Int Browne Brochure (Page 1)
Contents
1. Browne recommends the use of TST Control Cycle Verification Emulating Indicators for monitoring porous load steam a b sterilization processes Time to go Green mins Type 4 Tubes Unsafe zn Temp C Time mins 150 85 80 160 45 Conform to 70 T EN867 1 Class Di 60 igo e ISO 11140 1 Class 4 2 50 40 30 20 Effective and immediate visual check on 10 sterilization conditions F Effective Cycle g i g e Integrated 2 criteria control of les a is RNE ASO E Temp temperature and time e Ideal for fluid and dry heat sterilizers a gt Select the Control Tube to match your Time to go Green mins Type 5 Tubes sterilization parameters a rer Temp C Time mins time temperature and distribute them me 160 throughout the load prior to sterilization nae ee z 140 120 100 80 60 NG 40 150 C 160 C 170 C 180 C Temp K Chemical Indicators amp Accessories from Albert Browne International Ltd 11 12 Assurance BROWNE Technology P ra Multi Parameter Multi Parameter Multi Parameter Indicators Indicators Indicators nH Emen Formaldehyde Control Indicators MVI Ethylene Oxide Indicator MVI Steam Indicator Order Code ZEED Order code GX Order code GX 100 indicators box 250 indicators box White to purple colour change 250 indicators box Conform to Conform to Order code EExD EN867 1 Class Di EN867 1 Class D 1 White to black colour change ISO 11140 1 Class 4 2 ISO 1112. by implication that air and other non condensable gases have been A Bowie Dick type test is an accepted effectively removed The chemical Fail air method of testing the steam penetration indicator sheet at the centre of the pack and air removal capability of a vacuum shows a defined colour change from sterilizer yellow to dark blue purple when exposed to a specific combination of time temperature and steam When there is no air or other non condensable gases in the chamber steam will Fail NCGs penetrate the pack rapidly and completely and the indicator will show a uniform colour change When air or other non condensable gases are present they will collect towards the centre of the pack as an air gas pocket which will impair contact between the steam and the Fail wet steam indicator sheet The temperature or moisture level or both will be lower in the region of the air gas pocket and will result in a non uniform colour change of the indicator distinct yellow markings will be evident on the sheet Fail super heat lt a Chemical Indicators amp Accessories from Albert Browne International Ltd Pass Albert Browne Ltd was the first company in the world to attain the BSi Kitemark for Bowie Dick test packs British Standards Institution not only undertook the independent testing but also examined all the necessary production control systems in place to ensure consistency of manufacture This arguably ma
3. 15011138 13 Browne Bio Monitors contain a stated population of bacterial spores inoculated onto filter paper and placed inside a plastic culture tube A crushable glass ampoule contains the culture medium for release after exposure to the sterilization process Each box contains a certificate including Culture collection number Lot number Expiry Date Spore Population Resistance data Exposure in Biological Indicator Evaluation Resistometer BIER Browne Bio Monitors for a steam process contain the spores of Geobacillus stearothermophilus and have an external chemical indicator on the label This changes from green to blue grey when sterilization exposure has occurred The Bio Monitor should be incubated at 57 C for no longer than 48 hours following exposure and the results read approximately every 12 hours If spores survive the sterilization cycle the culture medium will turn to yellow positive If the spores have been killed the culture medium will retain the original purple colour Browne Bio Monitors for an ethylene oxide process contain the spores of Bacillus atrophaeus and have an external chemical indicator on the label This changes from light blue to tan when sterilization exposure has occurred The Bio Monitor should be incubated at 37 C for no longer than 48 hours following exposure and the results read approximately every 12 hours If spores survive the sterilization cycle the culture medi
4. Custom Control Tubes 7 Fluid or Dry Heat Sterilization For cycles different to those specified 100 C 105 C 110 C 115 C 120 C 125 C 130 C Temp above Browne can manufacture Control Tubes to meet your specific time temperature parameters a Sk EN Using the same clear red to clear green Time tis go Gr ani mins Type 2 Tubes Sterilization Control Tubes colour scale verification as the standard 100 aoe f tubes they will provide an immediate 90 Pe r esl Type 1 Black spot visual check for your specific 80 o be Product Code ELF sterilization cycle i 115 15 i ili i 120 9 Puig Sterilization 1 litre of the solution can be 50 125 5 5 121 C 15 mins manufactured and stored on our premises 40 130 3 5 Type 2 Yellow spot for up to 12 months This is sufficient Product Code fp quantity for approximately 50 boxes of x Steam Sterilization tubes and can be called off when 134 C 3 mins required Please contact us to discuss 100 C 105 C 110 C 115 C 120 C 125 C 130 C Temp Type 3 Green spot your individual requirements Product Code gfik Dry Heat Sterilization 4 D 160 C 60 mins Colour Scale T me to go Green mins Type 3 Tubes Type 4 Blue spot isok Temp C Time mins 145 158 Product Code ge Z3 160 ae is Dry Heat Sterilization eal 160 e0 i 120 f 180 C 12 mins all 1657 a Type 5 White spot sof TE Product Code GELB Unused Go Dry Heat Sterilization 7 i 160 C 120 mins 180 C 35 mins 140 C 150 C 160 C 170 C 180 C Temp
5. EN 867 1 Class A ISO 11140 1 Class 1 indicators for steam ethylene oxide formaldehyde or gamma electron beam e Choice of colour change for steam indicators pink to dark brown or colourless to black Please contact us to discuss your requirements Chemical Indicators amp Accessories from Albert Browne International Ltd ACE Process Indicators Process Indicator Autoclave Tape Dry heat Order code FZT 19mm 3 4 x 50m 48 rolls per carton Steam Order code A 18mm 3 4 x 50m 48 rolls per carton Steam Order code FEE 24mm 1 x 50m 36 rolls per carton Steam Hi Tack Order code 18mm 3 4 x 50m 48 rolls per carton Ethylene Oxide Order code 18mm 3 4 x 50m 48 rolls per carton Plain Order code D 18mm 3 4 x 50m 48 rolls per carton Plain Order code CYP 24mm 1 x 50m 36 rolls per carton Conform to EN 867 1 Class A 1 ISO 11140 1 Class 1 2 Traditional process indicator tape allows identification of processed from unprocessed items at a glance The easily recognisable stripes change colour when exposed to the specific sterilant verifying exposure to the process without the need to open packs or check records Dry Heat Process Indicator tape is specially formulated to withstand the high temperatures experienced during dry heat sterilization while still maintaining excellent adhesive qualities The green indicator ink changes colour to brown when exposed to t
6. Tubes Type 2 Yellow Spot 1349 3 mins 7302 Browne Control Tubes Type 3 Green Spot Dry Heat Sterilization 1609 60 mins 7303 Browne Control Tubes Type 4 Blue Spot Dry Heat Sterilization 180 12 mins 7304 Browne Control Tubes Type 5 White Spot Dry Heat Sterilization 160 120 mins amp 1800 35 mins 7305 gt Z04 LNI 66 007Z
7. been reached giving the end user assurance that adequate sterilizing conditions occurred at point of placement Ethylene Oxide Integrators will show a fail if the relative humidity level gas concentration temperature or duration of exposure fall outside of the specified limits 900mg Concentration mg per litre Temperature 55 C 37 C Time 20 55 minutes Humidity 40 60 600mg Concentration mg per litre Temperature 55 C 37 C Time 35 70 minutes Humidity 40 60 It is recommended that Browne Ethylene Oxide Process Detector Order Code 2421 Spots are placed on the outside of each pack to allow processed and unprocessed items to be identified at a glance Note however that the spots are not calibrated for use as an in pack control indicator Chemical Indicators amp Accessories from Albert Browne International Ltd 13 14 Assurance BROWNE Technology 5 3 Cycle Verification Emulating Indicators pC y Cycle Verification Emulating Indicators Des Check Order Code ZIX 73 C 12 minutes 100 indicators box Order Code 93 C 10 minutes 100 indicators box Conform to EN867 1 Class Di1 ISO 11140 1 Class 6 2 Cycle verification indicators for use in moist heat processes The Des Check range provides an accurate convenient method of routine control for moist heat processes When distributed through out the load the indicators provide
8. results e Sensor Technology Free from the lead Pass and heavy metal salts traditionally A U u heat e Seam associated with Bowie Dick test sheets pen etaton pila lt Lebel and Oo M i the Browne Sensor test sheet is safe to confirms by implication that air and other handle and easy to dispose of non condensable gases have been Fail removed Detailed instructions for running a standard cotton sheet Bowie Dick test are included with the Sensor sheets Browne Plain Cotton sheets for use with ot the Sensor sheet are available on order code 9053 Please refer to the relevant N page of this catalogue for further details Ni Chemical Indicators amp Accessories from Albert Browne International Ltd Ze pe Specific Use Indicators i HY Bowie Dick Lead Free Test Sheet Order Code CHB 50 sheets folder Conforms to EN867 3 Class Bye ISO 11140 1 Class 2 2 The Browne Bowie Dick test sheet incorporates patented MVI technology Free from the lead and heavy metal salts that have traditionally been associated with Bowie Dick test sheets the Browne Bowie Dick test sheet is safe to handle and easy to dispose of The colourless indicator sheet turns to a uniform deep purple when exposed to rapid and even steam penetration However should the sheet be exposed to an inadequate Bowie Dick cycle inefficient air removal the presence of an air leak or other non condensable gas a clearly visible fail wil
9. systems the left hand section is pre printed with a Class A process indicator while the right hand section incorporates a Class 6 cycle verification indicator using Browne s unique TST Control technology During packing both sections are printed with bar coded pack data using the The right hand section is then placed inside the pack affixed to the tray list if appropriate while the left hand section is attached to the outside of the tray pack or pouch in the usual way At point of use the right hand section is retrieved from the tray pack or pouch and reapplied into the patient s notes as evidence of an effective sterilization cycle existing computerised traceability system Chemical Indicators amp Accessories from Albert Browne International Ltd 15 16 Assurance BROWNE Technology je OM Biological Indicators Bio Monitors Steam Processes 105 Order Code 2EPD 100 units per box Steam Processes 106 Order Code E 100 units per box Ethylene Oxide Processes Order Code PEE 100 units per box Biological Indicators Low Temp Steam amp Formaldehyde Process Order Code E 100 units per box Accessories Recovery Medium for LTSF Biological Indicators Order code 12 units per box Dual Temperature Incubator 37 57 C Order code single unit Browne Bio Monitors conform to the US Pharmacopeia XXIII and AAMI ANSI standards EN866 12 and
10. 0 indicators S Accessories Browne Recovery Medium for LTSF Biological Indicators is contained in a 28ml glass bottle with polypropylene screw top lid and not less than 15ml modified Tryptone Soya Broth Please contact your Browne representative for order information Browne Dual Temperature Incubator 37 57 C features 14 incubating cavities optional thermometer cavity power on light and temperature selector switch Please contact your Browne representative for order information Chemical Indicators amp Accessories from Albert Browne International Ltd h References 10 prEN ISO 15883 1 2002 1 EN 867 1 1997 Washer disinfectors Part 1 General Non biological systems for use in requirements and tests sterilizers Annex E Part 1 General requirements 11 Health Technical Memorandum 2 ISO 11140 1 1995 HTM 2030 Washer Disinfectors Sterilization of health care products Validation and verification Chemical indicators Guidance Document issued by NHS Part 1 General requirements Estates An Executive Agency of the Department of Health UK 3 EN 867 4 1997 Non biological systems for use in sterilizers a EA testing sterilizers Peri as Specife Gor inelceisers asan and sterilization processes alternative to the Bowie and Dick test i for the detection of steam penetration Part1 General requirements Part 7 Particular requirements for self contained biological indicator
11. 244 100 units per box Bio Monitor Ethylene Oxide 2233 100 units per box Bio Monitor Steam 106 2236 100 units per box Bio Monitor Steam 10 2232 12 units per box Recovery Medium for LTSF Biological Indicators 2231 100 units per box Biological Indicator for LTSF 2230 Product Index Process indicators amp Accessories Box Quantity Description Order code 250 spots per box Formaldehyde Process Detector Spots 2402 1000 spots per box Ethylene Oxide Process Detector Spots 2421 1000 spots per box Gamma Check Irradiation Detector Spots 3301 1000 labels per reel Gamma Check Irradiation Detector Labels 3303 48 rolls per carton Dry Heat Indicator Tape 19mm 3 4 x 50m 0140 48 rolls per carton Steam Indicator Tape 18mm 3 4 x 50m 0142 36 rolls per carton Steam Indicator Tape 24mm 1 x 50m 0143 48 rolls per carton Steam Indicator Tape Hi Tack blue 18mm x 50m 0147 48 rolls per carton Plain Masking Tape 18mm 3 4 x 50m 0160 36 rolls per carton Plain Masking Tape 24mm 1 x 50m 0161 Please call Process Indicator Labels various Please call Specific Test Indicators amp Accessories Box Quantity Description Order code 20 packs per box TST Bowie Dick test pack for sterilizers working at 134 C 137 C up to 3 5 mins 2352 20 packs per box TST 121 Bowie Dick test pack for sterilizers working at 121 C 124 C 8 8 3 mins 2310 10 packs per box TST Bowie Dick Dick test pack for Eschmann Little Sister 3 Vacuum amp SES 2000 Vacuum 2
12. 358 10 packs per box TST Bowie Dick test pack for Prestige Century 22 16 amp 11 litre 2365 20 packs per box TST Bowie Dick test pack Getinge GE 224 C Vac amp Citomat 164 V 6536 10 packs per box TST Bowie Dick test pack for W amp H Lisa MB 17 22 2356 20 packs per box TST Bowie Dick test pack for Matachana M20 B 2352 1 helix 250 indicators TST Helix for daily steam penetration test in Type B small steam sterilizers 3780 50 sheets per folder Sensor Sheet for use in standard towel pack 2385 36 sheets per box Plain cotton sheets for use in standard towel pack 9053 50 sheets per folder Lead Free Bowie Dick Test sheet 2561 10 pots per box Washer disinfector test soil 2304 100 per box STF Load Check Indicators 2315 Single item STF Load Check holder 2316 4 tests per box Ninhydrin Protein Detection Test 2370 Single item Dual Temperature Incubator 37 C 57 C 2244 Box Quantity 100 indicators per box 200 indicators per box 250 500 indicators per box 250 500 indicators per box 250 500 indicators per box 100 tubes per box 100 tubes per box 100 tubes per box 100 tubes per box 100 tubes per box Multi parameter Indicators amp Accessories Description Order code Formaldehyde Control Indicators 2401 Vapour Strip 2500 MVI Steam Indicator White to Purple 2560 MVI Ultra Steam Indicator White to Black 2551 MVI Ethylene Oxide Indicator 2563 Browne Control Tubes Type 1 Black Spot Fluid Sterilization 1219 15 mins 7301 Browne Control
13. 40 1 Class 4 2 250 indicators box Formaldehyde Control Indicators should When placed inside trays packs or Conform to be used inside each pack to show that pouches MVI Ethylene Oxide Indicators EN867 1 Class D1 Low Temperature Steam and will confirm that the gas has penetrated ISO 11140 1 Class 4 2 Formaldehyde gas LTSF has penetrated to the point of placement Changing from the pack in a sufficient quantity and for bright orange to vivid red end users the correct length of time for sterilization have clear visual reassurance of exposure When placed inside trays packs or to occur to an ethylene oxide sterilization process pouches MVI Steam Indicators will The control indicator turns from blue to a P i confirm that steam has penetrated to the complete green when adequate sterilizing MVI Ethylene Oxide Indicators Can be point of placement With a choice of conditions have been reached Poea current ethylene oxide colour change from white to purple or sterilization processes Its recommended that Browne e e arest Formaldehyde Process Detector Order Lead free and non toxic this advanced sterilization process z Code 2402 Spots are placed on the ink technology is both safe to use and STAS OF Rach PACI TOA lOW Proce ara environmentally friendly Browne MVI Steam Indicators can be and unprocessed items to be identified at asl inal eces randina from 1209C a glance Note that the spots are not o y angmga calibrated to be used as an i
14. Assurance BROWNE Technology Chemical Indicators amp Accessories from Albert Browne International Ltd Assurance BROWN through Technology The Browne range of chemical indicators has been categorised into six areas broadly defined by intended use They are also colour coded for easy identification Process Indicators Specific Use Indicators Multi Parameter Indicators Integrating Indicators Cycle Verification LON 2 Indicators Biological Indicators What are Chemical Indicators Perhaps the simplest analogy for a chemical indicator is one found in nature if planted in alkaline soil the blooms of a hydrangea will be pink conversely if planted in acid soil the blooms will be blue So by way of a simple display of colour the hydrangea is providing information about its immediate environment it is indicating the pH of its surrounding soil This is a very simplistic analogy and of course the Browne range of chemical indicators provides much more information than an indication of the surrounding pH There are similarities however as they do provide information about their immediate surroundings by way of an easily interpreted colour change Assurance BROWN through Technology Browne Chemical Indicators Most of the products are designed for use during the different stages of a decontamination process cleaning disinfection and sterilization and are available for most ty
15. e removal of the dried test soil peptides and protein residues present pattern from the plastic substrate and show a purple discolouration should provides a qualitative assessment of the the swab be contaminated washer disinfector cleaning performance The test kit also contains vials of ninhydrin reagent to perform positive and negative controls during each test Detailed instructions for use are supplied with every box and further guidance can be obtained from e UK guidance document HTM 2030 Washer disinfectors Validation and verification e prEN 15883 1 2002 Washer disinfector Annex E Ne Chemical Indicators amp Accessories from Albert Browne International Ltd a g Dry Heat Time Temperature Graphs VC place the tubes closely beside or inside the most inaccessible articles to be va i sterilized Multi Parameter i a Time to go Green mins Type 1 Tubes A Fluids i Temp C Time mins Indicators place a control tube in a test bottle of the K 100 100 solution to be sterilized and place in the ie r j centre of the sterilization chamber 60 we z Instructions for use and colour guides are a ba ae included with each box
16. ensor sheet has been calibrated for Validation and routine control of use in the standard towel pack as sterilization by moist heat specified in EN285 1997 7 and in UK Porous load autoclaves must be tested Guidance Document HTM 2010 g It is periodically to check that the amount of designed to detect failures where the non condensable gas remaining in the temperature in the centre of a standard sterilization chamber after the air towel pack is 2 C cooler than the removal phase will not impair the chamber drain at the start of the effectiveness of steam penetration into sterilization plateau the load to be sterilized If the sterilizer achieves complete air removal and rapid steam penetration into the centre of the towel pack the Sensor sheet will indicate a pass i e the pale The Browne TST Helix is a Hollow Load Strong colours High definition ae sheets hile Shenae elOey eae Process Challenge Device PCD as Easy to read Me green CHOUN defined in EN 867 5 and has been In the event of failure the presence of developed and validated for testing the air or other non condensable gas is air removal steam penetration sensed by a chemical reaction The capability of small Type B steam a Sensor sheet will demonstrate a fail sterilizers only pattern i e a yellow or brown will be i 7 f Unused clearly visible Use in any other sterilizer or with any other type of indicator may give The Browne Sensor sheet incorporates dangerously misleading
17. er code 200 indicators per box Des Check 73 C 12 mins previously known as LTSD Indicators 2460 200 indicators per box Des Check 93 C 10 mins 2470 200 indicators per box TST Control Indicators 134 C 3 5 mins Flash 2317 100 indicators per box TST Control Indicators 134 C 3 5 mins 2340 100 indicators per box TST Control Indicators 134 C 3 5 mins Self Adhesive 3727 100 indicators per box TST Control Indicators 134 C 4 mins amp 121 C 12 mins 2341 200 indicators per box TST Control Indicators 134 C 5 3 mins amp 121 C 15 mins 2302 100 indicators per box TST Control Indicators 134 C 5 3 mins amp 121 C 15 mins 2342 100 indicators per box TST Control Indicators 121 C 15 mins 2347 100 indicators per box TST Control Indicators 134 C 5 3 mins amp 121 C 15 mins Self Adhesive 3726 200 indicators per box TST Control Indicators 134 C 7 mins amp 121 C 20 mins Self Adhesive 3725 200 indicators per box TST Control Indicators 134 C 7 mins amp 121 C 20 mins 3760 200 indicators per box TST Control Indicators 134 C 9 mins 3702 200 indicators per box TST Control Indicators 134 C 18 mins 3706 1500 per reel TST Control Multi part Label 134 C 3 5 mins 5006 200 indicators per box TST Control Duplex Label 134 C 3 5 mins 5017 Browne Biological Indicators amp Accessories Box Quantity Description Order code Single item Dual Temperature Incubator 37 C 57 C 2
18. est procedures defined in relevant standards and guidance documents and in monitoring defined stages of a process that would otherwise be difficult to routinely assess Mechanical equipment used throughout the decontamination process will have undergone validation before being sanctioned for daily use Most machines equipped with electronic or mechanical sensors to record specific aspects of the machines activity These sensors are connected to monitoring and recording gauges graphical charts and digital displays that provide fundamental information on the machine s performance Although providing vital information on the machine s mechanical activity they cannot provide monitoring of the physical conditions occurring inside the chamber of the machine Furthermore between scheduled maintenance visits these sensors monitors and recorders can lose calibration Browne specific use indicators can help resolve these two issues by providing supplementary data on critical aspects stages of a process a 2 Chemical Indicators amp Accessories from Albert Browne International Ltd TOD Multi Parameter Indicators Browne Multi Parameter Indicators are the first of three types of indicator available for in pack monitoring and like the others are placed inside each tray pack or pouch before processing These indicators will change colour when exposed to the sterilant disinfectant providing users wit
19. h clear visual reassurance that the agent has penetrated to the point of placement in each tray pack or pouch The explanation below will help but if you have any questions please do not hesitate to contact us or your local Browne representative O Integrating Indicators Browne Integrating Indicators are the second of three types of indicator available for in pack monitoring and like the others are placed inside each tray pack or pouch before processing The indicators will change colour when exposed to a sterilant disinfectant in sufficient quantity or duration to inactivate the equivalent challenge presented by a defined and stated test organism This provides users with clear visual reassurance that the agent has penetrated to the point of placement in each tray pack or pouch AS Cycle Verification Indicators Browne Cycle Verification Emulating Indicators are the third of three types of indicator available for in pack monitoring Cycle Verification Indicators provide the most specific information of any chemical indicator available and like the others are placed inside each tray pack or pouch before processing The primary difference between these and other chemical indicators is their cycle specificity All conform to the ISO 11140 1 classification as Class 6 indicators which means that each product will have been calibrated to perform to the predefined
20. he dry heat process Steam Process Indicator Tape is a packaging tape with steam sensitive indicator ink The high contrast colour change is designed to show at a glance that the pack has been exposed to a steam sterilization process Manufactured from treated crepe paper and coated with high performance cross linked pressure sensitive adhesive the tape securely bonds to paper plastics non wovens board metal glass and linen The hi tack version is as above but incorporating a stronger adhesive to adhere to treated paper wrap This is not recommended for use with textiles as it can leave a residue The tape is blue in colour Plain tape is similar to steam indicator tape but without the stripes Designed as a packaging tape but with special adhesive qualities to withstand steam sterilization IMPORTANT Please remember to confirm the tape dimensions when ordering Chemical Indicators amp Accessories from Albert Browne International Ltd 5 6 Assurance BROWNE 2 Technology ie E The unique combination of advanced 4LON 4AL0 thermo chromic technology and the original Bowie Dick concept checks not Specific Use Indicators Specific Use Indicators Adna r a ehea Pa steam supply So when the Browne TST Bowie Dick Type Test Pack does detect a fail the distinctive results generated by g PO the TST indicator sheet can help diagnose es il TST Tem TST a a ma
21. ictate that a temperature depression caused by air will disappear gradually as the air pocket heats up and is downwardly displaced until it is no longer detectable This normally takes 2 to 4 minutes When performing the test at 134 C the sterilization plateau is no longer than 3 5 minutes and the disappearance of the temperature depression has little effect on the sensitivity of the Bowie Dick test When performing the test at 121 C the sterilization plateau can range from 15 minutes to in excess of 30 minutes The rate of disappearance of the temperature depression still however takes 2 to 4 minutes thus increasing the risk of a false positive result The sensitivity of the Bowie Dick test at 121 C will be potentially reduced as a consequence of this and the final result of the test bought into question The original Bowie Dick test principle therefore cannot equally apply to short 3 5 mins and long 15 mins sterilization plateau times Browne has developed the 121 TST Test Pack to counteract this problem by producing a Bowie Dick test that has a maximum plateau of 8 3 minutes This enables the sensitivity of a 121 C Bowie Dick test to be comparable to that of a 134 C Bowie Dick test It is important that the product is used with a sterilization plateau that does not exceed 8 3 minutes This will necessitate a separate cycle which should be identical to the cycle used for sterile product production in all but the
22. itemark displayed on the TST Control Cycle Verification Emulating Indicator ISO 11140 1 1995 KM 60358 7 LON Cycle Verification Emulating Indicators TST Control Duplex Label Order code Gury 134 C 3 5 minutes 200 indicators box Conforms to EN867 1 Class D 1 ISO 11140 1 Class 6 2 Using the same technology as the TST Control Cycle Verification Indicators this duplex label can create a direct link between the patient the instruments and in pack evidence of an effective sterilization cycle Compatible with all manual traceability systems the TST Control Duplex label is ideal for use in departments clinics or surgeries that use small steam bench top sterilizers During preparation and packing information about the tray pack or pouch can be written on the label At point of use the label is retrieved and reapplied into the record card as evidence of an effective sterilization cycle p LONN Cycle Verification Emulating Indicators Em TST Control Multi part Label Order code GYD 134 C 3 5 minutes 1500 labels reel Conforms to EN867 1 Class A amp Di ISO 11140 1 Class 1 amp 6 2 Using the same technology as the TST Control Cycle Verification Indicators this multi part label creates a direct link between the patient the instruments and in pack evidence of an effective sterilization cycle Compatible with most computerised traceability
23. kes Browne TST Bowie Dick type test pack the most stringently tested and monitored test pack available worldwide There can be no greater assurance of conformance to safety and quality than the BSi Kitemark displayed on the Browne TST Bowie Dick type test pack E Pees memm ieem n a ka The Bowie Dick Test at 121 C The Bowie Dick test was originally devised to assess steam penetration in steam sterilizers working at 134 C for 3 5 minutes However a steam penetration test is equally valid for assessing steam penetration in sterilizers working at lower temperatures such as 121 C Unfortunately there is however little historical data relating to Bowie Dick tests run at 121 C research work conducted by Browne however has shown that there are potential problems in running this test at 121 C with a standard plateau period in excess of 15 minutes Air and other non condensable gases prevent steam from penetrating into packaging lumens and other porous loads When air is trapped within a load the air generally forms a bubble or pocket The temperature in this region is generally lower than that of surrounding steam environment The Bowie Dick test is historically calibrated such that when sufficient air is introduced into a sterilizer to produce a cooling effect of 2 3 C temperature depression in the centre of a standard test pack the Bowie Dick test must show a failure The Laws of Physics d
24. l be evident on the sheet US Patent no 6149863 European Patent No EP0963418 amp others Browne Plain Cotton sheets for use with this test sheet are available on order code 9053 Please refer to the relevant page of this catalogue for further details ALON Specific Use Indicators Plain Cotton Sheets Order Code QH 36 sheets box also available separately For use in small load thermometric test and traditional Bowie Dick test Bleached white cotton sheets e Size 900 mm x 1200 mm e Warp 30 6 threads per cm e Weft 27 5 threads per cm e Conform to specifications given in UK Guidance document HTM 2010 8 and EN 285 1997 7 Approximately 32 36 sheets folded to 220 mm x 300 mm would be required to produce a pack approx 250 mm in height and 7kg 10 in weight Note must be laundered before use without the use of fabric conditioning agent The Browne Sensor sheet shown is available on order code 2385 Please refer to the relevant page of this catalogue for further details ALON Specific Use Indicators Washer Disinfector Soil Test Order code GETZ 10 ready to use tests box Inefficient cleaning can put disinfection and sterilization procedures at risk A poorly functioning washer disinfector can leave behind microscopic debris that can severely compromise both the disinfection and sterilization process One of the best and easiest ways
25. n pack i control meaicator Lead free and non toxic this patented C ink technology is both safe to use and Chemical Indicators amp Accessories from Albert Browne International Ltd environmentally friendly US patent no 6149863 European patent No EP0963418 amp others z POD Multi Parameter Indicators Vapour Strip Order Code GEL 200 indicators box Conform to EN867 1 Class D 1 ISO 11140 1 Class 4 2 The Vapour Strip is intended for use by healthcare providers for the monitoring of the STERRAD Sterilization System The Vapour Strip is validated for use in STERRAD 50 and STERRAD 100S sterilizers When placed inside trays packs or pouches the Vapour Strip will confirm that sterilant has penetrated to the point of placement The indicators change from green to pink giving end users clear visual assurance of exposure to an effective STERRAD process Browne Vapour Strip indicators incorporate advanced ink technology that is both safe and environmentally friendly STERRAD is a registered trademark of Advanced Sterilization Products z O Integrating Indicators Ethylene Oxide Integrators Order code Z 100 indicators box Conform to EN867 1 Class D 1 ISO 11140 1 Class 5 2 Ethylene Oxide Integrators should be placed inside each pack The control indicator turns from red to green when adequate sterilizing conditions have
26. ndicator ESS 100 box To be used with Browne Incubator Order Code EED please specify voltage required when Load Check Holder Cea The STF Load Check indicator and holder i i a are intended for use inside each basket one eh dows abies era ica ual F or tray to verify the cleaning efficacy of a intende as a method o etecting protein surgical instrument washer disinfector residues that may have remained en mmachind surgical instruments after going through a washer disinfector process The dried test soil formula printed on bay both sides of the indicator contains two Each test o the four tests contains sources of protein lipids and 1 x test vial ae polysaccharides and is formulated to 1 x positive control vial mimic the cleaning efficacy soil tests for 1x negative control vial o surgical instruments described in 1 x Arginine vial for use in positive BS2745 9 prEN15883 49 and UK control test Guidance Document HTM2030 11 2 Stent Wane Simply place an STF Load Check indicator contains ninhydrin reagent in the holder and place the device A indicator and holder in the tray or Clean instruments are swabbed to pick up basket After running one complete cycle any non visual proteins that may be remove the STF Load Check indicator present The swab is then placed in the from the holder and examine for evidence vial of ninhydrin reagent and incubated at of residual soil 57 C 5 g g The reagent will react with amino acid Complet
27. p Accessories from Albert Browne International Ltd Strong colours High definition Easy to read A pass from the TST Control Cycle Verification Emulating Indicator proves exposure to conditions essential for sterilization to occur Unused Fail Fail Pass EN 556 2001 Sterilization of Medical Devices Requirements for medical devices to be designated sterile A sterile product is one which is free of viable micro organisms The European Pharmacopoeia Commission considers that a product may be regarded as sterile when the theoretical level of not more than one living micro organisms is present in 1x10 sterilized units of final products TST Control Cycle Verification Emulating Indicator incorporates the unique TST ink technology Lead free and non toxic this patented ink technology is both safe to use and environmentally friendly Albert Browne Ltd was the first company in the world to be able to display the BSi Kitemark on Class 6 emulating indicators for cycle verification British Standards Institution BSi not only undertook the independent testing but also examined all the necessary production control systems in place to ensure consistency of manufacture This arguably makes Browne TST Control Integrators the most stringently tested and monitored indicators available worldwide There can be no greater assurance of conformance to safety and quality than the BSi K
28. parameters of a particular process The use of a Cycle Verification Indicator will help end users detect process failure by confirming that all of the predetermined cycle parameters have occurred at point of placement in each tray pack or pouch This is demonstrated through an easy to interpret colour change ALON Biological Indicators Browne Biological Indicators have two main areas of use firstly where regulatory authorities and guidance documents require the use of a biological indicator in a specified decontamination process These usually include Ethylene Oxide Plasma and Low Temperature Steam with Formaldehyde And secondly during a machine validation process where cycle variables need to be defined and established All conform to ISO 11138 and are supplied with a certificate containing the culture collection number lot number expiry date spore population resistance data and Biological Indicator Evaluation Resistometer BIER exposure Chemical Indicators amp Accessories from Albert Browne International Ltd 3 4 Assurance BROWNE Technology j ACE Process Indicators z Mists os i j a i epe m anh Process Detector Spots Formaldehyde Order code ZED 250 spots box Ethylene oxide Order code P 1000 spots box Gamma Electron beam Order code R 1000 spots box Conform to EN 867 1 Class A 1 ISO 11140 1 Class 1 2 The self adhesive spo
29. pes of process Contents The Six Indicators p2 Process iC x p4 Specific LON COC Multi Parameter NEE Integrating MEE Cycle LONN p14 Biological om AONE CO Bowie Dick References p17 ae eee Product Index Fold Out i 2 pers oo BROWNE Formaldehyde YOR e igh ipla fo a r ea epee er Cras EE Chemical Indicators amp Accessories from Albert Browne International Ltd 1 Assurance BROWNE Technology The Six Indicator types It is important to bear in mind that each of the six categories has specific characteristics that determine where and how the indicators should be used This also determines the level depth and kind of information provided so do be sure that you choose the right type of indicator for what you want to achieve Ve ACE Process Indicators Browne Process Indicators are usually placed on the outside of the tray pack or pouch so that processed and unprocessed items can be identified at a glance They give users assurance that the tray pack or pouch has been exposed to a particular process e g steam ethylene oxide etc but cannot provide quantitative information about the process or determine how effective it has been They are sometimes referred to as exposure control or through put indicators 7 ALON Specific Use Indicators Browne specific use indicators are designed for use in two fundamental areas in specific t
30. ri TT the problem more quickly saving both as i tet i Teli se time and money G i 3 a I i eel TST Bowie Dick Daily steam penetration tests Single use test pack for small bench top Type B porous load sterilizers Daily steam penetration tests for large porous load sterilizers Eschmann Little Sister 3 Vacuum amp Order code EED SES 2000 Vacuum 134 C 137 C for up to 3 5min ode a 20 test packs box Gria exe ED Prestige Century 121 C 124 C for 8 8 3 min 22 Tee es Eine 20 test packs box Order code CREED ay A 10 test packs box see additional information across Getinge GE 224 C Conform to EN 867 4 3 Vac amp Citomat 164 V National and International Standards Ser cerle advise that vacuum assisted steam 20 test packs box Strong colours High definition sterilizers must be tested at the W amp H Lisa MB17 22 Easy to read beginning of each working day Order code EN 554 1994 lt 10 test packs box Sterilization of medical devices Mo rachana 20 Validation and routine control of Order code 2352 sterilization by moist heat AD TEBE PERKS loer Porous load autoclaves must be tested eriodically to check that the amount of Re E gas remaining in the Contorm to EN S07 sterilization chamber after the air Unused removal phase will not impair the effectiveness of steam penetration into the load to be sterilized A successful test confirms that steam penetration into a test pack is rapid and even and
31. sterilization plateau time Bowie J H Kelsey J C Thompson G R 1963 The Lancet I pp 586 1215 Chemical Indicators amp Accessories from Albert Browne International Ltd 7 8 Assurance BROWNE Technology fe N y The chemical indicator located in the 10 El capsule will show a defined colour change 4O from yellow to dark blue purple when Specific Use Indicators exposed to a specific combination of Specific Use Indicators time temperature and steam When all air has been removed from the sterilizer chamber steam will penetrate through the helix and the indicator will show a uniform colour change If air or non condensable gases are present they will Nie ie impair contact between the steam and the indicator resulting in a non uniform ra s Sa colour change distinct yellow markings m pa will be evident on the indicator _ ae j Mee The TST Helix has a limited life so after 3 wa 250 indicators have been used the one aon device must be replaced Failure to do so oo could result in failure of the device and TST Helix dangerously misleading results Sensor sheet order code EID o oaee TST Helix and 250 Indicators Conforms to EN867 5 4 National and International Standards ees ie 7 advise that vacuum assisted steam 1S0 11140 1 cl sterilizers must be tested at the EEE A beginning of each working day Sterilization of medical devices The S
32. systems for use in moist heat sterilizers Part 8 Particular requirements for self A ENIS OZS eee P contained biological indicator systems Aaa dae SEEME or VES in for use in ethylene oxide sterilizers Pari Ge Shecifiention Gar iea systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S 13 ISO 11138 1994 Sterilization of health care products Biological indicators 5 EN554 1994 Sterilization of Medical Devices Validation and Routine Control of 14 EN 556 1 2001 Sterilization by Moist Heat Sterilization of Medical Devices Requirement of medical devices to be designated STERILE Part 1 Requirements for terminally sterilized 6 EN 867 3 1997 medical devices Non biological systems for use in sterilizers Part 3 Specification for Class B indicators for use in the Bowie and Dick test 7 EN 285 1997 Sterilization Steam sterilizers Large sterilizers 8 Health Technical Memorandum HTM 2010 Sterilization Guidance Document issued by NHS Estates an Executive Agency of the Department of Health UK 9 BS 2745 1993 Specifications for Washer disinfectors for Medical purposes d 17 Assurance through Technology Box Quantity 100 indicators per box Integrating Indicators amp Accessories Description Order code Ethylene Oxide Integrators 2420 Cycle Verification Emulating Indicators amp Accessories Box Quantity Description Ord
33. to check whether instruments are being cleaned effectively is to present the cleaning equipment with a physical challenge such as the cleaning efficacy tests described in BS2745 9 prEN15883 49 and UK Guidance Document HTM2030 11 The Browne Washer Disinfector Test Soil is designed to simulate the soiling that naturally occurs during theatre use and performs in an equivalent manner to the Edinburgh soil The Browne Soil Test is supplied in powder form as individual test pots One pot One test Simply add water to the fill line replace the cap shake vigorously and apply to the test load with the brush provided Following a 30 minute drying period at room temperature the test load should be cleaned using normal procedures and then inspected for residual soil Detailed instructions for use included in each box Drying time should not exceed 2 hours The bright red colour of the Browne Test Soil allows easy identification of areas that have not been properly cleaned providing a visual analysis of equipment efficiency Non toxic contains no blood products Data on file A Browne Ltd 1998 supplied with every box Chemical Indicators amp Accessories from Albert Browne International Ltd 9 10 Assurance BROWNE Technology 5 a Specific Use Indicators Specific Use Indicators STF Load Check Ninhydrin Protein Detection Kit Order Code E ED Order code Y Load Check I
34. ts should be placed on the outside of every pack being sterilized The spots change colour after passing through the process allowing differentiation between processed and unprocessed loads Colour change Formaldehyde blue to yellow Ethylene oxide brown to green Gamma electron beam gold to dark red Note The spots do not act as a control and are not intended as a guide to the efficacy of the process e ACEH Process Indicators m Process Indicator Labels Order code Browne has a range of Process Indicator Labels Please refer to your Browne representative who can advise on the product range Conform to EN 867 1 Class A 1 ISO 11140 1 Class 1 2 The process indicator labels can be used with all types of commonly used printer and are available in a range of sizes and designs compatible with most computerised traceability systems The labels can also be handwritten Patented indicator technology US Patent no 6149863 European Patent No EP0963418 amp others Browne produces a range of labels in various sizes substrates and designs but can produce custom labels to your own specification Custom options for labels include e Simplex or duplex backing single or double backing layers for repositioning e Personalisation hospital or company logo etc e Multiple indicators e g steam and ethylene oxide e Multi part labels detachable sections for documenting different stages e
35. um will turn to yellow positive If the spores have been killed the culture medium will retain the original red colour Note Positive yellow results should be recorded and the culture tube autoclaved again prior to disposal Browne Biological Indicators for LTSF processes conform to EN866 part 5 12 Self contained biological indicators are unsuitable for use in formaldehyde sterilization processes due to the risk of sterilant residues remaining in the culture tube after sterilization These residues can release formaldehyde gas during the incubation period causing spores that survived the sterilization process to be destroyed This gives the end user a false negative growth result The use of spore strips eliminates this problem Browne LTSF Biological Indicators are inoculated with between 1x106 and 5 x 106 spores of Geobacillus stearothermophilus on a 6mm diameter paper disc These are individually packed in a sterilization pouch ready for use or can be aseptically removed and used in a Line amp Pickerill helix After exposure to the sterilization process should be placed in a recovery medium and incubated at 56 C for 48 hours for routine testing and 7 days for validation A minimum of 15ml of Tryptone Soya Broth should be used as the recovery medium Browne LTSF Biological Indicators are derived from the ATCC strain The resistance determined in relation to 10mgl 1 formaldehyde at 73 C is printed on each box of 10
36. visual confirmation of conditions achieved at point of placement The vivid colour change from yellow to blue gives clear evidence of the conditions attained thus allowing a quick and easy assessment of the success of the process Designed using advanced polymer technology to withstand conditions present during moist heat processes Des Check technology can be applied to different time and temperature combinations Please contact us to discuss your individual cycle requirements Store at or below 0 C TST Control Cycle Verification Emulating Indicator Order code To make sure you get the accuracy you need Browne have a range of Class 6 Integrators to suit any cycle profile Please refer to your Browne representative who can advise on the correct product for your sterilization cycle Conforms to EN867 1 Class Da ISO 11140 1 Class 6 2 When placed inside trays packs or pouches a TST Control Cycle Verification Emulating Indicator will confirm that good quality steam has penetrated to the point of placement Changing from yellow to dark blue purple end users have clear visual reassurance of exposure to the specific cycle parameters proven to render items sterile The TST Control Cycle Verification Emulating Indicator allows the end user to single out individual trays packs or pouches that were not exposed to sufficient sterilization conditions Chemical Indicators am
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