except that Test 1 Test 2 Test 3 Test 1 Test 2 Test 3 +400 650 5118 Europa del Nord/CIS Altre Nazioni Asiatiche +852 2885 4613 they were not put into the incubator. The negative Francia +33 2 2803 2180 +358 9 329 10200 Nazioni non in elenco +49 6184 90 6000 4 4 4 Germania +49 6184 90 6000 Russia +7 812 703 42 15 o +33 2 2803 2180 Positive Control 2.20 x 10 2.16 x 10 2.30 x 10 0 0 0 controls showed no growth (results not shown), Giappone +81 3 5826 1616 Spagna/Portogallo +34 93 223 09 18 Glass Door NG NG NG > 4.3 > 4.3 > 4.4 demonstrating that there was no contamination of the Back Wall NG NG NG > 4.3 > 4.3 > 4.4 samples by the technicians. Three independent runs on GERMAN different days demonstrated consistency of the results. Middle Shelf NG NG NG > 4.3 > 4.3 > 4.4 thermoscientific.com Bottom Shelf NG NG NG > 4.3 > 4.3 > 4.4 Representative species of black fungal mold © 2013 Thermo Fisher Scientific Inc. Alle Rechte vorbehalten. Alle (anderen) Warenzeichen sind Eigentum von Thermo Fisher Scientific Inc. bzw. nationalen (A. brasiliensis), bacteria (E. coli) and mycoplasma, a Niederlassungen. Änderungen von Spezifikationen, Bedingungen und Preisen vorbehalten. Nicht alle Produkte sind in allen Ländern erhältlich. Ausführliche Informationen erhalten Sie von Ihrem Thermo Fisher Scientific Ansprechpartner. Table 3. Recovery of Mycoplasma pneumoniae (ATCC 15531) common contaminant that is difficult to eradicate from cultures (M. pneumoniae), all provide proof of broad Australien +61 39757 4300 Indien +91 22 6716 2200 Russland +7 812 703 42 15 Cells Recovered Minimum Log Reduction efficacy of the Steri-Run cycle. More importantly, total Belgien +32 53 73 42 41 Italien +32 02 95059 552 Spanien/Portugal +34 93 223 09 18 Location Tested China +800 810 5118 or Japan +81 3 5826 1616 Schweiz +41 44 454 12 22 Test 1 Test 2 Test 3 Test 1 Test 2 Test 3 elimination of B. atrophaeus shows that the Steri-Run +400 650 5118 Niederlande +31 76 579 55 55 UK/Irland +44 870 609 9203 cycle meets the standard of sterilization for dry heat. Deutschland nationale kostenlose Hotline Neuseeland +64 9 980 6700 USA/Kanada +1 866 984 3766 Positive Control 1.18 x 106 1.25 x 106 1.33 x 106 0 0 0 0800 1 536 376 Nordeuropa/Baltikum/CIS Further, the total elimination of the highly heat-resistant Deutschland international +358 9 329 10200 Andere asiatische Länder +852 2885 4613 Glass Door NG NG NG > 6.1 > 6.1 > 6.1 G. stearothermophilus, the biological indicator for +49 6184 90 6000 Österreich +43 1 801 40 0 Andere Länder +49 6184 90 6000 Frankreich +33 2 2803 2180 oder +33 2 2803 2180 Back Wall NG NG NG > 6.1 > 6.1 > 6.1 autoclave sterilization, provides an additional level of Middle Shelf NG NG NG > 6.1 > 6.1 > 6.1 assurance. Elimination of 6-7 logs of these highly resistant microorganisms meets the minimum standards FRENCH Bottom Shelf NG NG NG > 6.1 > 6.1 > 6.1 for sterilization, but this was achieved in half the normal thermoscientific.com holding time of 90 minutes at 180 °C, meeting the U.S. Table 4. Recovery of Bacillus atrophaeus endospores (ATCC 51189) © 2013 Thermo Fisher Scientific Inc. Tous droits réservés. Les (autres) marques déposées sont des marques commerciales ou déposées de Thermo Fisher Pharmacopeia requirements for a total 12-log reduction Scientific Inc et de ses filiales. Les caractéristiques, conditions et tarifs sont susceptibles d’être modifiés. Tous les produits ne sont pas disponibles dans tous les Cells Recovered Minimum Log Reduction when the full 90 minute cycle is employed. pays. Pour tout renseignement, veuillez vous adresser à votre distributeur local. Location Tested Test 1 Test 2 Test 3 Test 1 Test 2 Test 3 Allemagne +49 6184 90 6000 France +33 2 2803 2180 Russie +7 812 703 42 15 Australie +61 39757 4300 Inde +91 22 6716 2200 Suisse +41 44 454 12 22 6 6 6 Positive Control 2.48 x 10 6.05 x 10 1.95 x 10 0 0 0 Autriche +43 1 801 40 0 Italie +32 02 95059 552 UK/Irlande +44 870 609 9203 Belgique +32 53 73 42 41 Japon +81 3 5826 1616 USA/Canada +1 866 984 3766 Glass Door NG NG NG > 6.4 > 7.8 > 6.3 Chine +800 810 5118 or Nouvelle-Zélande +64 9 980 6700 Back Wall NG NG NG > 6.4 > 7.8 > 6.3 +400 650 5118 Pays Bas +31 76 579 55 55 Autres pays d’Asie +852 2885 4613 Espagne/Portugal +34 93 223 09 18 Pays nordiques/baltes/CEI Autres Pays +49 6184 90 6000 Middle Shelf NG NG NG > 6.4 > 7.8 > 6.3 +358 9 329 10200 ou +33 2 2803 2180 Bottom Shelf NG NG NG > 6.4 > 7.8 > 6.3

Table 5. Recovery of Geobacillus stearothermophilus endospores (ATCC 12980) thermoscientific.com

Cells Recovered Minimum Log Reduction © 2013 Thermo Fisher Scientific Inc. All rights reserved. All (other) trademarks are the property of Thermo Fisher Scientific Inc. and its subsidiaries. Specifications, Location Tested terms and pricing are subject to change. Not all products are available in all countries. Please consult your local sales representative for details. Test 1 Test 2 Test 3 Test 1 Test 2 Test 3 Australia +61 39757 4300 India toll free 1800 22 8374 Russia +7 812 703 42 15 Positive Control 2.66 x 106 8.58 x 106 3.18 x 106 0 0 0 Austria +43 1 801 40 0 India +91 22 6716 2200 Spain/Portugal +34 93 223 09 18 Belgium +32 53 73 42 41 Italy +32 02 95059 552 Switzerland +41 44 454 12 22 Glass Door NG NG NG > 6.4 > 6.9 > 6.5 China +800 810 5118 or Japan +81 3 5826 1616 UK/Ireland +44 870 609 9203 +400 650 5118 Netherlands +31 76 579 55 55 USA/Canada +1 866 984 3766 Back Wall NG NG NG > 6.4 > 6.9 > 6.5 France +33 2 2803 2180 New Zealand +64 9 980 6700 Middle Shelf NG NG NG > 6.4 > 6.9 > 6.5 Germany national toll free 0800 1 536 376 Nordic/Baltic/CIS countries Other Asian countries +852 2885 4613 Germany international +49 6184 90 6000 +358 9 329 10200 Countries not listed +49 6184 90 6000 Bottom Shelf NG NG NG > 6.4 > 6.9 > 6.5

SPANISHFigure 4: Typical temperature map for full Steri-Run cycle. Steri-Run cycle, which holds at 180 °C for 90 minutes 5 thermoscientific.comThermocouples were place in 47 locations in the chamber, (instead of the 45 minutes tested here), is designed to including the walls, glass door, water reservoir cover and floor, and achieve a true 12-log SAL, meeting the standards for ©3 2013 shelves. Thermo FisherAll areas Scientific reached Inc. Reservados a minimum todos los derechos. of 180 Las °C. (otras) N =marcas 2 x comerciales4 units. son propiedad de Thermo Fisher Scientific Inc. y sus filiales. Características, condiciones y precios están sujetos a posibles cambios. Algunos productos no están disponiblesthe overkill en todos los method países. Consulte to los prove sterilization. detalles con su representante comercial local. TemperatureTemperature Map Map - Thermo- Thermo ScientificScientific™ ™Steri Steri-Run-Run™ Cycle™ Cycle The PHE tests of the modified Steri-Run cycle showed 210 Alemania210 +49 6184 90 6000 Francia +33 2 2803 2180 eliminationRusia +7 of812 common 703 42 15 cell culture contaminants Australia +61 39757 4300 Holanda +31 76 579 55 55 Suiza +41 44 454 12 22 190190 Austria +43 1 801 40 0 India +91 22 6716 2200 (A. brasiliensisUK/Irlanda +44, E. 870 coli 609 ,9203 and M. pneumoniae), and Bélgica170170 +32 53 73 42 41 Italia +32 02 95059 552 even heat-resistantUSA/Canadá +1 866 bacterial 984 3766 endospores (B. atrophaeus China +800 810 5118 or Japón +81 3 5826 1616 +400150 650150 5118 Nueva Zelanda +64 9 980 6700 and G.Otros stearothermophilus países de Asia +852 2885) 4613used for validation of C) España/Portugal° +34 93 223 09 18 Paises Nórdicos/Bálticos/CIS +49 6184 90 6000 130130 sterilizationOtros paises in dry heat sterilizers and +358 9 329 10200 o +33 2 2803 2180 110110 (respectively). The extensive temperature mapping Temperature ( Temperature 9090 showed that all areas are designed to hold lethal Temperature (ºC) Temperature ITALIAN7070 temperatures for double the time required to eliminate

50 microorganisms in the PHE tests. thermoscientific.com50 3030 © 2013 Thermo0 Fisher Scientific22 Inc. Tutti4 i diritti riservati.66 Tutti gli (altri)8 marchi sono 1010di proprietà di 12Thermo12 FisherExperienced Scientific Inc. e dellecell sue culturists filiali. Specifiche, understand that battling TimeTime (hours) (hours) condizioni e tariffe possono subire variazioni. Non tutti i prodotti sono disponibili in tutti i paesi. Per maggiori dettaglithese consultare common il rivenditore contaminants locale. is an ongoing challenge. The Steri-Run cycle offers a new tool in the battle for AustraliaTemperature +61 39757 mapping4300 India +91 22 6716 2200 Svizzera +41 44 454 12 22 Austria +43 1 801 40 0 Italia +32 02 95059 552 qualityUK/Irlanda cell culture +44 870 results. 609 9203 A Thermo Scientific CO2 BelgioIn validating +32 53 73 42 sterilization, 41 it is criticalOlanda to +31not 76 only 579 55 reach 55 a incubatorUSA/Canada featuring +1 866 the 984 Steri-Run3766 cycle assures total, Cina +800 810 5118 or Nuova Zelanda +64 9 980 6700 +400temperature 650 5118 that is known to eliminateEuropa microorganisms,del Nord/CIS uniformAltre sterilization Nazioni Asiatiche of +852 all 2885chamber 4613 surfaces. With the Franciabut to +33 provide 2 2803 2180evidence that all areas+358 in 9 329multiple 10200 units push ofNazioni a button, non in elenco the simple+49 6184 overnight90 6000 routine provides Germania +49 6184 90 6000 Russia +7 812 703 42 15 o +33 2 2803 2180 Giapponeachieve +81 and 3 5826hold 1616 this temperature.Spagna/Portogallo This is because +34 if 93 some 223 09 18 fast, easy elimination of microbial contaminants and areas are not heated to a high enough temperature, some eliminates the need for separate autoclaving of parts GERMANresistant microorganisms in those areas could survive. and use of potentially toxic germicides. thermoscientific.com Eight tests with 47-point temperature mapping were References ©performed. 2013 Thermo Fisher The Scientific average Inc. Alle Rechteresults vorbehalten. are shownAlle (anderen) in Warenzeichen Figure sind4. Eigentum von1. Thermo European Fisher Scientific Directorate Inc. bzw. nationalen for the Quality of Niederlassungen.At time zero, Änderungen the vonstandard Spezifikationen, Steri-Run Bedingungen undcycle Preisen was vorbehalten. initiated Nicht alle Produkte sind& in allenHealthCare, Ländern erhältlich. Council Ausführliche of Europe. European Informationen erhalten Sie von Ihrem Thermo Fisher Scientific Ansprechpartner. from 37 °C, with the temperature rising to 180 °C over Pharmacopoeia, 8th ed. Strasbourg France, 2014. Australienapproximately +61 39757 24300 hours. As shown,Indien some +91 areas 22 6716 reached 2200 Russland +7 812 703 42 15 2. The United States Pharmacopeial Convention. The Belgien180 °C +32 faster 53 73 42 than 41 others, but all 47Italien locations +32 02 95059 held 552 at Spanien/Portugal +34 93 223 09 18 China +800 810 5118 or Japan +81 3 5826 1616 UnitedSchweiz States +41 Pharmacopeia44 454 12 22 , 37th Ed. Rockville MD, +400180 650°C 5118 for a minimum of 90 minutes.Niederlande Many +31 areas 76 579 55 55 UK/Irland +44 870 609 9203 United States. 2014. Deutschlandshowed temperatures nationale kostenlose considerably Hotline Neuseeland higher than+64 9 980180 6700 °C. USA/Kanada +1 866 984 3766 0800 1 536 376 Nordeuropa/Baltikum/CIS DeutschlandOf interest, international the entire chamber was+358 at 9160 329 10200 °C or above 3. PublicAndere Health asiatische England. Länder +852 An 2885evaluation 4613 of the +49for 6184greater 90 6000 than 3 hours. Some sources,Österreich including +43 1 801 40 the 0 effectivenessAndere Länder of +49the 6184 sterilization 90 6000 cycle of the Thermo Frankreich +33 2 2803 2180 oder +33 2 2803 2180 America Dental Association4, Centers for Disease Scientific™ CO2 incubator with the Thermo Scientific Control5 and the World Health Organization6, have ™ FRENCH Steri-Run cycle. Report No. 14/036, 2014. Test recommended dry heat sterilization at 160 °C for 2-3 services paid for by Thermo Fisher Scientific. thermoscientific.comhours. This extensive temperature mapping of multiple 4. American Dental Association. Sterilization and units (8 total tests) provides clear proof that the Steri- © 2013 Thermo Fisher Scientific Inc. Tous droits réservés. Les (autres) marques déposées sont des marques commercialesdisinfection ou déposées of dedental Thermo Fisherinstruments. 2004, updated 2009. ScientificRun cycle Inc et de reaches ses filiales. Lesand caractéristiques, holds at conditions 180 et°C tarifs in sont all susceptibles areas. d’être modifiés. Tous les produits ne sont pas disponibles dans tous les pays. Pour tout renseignement, veuillez vous adresser à votre distributeur local. 5. Centers for Disease Control and Prevention, Department Conclusions of Health and Human Services. Guideline for Disinfection AllemagneThree separate +49 6184 90tests 6000 at PHE provedFrance that +33 a 2Thermo 2803 2180 Russie +7 812 703 42 15 Australie +61 39757 4300 Inde +91 22 6716 2200 and SterilizationSuisse +41 44 454 in 12 Health 22 Care Facilities. 2008. AutricheScientific +43 1 801CO2 40incubator 0 with the ItalieSteri-Run +32 02 95059 automated 552 UK/Irlande +44 870 609 9203 Belgiquehigh temperature +32 53 73 42 41 sterilization cycleJapon achieved +81 3 5826 total 1616 6. WorldUSA/Canada Health +1 Organization. 866 984 3766 The International Chine +800 810 5118 or Nouvelle-Zélande +64 9 980 6700 +400sterilization, 650 5118 completely eliminatingPays more Bas +31 than 76 579 6 55logs 55 PharmacopoeiaAutres pays d’Asie. Fourth +852 2885 Edition, 4613 2014. Espagne/Portugal(>1 x 106) of +34approved 93 223 09 biological18 Paysindicator nordiques/baltes/CEI organisms Autres Pays +49 6184 90 6000 +358 9 329 10200 ou +33 2 2803 2180 in half the normal sterilization time. Thus, the standard

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Australia +61 39757 4300 India toll free 1800 22 8374 Russia +7 812 703 42 15 Austria +43 1 801 40 0 India +91 22 6716 2200 Spain/Portugal +34 93 223 09 18 Belgium +32 53 73 42 41 Italy +32 02 95059 552 Switzerland +41 44 454 12 22 China +800 810 5118 or Japan +81 3 5826 1616 UK/Ireland +44 870 609 9203 +400 650 5118 Netherlands +31 76 579 55 55 USA/Canada +1 866 984 3766 France +33 2 2803 2180 New Zealand +64 9 980 6700 Germany national toll free 0800 1 536 376 Nordic/Baltic/CIS countries Other Asian countries +852 2885 4613 Germany international +49 6184 90 6000 +358 9 329 10200 Countries not listed +49 6184 90 6000

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