Infection Control

Rev. 6 | October 2018



Terragene® manufactures a very vast and complete range of chemical and biological indica- Applications tors for cleaning, disinfection and sterilization monitoring. Nevertheless, current technolo- gies, user’s guidelines, international and local regulations and market demands points to a • Healthcare reduced group of more commonly accepted and used products. Hospital, Clinics, Dental Clinics The following catalogue intends to display indispensable core products for those who are ta- • Industry king their first steps towards infection control excellence, both in Healthcare and Industry. Food, Cosmetics, Pharmaceutical, Medical Devices, Others. Page 3



With increasing demands for faster sterile instruments turnaround in healthcare facilities, ste- rilization results need to be available as soon as possible to reliably verify the sterility of the load. To fulfil these needs, Terragene® launched the Bionova® Ultra Rapid (BT224) and Super Rapid (BT222) Biological Indicators for Steam, Ethylene Oxide (BT110), Hydrogen Peroxide: Super Rapid (BT96) and Formaldehyde (BT102) sterilization processes. Their innovative tech- nology allows you to get reliable results in record time and speed up your workflow. Page 5

Bionova® PCD222-2 and PCD222-C are FDA cleared. KPCD222-2 / KPCD222-C Process Challenge Devices are designed to simulate a biological indicator (BI) placed in a large hospital pack. Bionova® PCD pre-assembled disposable test pack consists of a SCBI, a Type 5 Integrator Indicator and a self-adhesive Re- cord Card, held within a stack of porous cards that poses resistance to steam penetration. The whole ensemble is contained within a cardboard box with a self-adhesive Type 1 Process Indicator that changes color when exposed to steam. The results of the Integrator can be used to immediately release non-implant loads and for the emergency early release of implants as defined by AAMI ST79. However, AAMI recommends implant loads to be monitored by a PCD contai- ning a biological indicator as well as an integrator indicator. Page 6

IC10/20FRLCD Recording of results Bionova® IC10/20FRLCD is an automatic system for incubation and readout of Rapid, Super The device automatically records the last 208 reading results. Remote viewing on the com- Rapid and Ultra Rapid Biological Indicators and for reading Hygiene Monitoring Systems. puter through the Embedded Web Server. Touchscreen Remote access Bionova® IC10/20FRLCD has a 3,5’’LCD touchscreen. Remote display of each reading status in PC and Smartphones. Optimization of incubation times Ethernet connection Bionova® IC10/20FRLCD allows to simultaneously incubate biological indicators with diffe- Allows to connect multiple incubators to a unique traceability software regardless of where rent incubation times. Furthermore, remaining incubation time of each position is displayed they are. on the screen. Page 7 Automatic results reader Bionova® IC10/20FRLCD automatically reads the results of the incubation, displaying indica- ting icons corresponding to each BI position when the final result is obtained.

Bionova® IC10/20FR Auto-reader is FDA cleared. IC10/20FR Advantages Characteristics Allows reading and incubation of Rapid, Super Rapid, Ultra Rapid SCBIs and Hygiene Monitoring System • 12 positions for incubating Rapid, Super Rapid and Ultra Rapid Fluorescence Readout SCBIs. Optimization of incubation times • 1 position for incubating and quantifying Protein Pen (Hygiene Monitoring System). Easy to use • Special hole for external thermometer. Automatic reading and cancellation detection • 1 ampoule crusher. Automatic results reading • Dual temperature system: allows selection at 37 °C or 60 °C. Alarm system • Allows simultaneous selection of 2 different incubation programs. Printing system • USB connection for PC record keeping through Bionova® Reading and Traceability software. Storing of last 12 readings • Thermal printer for record keeping in sterilization notebooks. No maintenance required • Optional accessory: Tablet Holder. Allows the user to quickly and easily access the Bionova® Temperature calibration Traceability Software just by adapting their tablet to the holder. Bionova® Reading and Traceability software system Page 8

Easy to use Record keeping of results Allows quick, accurate and reliable detection of positive and negative BIs, providing results A thermal printer prints a ticket showing the final result of each active readout position. in short times. This allows recording of each sterilization result in a record keeping book. Automatic readout No maintenance required Bionova® MiniBio Auto-reader detects when a BI is placed in an incubation position and au- The device does not need any kind of routine maintenance. tomatically starts a readout. Temperature calibration Optimization of incubation times The device has a hole on its side to insert a thermometer, which allows temperature cali- Bionova® MiniBio allows to simultaneously incubate biological indicators with different incu- bration control. bation times. 3 positions, 3 incubation times. Compact and low-cost design Bionova® Reading and Traceability software system Bionova® MiniBio is a compact table-top auto-reader that can be placed anywhere in your USB connection for PC record keeping through Bionova Reading and Traceability software. facility thanks to its small size. Page 9

Biological indicators are the only internationally accepted devices that provide a direct measure of a sterilization cycle lethality. By using Bionova® Dual Incubator, Bionova® Conventional SCBIs produce visible results within 24 h (Steam, VH2O2) or 48 h (Ethylene Oxide, Formaldehyde and Dry Heat). Page 10

BD125X/1 BD125X/2 BD8948X / BD8948H Chemdye® Bowie & Dick Test Pack was developed to control air removal and steam Bowie & Dick Test Card penetration performance in vacuum-assisted steam sterilizers. Chemdye® Bowie & Dick Test Packs are single-use devices that consist of a lead-free chemical indicator, BD Chemdye® Bowie & Dick Test Card has been designed to monitor the effectiveness of Test Sheet, placed between porous sheets of paper, wrapped with crepe paper, with a air removal in vacuum-assisted steam sterilizers at 132 °C, 4 min and at 134 ºC, 3.5 Steam indicator label on the top of the package. Product BD125X/1 also has a Warning minutes. Chemdye® Bowie & Dick Test Card consists of a Type 2 metals free chemical Sheet which contains a circular lead free chemical indicator, thus allowing an early indicator printed on one side of the card. Chemical indicator changes from purple to detection of air removal failures before they appear on the central chemical indicator. green when processed. An heterogeneus color change, i.e the presence of purple/grey color, indicates presence of an air pocket during the sterilization cycle thus indicating sterilizer malfunction. BD8948H is a stainless steel re-usable Holder for keeping BD8948X Test Card in place for proper assessment of sterilization cycle. Page 11

This innovative and unique system consists of a highly sensitive scanner associated to Bionova® Readout and Traceability System and, both in conjunction, are capable of analysing and in- terpreting the results of Chemdye® Trazanto and Integron® Trazanto Cleaning and Sterilization Chemical Indicators. In this way, the user is able to collect the results of all the chemical indica- tors used in all the packs of the same sterilization cycle, or those used in different locations in a cleaning cycle, and to digitally store that information. Trazanto System interprets the results in a sensitive and reliable way, thus avoiding possible failures in the operator‘s visual interpretation. The recording of such results, through the usage of Bionova® software, supports and protects them, by optimizing the results’ traceability and availability, the generation and printing of reports and, therefore, the detection of failures in the performance of certain cleaning or sterilization cycles and/or equipment. Page 12

Advantages • Highly sensitive and easy-to-use scanner. • Associated Bionova Readout and Traceability Automatic System that allows the regis- tration and monitoring of results, and the generation and printing of reports. • Prevents possible failures in the operator‘s visual interpretation. • Detailed monitoring of the cycle parameters inside each sterilization pack or location inside the washing machine chamber. • Facilitates the detection of places inside the chambers of washing and/or sterilization machines where the process’ parameters are not reached, thus identifying heteroge- neities in the equipment. Chemdye® Trazanto Chemical Indicators Cleaning • CDWA4: Cleaning Indicator for Washing Efficiency tests. • CDWE: Cleaning Indicator for Washing Efficiency control in flexible endoscopes’ ho- llow internal channels. Sterilization • CD40: Type 4 Chemical Indicator for Hydrogen Peroxide sterilization processes. • CD42: Type 1 Chemical Indicator for Hydrogen Peroxide sterilization processes. • CD50: Type 4 Chemical Indicator for Formaldehyde sterilization processes. • BD125X/2: Bowie & Dick Test Pack for 3.5 minutes at 134 ºC. Integron® Trazanto Chemical Indicators Sterilization • IT26-1YS: Type 5 Chemical Indicator for Steam sterilization processes between 121ºC and 135ºC. Page 13

TYPE 1 TYPE 1 Automatic record system labels have been designed to monitor Ethylene Oxide (CD13), Steam Cintape® Self-adhesive tapes have been designed to wrap and seal sterilization pac- (CD23), Dry Heat (CD33), Plasma or Vaporized Hydrogen Peroxide (CD43) and Formaldehyde kages as well as to distinguish between items that have been exposed to sterilization (CD53) sterilization processes. These self-adhesive labels are usually placed out of the plate, processes from those that have not. stuck to packages or pouches, allowing differentiation between processed and unprocessed items. Their double-adhesive technology allows easy label removal from the sterilization pac- kage for data documentation. CG3 Chemdye® CG3 is a Three-line Automatic Labeler that allows a quick and easy labelling of steri- lization packages through the use of special documentation labels. Chemdye® CG3 labeler has three printing lines of twelve alphanumeric digits per line. Page 14

Single and double strips TYPE 4 Chemdye® Type 4 internal control strips are multi-variable indicators that rapidly show if criti- cal parameters of the sterilization process have been reached, ensuring appropriate penetra- tion of the sterilizing agent inside the packages.These chemical indicators offer a distinct color change when exposed to the stated values (SVs) of the critical process variables. Page 15

IT26-1YS Unique point integrator - TYPE 5 It was developed for verification of Steam sterilization cycles between 121 °C and 135 °C. These products ensure an adequate control of the effectiveness of sterilization processes (temperature, time, steam quality). IT26-C IT12 Moving front integrators - TYPE 5 EO Two level integrator - TYPE 5 It was developed for monitoring Steam sterilization processes between 118 ºC and 138 ºC It was developed to control Ethylene Oxide sterilization processes. It is a two-level indicator: and to ensure an adequate control of the effectiveness of sterilization processes by monito- Level 1 is the exposure level, which indicates exposure to Ethylene Oxide, while Level 2 is the ring all critical parameters of steam sterilization (temperature, time, steam quality). Chemi- integration level. This second level consists of a purple/brown ink dot that turns to green as cal pellet melts and migrates as a dark bar along the paper wick. Migration occurs through a it integrates all critical parameters of the sterilization process (time, temperature, humidity zone marked as ACCEPT or REJECT, thus indicating whether sterilization conditions were met and Ethylene Oxide concentration). This indicator mimics the death curve of a theoretical or not. The “ACCEPT” result is reached when a theoretical spore population reaches its kill Bacillus atrophaeus spore population. time, indicating integration condition has been reached. Page 16

IT31 TYPE 6 Designed to react to Dry Heat sterilization processes at 160 ºC for 40 minutes. Its blue indica- ting ink has been developed to turn to brown when the process reaches the stated values of the critical process variables for which it has been designed. IT27-3YS TYPE 6 Designed for monitoring Steam sterilization processes at 134 °C for 3 minutes. They fulfil the requirements for Type 6 indicators monitoring all the critical parameters of the sterilization process at their position in the chamber, and ensuring an adequate control of the efficacy of the sterilization processes (temperature, time, steam quality). Page 17

Control of cleaning and washing processes of medical instruments and materials is highly CDWU important since its outcome affects the success of subsequent disinfection and/or steriliza- tion processes. Chemdye® CDWU indicator consists of a transparent vial, with a blue-colored reactive so- lution and glass beads immersed in it. The formulation of the solution contained in the vial Chemdye® Splat allows the monitoring of cavitation capacity of the ultrasonic washer. When cavitation func- tions properly, vibration of the glass pearls triggers a color change in the solution, from blue Chemdye® Splat indicators consists of a synthetic support, which is stable at disinfection to yellow, through a range of green color intermediates. temperatures. Each indicator contains a mixture of specially combined colored organic com- The CDWU indicator can be used for routine monitoring of ultrasonic cleaning washing ma- ponents. Splat indicators formulation allows detection of all factors that affect the cleaning/ chines with different ultrasonic washing configurations. It should be noticed that the CDWU washing process outcome. Splat indicators can be used for routine monitoring of cleaning/ indicator was developed to monitor the cavitation performance of the ultrasonic washing washing processes in automatic machines with different washing and thermodisinfection machine with an empty tank, that is, without any load. configurations. The CDWAH holder can be fixed on the tray, which allows reproducible location of the clea- ning indicator in the washer-disinfector. When a CDWA cleaning indicator is placed within the holder, half of the test soil is covered, thus simulating the joint of a surgical instrument, with water stream hitting it indirectly. The other half of the test soil is covered by a mesh, thus posing a difficulty for water stream to reach it, imitating shadowed or occluded surfaces. Page 18

After cleaning, surgical instruments must be disinfected to ensure safe subsequent handling and processing. Thermal disinfection with moist heat is the most common method for disin- fection of medical devices in the hospital setting. Disinfection effects can be defined by the A0 value, a physical parameter specified in ISO 15883-1, which denotes the inactivation of microorganisms. A particular A0 value can be achieved with the most diverse temperature/ time combinations. For processing surgical instruments, an A0 value of 600 is specified in ISO 15883-2, corresponding to a hold time of 1 minute at 90 °C, ensuring lethality of bacte- ria, mycobacteria, fungi and heat-sensitive viruses. If efficacy is also to be ensured against heat-resistant viruses, e.g. hepatitis B, many authorities in the field of disinfection, like the Robert Koch Institute, recommend an A0 value of 3000, corresponding to a temperature of 90 °C with a hold time of 5 min. A higher safety approach from this institute comprises a cycle at 93ºC, 10 minutes, a program known as the“BGA/RKI”or epidemic program. IT27W-5 / IT27W-10 Integron® Indicators have been designed to react in moist heat disinfection processes in washer-disinfectors, providing an accurate, convenient method of routine control, and assu- ring disinfection efficiency. The green indicating ink was developed to turn to purple when temperature and time conditions are met. Page 19

Chemdye® Lumenia kits have been designed to control the flexible endoscope washing process Advantages efficacy in Automatic Endoscope Reprocessors (AERs), both for internal and external cleaning check. The unique capsule configuration allows simultaneous corroboration of internal chan- • Allows direct and distinct determination of external and internal successful cleaning efficacy nels and external parts of the endoscope during automatic reprocessing. This capsule is desig- of flexible endoscopes when using AERs. ned for housing (internal) and holding in place (external) the Chemdye® Lumenia cleaning • The indicator cleaning ink formulation allows monitoring and integration of all important indicator strip. This strip has been especially formulated to monitor all essential parameters in parameters of the process. successful endoscope reprocessing. Complete removal of the Lumenia cleaning indicator ink • Lumenia cleaning indicator use grants very simple interpretation of results, avoiding the confirms an adequate internal and external cleaning efficacy of the endoscope. If indicator ink need of special skills or training of operators. remains after the washing cycle, the endoscope cannot be considered successfully cleaned. •When usingTrazanto System, results can be easily registered and traced, thanks to the special The Lumenia KCCDER122 kit possesses three parallel channels (a 1 mm inner diameter channel design of the Lumenia cleaning indicator. and two 2 mm inner diameter channels), thereby simulating the regular channel configuration •Very resistant and durable devices, thanks to the high quality material used in their confection. of most flexible endoscopes. On the other hand, Lumenia KCCDER1 and KCCDER2 kits consist of only one (1) channel, with 1 or 2 mm of internal diameter respectively. By using these three options, the user can combine and monitor any available AER configuration in the market. Page 20

The first step in properly cleaning surgical instruments is to rinse off all blood, bodily fluids and tissue immediately after use. If cleaning is not carried out adequately, it may render the disinfection stage ineffective, causing patients to be exposed to body fluids and tissue con- taminants from prior patients, which can result in the transmission of pathogens and affect large numbers of people. KPRO2-E250 Chemdye® KPRO2-E250 Hygiene System is designed to check cleanliness of surgical equip- ment by detecting protein residues left behind following improper cleaning. The system has a high absorption swab, allowing the collection of samples from different surfaces with the same efficacy. The system is compatible with cleaning verification of endoscopes and other reusable instruments with hard to reach internal channels or cannulated instruments. Page 21

Page 22 PRO1 MICRO Terragene® has developed the Chemdye® PRO1 MICRO Hygiene Monitoring System which not only detects but also quantifies proteins, allergens and reducing agents on the surfaces of instru- ments, after the cleaning and disinfection process. The system consists of a pen that has a high absorption swab and two separate reactive solutions contained within the same device. After taking the sample from the selected surface, the swab is returned to the pen, activated and the result is then obtained at 15 minutes of incubation at 60 ºC (using Bionova® IC10/20FR and IC10/20FRLCD) or 10 minutes at 60 °C (in Bionova® MiniPro Auto-Reader). By visual color change of the reactive solution, it is possible to determine whether reprocessing and/or retesting of the tested surface is necessary. Using the Bionova® IC10/20FR, IC10/20FRLCD or MiniPro Auto-readers with automatic reading system, the Chemdye® PRO1 MICRO system can be incubated and obtain a quantitative result with a sensitivity of 0.3 μg. Advantages • Easy to use and interpret due to accurate color change, originated by a colorimetric reaction. The more soil detected, the quicker and darker the color changes. • Low cost and easy to use. • High sensitivity. • Rapid test results in 15 minutes or less. • Provides qualitative data. Comparison of the final color against a color pattern included within the device allows estimation of cleanliness. • It does not require handling dangerous chemical substances in specialized laboratories. • Quick results that allow taking immediate remedial action and avoiding healthcare-acquired infections. • Manufactured under ISO 15883-1 standard and follow recommendations set in the HTM 01-05 and HTM 01-01 guidelines. • Our reading devices provide quantitative data. • Traceability Software results according to the HTM 01-01 guidelines.

Quantitative analysis of Hygiene Monitoring Systems No maintenance required Bionova® MiniPro is an advantageous and very sensitive tool for incubation of hygiene moni- The device does not need any kind of routine maintenance. toring systems since it offers the user the unique benefit of performing a quantitative analy- sis of small quantities of protein and allergens, thus providing an exclusive and convenient Temperature calibration way to keep results recording and traceability of every surface checked for contaminants. This exclusive feature makes Bionova® MiniPro an innovative device to keep objective track of The device has a hole on its side to insert a thermometer, which allows temperature cali- surface cleaning process monitoring unparalleled on the current market. bration control. Optimization of incubation times Compact and economic design Bionova® MiniPro has 3 incubation positions, thus allowing the incubation of 3 Protein Detec- Bionova® MiniPro is a compact table-top incubator that can be placed anywhere in your tion System Pens at the same time. facility thanks to its small size. Record keeping of results Page 23 A thermal printer prints a ticket showing the final result of each active readout position. This allows to register each result in a record keeping book. Bionova® Reading and Traceability software system USB connection for PC record keeping through Bionova Reading and Traceability software.



CD210 / CD220 TYPE 4 Chemdye® CD210 and CD220 Chemical tubes have been developed to monitor Steam steri- lization of liquids. These are easy-to-use multivariable indicators, consisting of borosilicate glass tubes of 40 x 7 mm, sealed at both ends. The tube contains 0,25 ml of a thermosensi- tive red liquid that turns to green when the stated values of the critical process variables of the sterilization process have been reached. Advantages Code Description Conditions Sterilization CD210 Black spot 15 min. 121 ºC / 10 min. 126 °C Steam Readability. Color change from red to green provides an easy interpretation CD220 Yellow spot 3-3.5 min. 134 ºC Steam of the results. Stability. A permanent color change allows an immediate evaluation of the Performance sterilization cycle. Reliability. It meets the quality standards from Type 4 multivariable indicators Chemdye® Chemical Tubes can be placed within the product to be sterilized. After exposure according to ISO 11140-1:2009. to the specific conditions, the liquid shows a permanent color change indicating that the Flexibility. Different times and temperatures are available to control standard parameters of the sterilization have been met. sterilization cycles. Traceability. Batch number and sterilization date are printed on each box. Initial color Rejected Final color Easeofuse: Allows monitoring sterilization of liquids in ampoules and containers. Sense of color change Page 25

Bionova® Spore Strips consist of an envelope, permeable to the sterilizing agent, contai- BT21 / BT22 / BT23 / BT24 ning a paper strip inoculated with a spore population. After exposure to the sterilization process, strips are aseptically transferred to the culture Bionova® spores ampoules are self-contained biological indicators for monitoring industrial media tube and incubated in the Bionova® Dual Incubator according to the specific con- steam sterilization processes of liquids. Consists of different volumes of culture medium ino- ditions. If sterilization has failed, culture medium will turn to yellow. Conversely, if the culated with a specific spores population: Geobacillus stearothermophilus ATCC 7953 (BT21, sterilization process has been successful, the culture medium will remain its original color. BT22 and BT23) and Bacillus subtilis DSM 5230 ATCC 35021 (BT24) within an hermetically sealed type I borosilicate glass. The culture medium is specially formulated to turn to yellow when spores grow. The non-pathogenic organism is killed after an efficient steam steriliza- tion cycle. Bionova® spores ampoules provide visual confirmation of sterilization within 48 hs of incubation at 60 °C (BT21, BT22, BT23) or 37 °C (BT24). Advantages • Easy to use and read. • Does not require activation. • Incubation within the same recipient. • Evidence of growth with direct visual confirmation. • Allows sterilization of liquids. • Available in packages refrigerated at 4 - 8 ºC, includes negative controls. Page 26 BT21/BT22/BT23 121-134 ºC Steam BT24 110-121 °C Steam