We are improving; we are thinking in the future.
Sterilization Controls Division Catรกlogo - Catalogue 2012-2013
Chemink Chemdye
Cintape Chemdye
Integron Cintape
Company TerrageneŽ, whose R&D production plant is located in Rosario (Argentina), is a brand-new leading company devoted to manufacturing high complexity products for the healthcare, the environment and food production areas. The company mainly deals with the research and development of products aimed at improving people´s lifestyles around the world. The company has committed itself to innovating in the healthcare and industry areas well as cooperating in the care and respect for nature.
Integron
Sterilization Controls Division Biological Indicators - Self-contained Systems - Spore Strips - Mini Discs and Mini Spore Strips - Spores Suspensions - Self-contained Spore Ampoules - Culture Mediums
Chemical Indicators Healthcare- Sterilization Division Nowadays there is a worldwide problem which has become even more serious in the last 20 years: the new strains of microorganisms resistant to drugs and antibiotics are spreading more and more each day. The pharmaceutical and biotechnological industries strive every day to discover and produce new antibiotics which will hit the target on microorganisms, and efficiently affect their reproduction or kill them, at best. However, since human beings are in constant evolution and mutual interaction, the development of new antimicrobial agents becomes more and more difficult and expensive every day. Furthermore, specialist are concerned about the fact that antibiotics which are nowadays effectively used in hospitals might soon lose their effect due to genetic mutations and rearrangements, thus neutralizing the action of drug. At present, many antibioticresistant mechanisms are supposed to exist in nature. Due to genetic transmission among microorganisms (horizontal transmission), these systems get into pathogenic microbial species thus avoiding the antibiotics effect. When this happens, the natural selection will maintain, increase and distribute the population of those strains which became resistant.
- Process Indicators (Strips, Stickers and Paper Tapes) - Multi-parameter Indicators - Integrators and Emulators - Bowie-Dick Tests Inks for Sterilization Processes - Flexography Inks - Serigraphy Inks - Additives Accesories - Dual Incubators - Readers Dual Incubators - Humidity System for EO processes
We are improving; we are thinking in the future.
2007-2008
2014-2015
2010-2011
2012-2013
2016-2017
2018-2019
Biological Indicators
Self-Contained Biological Indicators (SCBI) ®
Bionova Self Contained Biological Indicators were developed to control Steam, Dry Heat, Ethylene Oxide, Moist Heat, Peroxide Hydrogen Plasma and Formaldeheyde sterilization processes. Biological Indicators contain bacterial spores on a filter-paper carrier packaged within a special plastic tube. Inside the tube, is a sealed-glass ampoule of specially-formulated culture medium containing a color indicator which turns dramatically to yellow when spores grow. Bionova ® Biological Indicators produce visible results within 24 hours (Steam, Plasma, Formaldehyde) or 48 hours (Ethylene Oxide, Moist Heat, Dry Heat). ®
Bionova Biological Indicators are certified for species, population, purity, resistance (D value, Z value and survival/ kill data). ® Bionova Biological Indicators are developed and manufactured under ISO 9001:2000 and ISO 13485:2003 certified systems. The quality parameters are determined at time of manufacture according to ISO 11138 (Parts 1, 2, 3, 4 and 5) standards.
Organism
Code
Process
B. atrophaeus G. stearothermophilus B. atrophaeus B. atrophaeus G. stearothermophilus G. stearothermophilus
BT10 BT20 BT30 BT80 BT91 BT100
Ethylene Oxide Steam Dry Heat Moist Heat Peroxide Hydrogen Plasma Formaldehyde
Packaging 30 or 100 pcs. 30 or 100 pcs. 30 pcs 30 or 100 pcs 100 pcs 100pcs
Shelf Life: 24 months Population: Requested by the customer
Bacillus atrophaeus ATCC 9372 Geobacillus stearothermophilus ATCC 7953
F1 Rapid Readout Colorimetric Biological Indicators ®
Bionova F1 Rapid Readout Colorimetric self contained biological indicators system were developed to control steam, VH2O2 plasma and Formaldehyde sterilization processes. The Biological Indicators contain spores bacterium soaked in a carrier placed inside the plastic tube. The system contains a tube with a conic base and a special filter that keeps the glass at the top of the tube. Inside the tube there is a small glass ampoule with culture medium containing a color indicator specially developed for the bacterial growth. An easy readout can be carried out using the reference color table under the white light source. The table permits the easy detection of positive biological indicators. The use of the reference color table allows a final lecture within the first 8 hours of incubation with more 97% sensibility. The system does not require longer incubation time for the reconfirmation of the result. ® Bionova F1 Rapid Readout Colorimetric system is the only product in the world that permits the easy visual and cheap readout.
Code
Organism
BT90 BT200 BT101
G. stearothermophilus G. stearothermophilus G. stearothermophilus
Process Plasma Steam Formaldehyde
Packaging 100 pcs 100 pcs 100 pcs
1
Biological Indicators
Rapid Readout Biological Indicators ®
Bionova Rapid Readout self contained Biological Indicators were developed to control Steam and Ethylene Oxide sterilization processes. The Biological Indicators contain bacterium spores soaked in a filter paper placed inside a plastic tube. Inside the tube there is a glass ampoule with culture medium containing a color indicator specially developed for the bacterial growth. The innovative characteristic of this system is the rapid readout that can be obtained thanks to the culture medium formulation that permits a rapid detection of a fluorescent product, generated by the activity of the enzyme glucosidase that catalyzes the modification of a non fluorescent substrate. This enzyme is synthesized during the Bacillus atrophaeus y Geobacillus stearothermophilus spore germination. The fluorescent product generated by this enzyme can be detected with high ® sensibility in the reader/incubator Bionova IC10/20F or in any fluorescent reader which complies with the descripted specifications for each product. The coloration of the culture medium allows reconfirmation of the result obtained with the reader at 24 or 48 hours respectively.
Code
Organism
BT110 BT220
Process
B. atrophaeus G. stearothermophilus
Ethylene oxide Steam
Biological Indicators in Ampoules ®
Bionova Spore Ampoules are self-contained Biological Indicators for monitoring industrial Steam sterilization of liquids or washer sterilizers. Spore Ampoules are made of an hermetically sealed type I borosilicate glass, containing a specific population of Geobacillus stearothermophilus or Bacillus subtilis spores and a specially formulated synthetic culture medium that turns dramatically to yellow when spores grow. ® Bionova Spore Ampoules provide easy visual confirmation of sterilization within 48 hours incubation. The Ampoules are available in packages, refrigerated at 4 - 8 ºC. Ampoule Dimensions: (BT21 diameter 7 mm x 40 mm, BT22 diameter 7 mm x 25 mm, BT23 diameter 11 mm x 58 mm, BT24 diameter 7 mm x 40 mm, BT25 diameter 7 mm x 40 mm ) Shelf Life: 24 months. Population: Requested by the customer.
Code
Lengh
Population
BT21-4 BT21-5 BT21-6
40 mm 40 mm 40 mm
4
10 5 10 6 10
200 + 20 negatives 200 + 20 negatives 200 + 20 negatives
BT22-4 BT22-5 BT22-6
25 mm 25 mm 25 mm
10 5 10 6 10
4
250 + 25 negatives 250 + 25 negatives 250 + 25 negatives
BT23-4 BT23-5 BT23-6
58 mm 58 mm 58 mm
10 5 10 6 10
4
50 + 5 negatives 50 + 5 negatives 50 + 5 negatives
BT24-4 BT24-5 BT24-6
40 mm 40 mm 40 mm
10 5 10 6 10
4
200 + 20 negatives 200 + 20 negatives 200 + 20 negatives
BT25-4
40 mm
10
4
200 + 20 negatives
10
6
BT25-6
2
40 mm
5
Packaging
200 + 20 negatives
Packaging 50 pcs 50 pcs
Biological Indicators
Spore Strips ®
Bionova Spore Strips were developed to control Steam, Dry Heat, Ethylene Oxide, Hydrogen Peroxide Plasma, Gamma radiation and Formaldehyde sterilization processes. ® Bionova Spore Strips are conventional paper strip biological indicator that contain bacterial spores on a filter paper carrier sealed within a special envelope. The strips could be fit into small areas of a device, where a standard self-contained Biological Indicator can not be used, such as within a syringe, inside a tubing, inside a product or in a product package. Upon removal from the sterilizer, the inoculated package is sent to the microbiology laboratory for the spore survival evaluation. The strip must be aseptically ® cultured in Bionova MC1030,MC20, MC1020 or MC70 mediums, and incubated at the appropriate temperature. Strips are available packaged in glassine envelopes or in bulks.
Strip Envelope Dimesions: (70 mm x 25 mm) Carrier Dimensions: (25 mm x 5 mm) Growth Medium: MC1030, MC20, MC1020, MC70
Processes
Codes BT40 BT50 BT60 BT70 BT92 BT93
Organism: Bacillus atrophaeus ATCC 9372 Geobacillus stearothermophilus ATCC 7953 Bacillus pumilus ATCC 27142 Population: Requested by the customer Packing: 100 units or in bulks Shelf Life: 24 months
Ethylene Oxide and Dry Heat Sterilization Processes Formaldheyde and Steam Sterilization Processes Steam, Ethylene Oxide and Dry Heat Sterilization Processes Gamma Radiation Sterilization Processes ® Hydrogen Peroxide Plasma Sterilization Processes ( Tyvek paper strip) Hydrogen Peroxide Plasma Sterilization Processes ( Stainless steel coupon strip)
Mini spore Strips and Discs ®
Bionova Mini spore Strips and Discs were developed to control Steam, Dry Heat, Ethylene Oxide, Hydrogen Peroxide Plasma, Gamma radiation and Formaldehyde sterilization processes. The strips or discs could be fit into small areas of a device, where a standard spore strip can not be used, such as a syringe or inside a tubing. Mini spore strips and discs are available in glassine envelopes packages or in bulks. Bionova® mini Spore Strips and discs allow to evaluate the efficiency of a sterilization cycle for specific medical products or devices used in the food or pharma production.
Strip Dimensions: (2mm x 10 mm) Shelf life: 24 months Population: Requested by the customer Packing: 100 pcs.
Discs Codes
Strips Codes
BTD40 BTD50 BTD60
BTM40/ BTM40G BTM50/ BTM50G BTM60/ BTM60G
BTD70 BTD90
BTM70/ BTM70G BTM90/ BTM90G
Discs Dimensions: (1/3”, 1/4”, 1/8”) Growth Medium: MC1030, MC20, MC1020, MC70.
Processes Ethylene Oxide and Dry Heat Sterilization Processes Formaldehyde and Steam Sterilization Processes Steam, Ethylene Oxide and Dry Heat Sterilization Processes Gamma ionization Hydrogen Peroxide Plasma Sterilization Processes
Organism: Bacillus atrophaeus ATCC 9372 Geobacillus stearothermophilus ATCC 7953 Bacillus pumilus ATCC 27142
Note: The mini strips and discs are available in bulks or glassine envelopes (G) 3
Biological Indicators
Syntetic Culture Medium for Bacterial Growth ®
Bionova Culture Mediums were developed for the germination and growth of bacterial spores of Geobacillus stearothermophilus, Bacillus atrophaeus, Bacillus pumilus and Bacillus subtilis. ® Bionova Culture Medium can be used to test the viability of spores placed in carriers of biological indicators for sterilization, as spore ® strips, mini spore strips, spore discs or other Bionova spore carrier. Culture Mediums are specially made to provide an easy visual ® confirmation of bacterial growth within 24 or 48 hours. Bionova culture medium changes dramatically from purple, red or blue to yellow when spores grow. Shelf Life: 24 months
Codes
Organism growth
MC1030/ 01/ 80/ 150/ 500 MC20/ 01/ 80/ 150/ 500 MC1020/ 01/ 80/ 150/ 500 MC70/ 01/ 80/ 150/ 500
B. antrophaeus G. stearothermophilus G. stearothermophilus or B. atrophaeus B. pumilus
Color Blue to Yellow Purple to Yellow Red to Yellow Red to Yellow
Volumen 1ml/ 80ml/150ml/ 500ml 1ml/ 80ml/150ml/ 500ml 1ml/ 80ml/150ml/ 500ml 1ml/ 80ml/150ml/ 500ml
Incubation Time 48 hrs. 24 hrs. 24 hrs. 48 hrs.
Spore Suspensions ®
Bionova Spore Suspensions are calibrated suspensions of bacterial spores appropriate for direct inoculation of products or preparing custom Biological Indicators for monitoring Steam, Ethylene Oxide, Dry Heat, Hydrogen Peroxide, Formaldehyde and other industrial sterilization processes. After a sterilization cycle is complete, the inoculated product should be ® tested using the aproppiate Bionova Culture Medium. ® Bionova Spore Suspensions are standardized on the basis of number spores per 0.1 ml suspension.
Codes
Organism
BT10S BT20S BT24S BT70S
B. atrophaeus G. stearothermophilus B. subtillis B. pumilus
Culture Medium MC1020/ MC1030 MC20/ MC1020 MC1020 MC70
Glass bottle Dimensions: 18 mm of diameter and 63 mm of length Shelf life: 24 months Population: Requested by the customer
Stainless Steel Coupons ®
The Bionova Spore Coupons were developed to control Peroxide Hydrogen (VH2O2) sterilization processes. Bionova ® Spore Coupons are stainless steel coupons that contained Geobacillus stearothermophilus ATCC 7953. Upon removal from the sterilizer, the coupon must be aseptically cultured in ® Bionova MC20 or MC1020 growth medium tube, or to any other appropriate growth medium. ® Bionova Coupons are available packaged in bulks.
Coupon Dimensions: (34 mm x 7 mm x 0.8 mm) Growth Medium: MC20, MC1020 Population: Requested by the customer Packing: 100 units per box Shelf Life: 12 months Code: BTC90-1 4
Biological Indicators / Process challenge devices
Incubators for Biological Indicators ®
Bionova IC10/20 Incubator has been developed for the incubation of Self-contained Biological Indicators, but can be used to incubator others products too. Bionova® IC10/20F Incubator has been developed for the incubation of Rapid Readout Self-contained Biological Indicators BT110 and BT220. The Bionova® IC10/20F incubator has an automatic readout system and a printer to record the results. ®
Bionova IC10/20 and IC10/20F incubators are pre-set at 37 or 60 ± 2 ºC. This temperature cannot be modified. The incubation temperature can be selected using the switch button located at the base of the incubator. During the heating, the red light will be intermittent until reaching the selected temperature. ® The Bionova IC10/20 and IC10/20F incubators work at room temperature of 1535 ºC, a relative humidity of 35-85%, and a voltage of 110 and 220 volts. The incubators are manufactured with high quality materials and are easy to use.
Codes
Temperatures
Volts
IC10/20
37º C and 60 ºC
110 v and 220 v
IC10/20F
37º C and 60 ºC
110 v and 220 v
Steam Test Pack (PCD) ®
Bionova PCD20-1 and PCD220-1 Process Challenge Devices were designed to detect inadequate air removal and steam penetration in prevacuum and gravity steam autoclaves. ®
Bionova Process Challenge Devices are composed of a Class 1 Indicator, Class 5 Indicator Integrator and a Self-contained Biological Indicator. The circular label with Class 1 indicator is outside the product, while the Class 5 Indicator Integrator and the Self-contained Biological Indicator are into the Challenge Device.
Class 1 Process Indicator Initial color: purple Final color: green
External Label
Class 5 Indicator Integrator Initial color: purple Final color: green
Internal Label
®
Bionova PCD20-1 contained a BT20 Biological Indicator. ® Bionova PCD220-1 contained a BT220 Biological Indicator.
5
Chemdye
Process challenge devices
Helix Process Challenge Device (Helix-PCD) ®
Chemdye Helix-PCD has been designed to evaluate the penetration characteristics of the sterilizing agent (Ethylene oxide, Formaldehyde, Hydrogen peroxide/ Plasma or Steam). It allows evaluating the air removal and the sterilizing agent penetration into the cavities, devices and hollow instruments. Air and other not condensable gases (NCG) need to be removed from the sterilization camera before the sterilizing agent gets in touch with the hollow devices to be sterilized. The practical experience has evidenced that the presence of gases or air in the hollow devices to be sterilized, affects negatively the result after the sterilization process. ®
Helix-PCD Chemdye System consists in a stainless steel capsule of great resistance and durability, to hold a chemical indicator designed for this system, or a biological indicator in disk or strips format. The stainless steel capsule has a screw cap; thought the one the indicator can be introduced, this indicator has to be subjected to a pin in the cap. The capsule is connected to a high resistance plastic tube and 2 mm internal diameter. The plastic tube is placed in a circular way and it should not be released for the advice use. The tube and capsule union is hold by a special rubber connector. Small sterilizers not operating with fractionated vacuum are unable to ® remove air from longer hollow devices. Therefore, TERRAGENE offers the Helix-PCD Systems for small sterilizers. The traditional Helix- PCD systems should be used for all other sterilizers.
Inner diameter (mm)
Code
Sterilization Process
Processes
For sterilizers with fractionated vacuum
CDPCD2X15 CDPCD2X30 CDPCD2X45
2 2 2
1.5 3.0 4.5
Steam and EO Steam and EO Steam and EO
For small sterilizers with gravity displacement or overpressure cycles
CDPCD2X025 CDPCD2X050 CDPCD2X075 CDPCD2X10 CDPCD2X15
2 2 2 2 2
0.25 0.50 0.75 1.0 1.5
Steam, EO, Form and Plasma Steam, EO, Form and Plasma Steam, EO, Form and Plasma Steam, EO, Form and Plasma Steam, EO, Form and Plasma
Chemical indicators designed for Helix-PCD System are the PCD-A: STEAM (Class 2 chemical indicator for Bowie-Dick simulation test)
Code PCD-A-3.5 PCD-A-5.3 PCD-A-7.0 PCD-A-9.0 PCD-A-18
Exposure Conditions 3.5 min. 134 5.3 min. 134 7.0 min. 134 9.0 min. 134 18 min. 134
ºC ºC ºC ºC ºC
yellow to black blue to black green to black pink to black green to reed
FORM-EO-PLASMA
Code
Exposure conditions
PCD-A-F1 PCD-A-E1 PCD-A-P1
Formaldehyde processes Ethylene Oxide processes Plasma processes
purple to green light blue to green purple to green
If the 4 bars change to the final color, the result is successful, so the sterilizer is working correctly. If one bar is different to the final color, it shows the presence of residual air in the sterilizer, therefore an equipment malfunction. ®
The Helix-PCD Chemdye Device and the Indicators are manufactured, calibrated and designed according to EN 285, EN ISO 11140-1, EN ISO 11140-4 and EN ISO 11140-5 standards. 6
Tube length (m)
Chemicals Indicators
Chemdye Container Seals ®
Chemdye Container Seals were developed to control Steam sterilization process. The product is used to seal instrument containers to prevent accidental use of the contents if the container has been tampered with or opened by mistake or has not been sterilized. ®
Chemdye Container Seals are composed of a self-adhesive label with Class 1 indicator and a pin. The pin is inserted into the Container Seal construction and the end of the pin is adhered between the folded label. The label area provides the space for production and expiry date, batch number, initials of the person responsible releasing the load and the container content. Label Dimension: 7.0 cm x 2.9 cm Pin Dimension: 7.5 cm of length
Chemical Tubes for Sterilization Control Chemdye ® Chemical Tubes contain a heat sensitive red liquid which changes color from red to green at various times and temperatures that are integrated by the device. The chemical tubes are calibrated to respond to specific temperature and time parameters during a Steam or Dry Heat sterilization cycle. ®
Chemdye Chemical Tubes have a permanent colour change when the proper parameters are achieved at the location of each control tube. A color guide in the instruction provides an instant visual check of the results.
Code
Description
CD210 CD220 CD230 CD240 CD250
Type 1: Black Spot Type 2: Yellow Spot Type 3: Green Spot Type 4: Blue Spot Type 5: White Spot
Sterilization Steam Steam Dry Heat Dry Heat Dry Heat
Initial Colour
A color guide in the instruction provides an instant visual check of the results. Since the chemical tubes consist of sealed vials containing heat-sensitive solution, chemicals from the indicator do not normally come into contact with adjacent items during the cycle.
Rejected
Final Colour
Sense of colour change
®
Chemdye Chemical Tubes corresponds to Class 4 Indicators according to EN ISO11140-1 standard.
7
Integrators and Emulators
Integron
Three Phased Sequential Indicators. ®
Integron IT26 Integrator and IT27 Emulator Indicators, were developed to control steam sterilization processes . These products ® are manufactured with Chemink high technology inks for sterilization processes. Integron® IT26 and IT27 are bi-laminated strips of 60 x 25 mm. The inks change sequentially according to the exposure time and temperature.
®
1
IT26
STEAM
INTEGRATOR ISO 111 4 0 -1 Cl a s s 5
EN 8 6 7 -1 Cl a s s D
2 1
3
3
1
SAFE
®
2
3
2
1
UNSAFE
1
3 .5 m i n -1 3 4 ºC / 1 5 m i n -1 2 1 ºC
2
LO T: I T 2 6 0 4 .2 0 0 9 EXP: 0 4 .2 0 1 4
ISO 111 4 0 -1 Cl a s s 5
2
3
EN 8 6 7 -1 Cl a s s D
2 1 ®
OPTIMUM
STEAM
IT26
INTEGRATOR
3
3
2
1
UNSAFE
1
3 .5 m i n -1 3 4 ºC / 1 5 m i n -1 2 1 ºC
2
LO T: I T 2 6 0 4 .2 0 0 9 EXP: 0 4 .2 0 1 4
3
1
SAFE
2
3
®
OPTIMUM
®
®
3 ISO 111 4 0 -1 Cl a s s 5
EN 8 6 7 -1 Cl a s s D
2 1
3
3
1
SAFE
12 10
Time to go to black (minutes)
3
1
SAFE
2
3
®
OPTIMUM
.3
PO S. 2
Pe r fo
rm an
POS
115
ºC
®
STEAM
EMULATOR EN 8 6 7 -1 Cl a s s D
7 m i n -1 3 4 ºC / 2 0 m i n -1 2 1 ºC
2
120 ºC
3
1
IT27
ce
( *)
.1
125 ºC
3
SAFE
1
LO T: I T 2 7 0 4 .2 0 0 9 EXP: 0 4 .2 0 1 4
135 ºC
EN 8 6 7 -1 Cl a s s D
2 1 ®
STEAM
EMULATOR ISO 111 4 0 -1 Cl a s s 6
2
3
®
2
3
OPTIMUM
130 ºC
Temperature
1
2
®
130 ºC
135 ºC
STEAM
EMULATOR ISO 111 4 0 -1 EN 8 6 7 -1 Cl a s s D Cl a s s 6
2
8
St rip s
(* ) Spore strips performace corresponds to the Killing Time/Temperature
3
PO S. 1
125 ºC
3
2
7 m i n -1 3 4 ºC / 2 0 m i n -1 2 1 ºC
2 3
UNSAFE
Temperature
1
1
2
7 m i n -1 3 4 ºC / 2 0 m i n -1 2 1 ºC
2 3
UNSAFE
IT27 1
2
1
3
1
SAFE
LO T: I T 2 7 0 4 .2 0 0 9 EXP: 0 4 .2 0 1 4
3 2
3
®
OPTIMUM
S .3
8
120 ºC
PO S
8
0
1
115 ºC
Sp or e
4
ISO 111 4 0 -1 Cl a s s 6
10
0
3
LO T: I T 2 6 0 4 .2 0 0 9 EXP: 0 4 .2 0 1 4
OVER KILL PERIOD
14
2
4
IT26
3 .5 m i n -1 3 4 ºC / 1 5 m i n -1 2 1 ºC
2
UNSAFE
16
1
P OS .2
6
1 ®
6
1
12
2
3
EN 8 6 7 -1 Cl a s s D
ISO 111 4 0 -1 Cl a s s 5 2
OPTIMUM
18
UNSAFE
14
3
STEAM
INTEGRATOR
20
20
16
1
®
4
Tolerance: -15% time; -1ºC temperature
2
PO
LO T: IT 2 6 0 4 .2 0 0 9 EXP: 0 4 .2 0 1 4
2
1
UNSAFE
IT27 Integron Sequential Indicator Emulator was developed to react in steam sterilization processes. The indicator will show a SAFE result when the sterilization process has reached 134 ºC for 7 minutes or 121 ºC for 20 minutes and the green color will change to black (situation 3). Longer exposure times or higher temperatures will be revealed when the third ink (yellow) changes to black (situation 4). This situation is named OPTIMUM. The blue ink changes to black when exposed to steam, but this change does not ensure the sterilization process efficiency (UNSAFE). ® The Integron IT27 Chemical Indicator is evaluated in BIERs and corresponds to Class 6 according to ISO 11140-1 standard.
18
IT26
3 .5 m i n -1 3 4 ºC / 1 5 m i n -1 2 1 ºC
2
®
Tolerance: -6 % time; -1 ºC temperature
STEAM
INTEGRATOR
Time to go to black (minutes)
IT26 Integron Sequential Indicator Integrator was developed to react in steam sterilization processes. The pink ink was fixed to change to black (situation 3) when the population of spores is completely dead. These results can be obtained when the sterilizer is able to heat the steam at 134 ºC for 3.5 minutes or 15 minutes at 121 ºC. The SAFE result can be extrapolated from the kill time of Bionova® Biological Indicators manufactured according to ISO 11138. Longer exposure times or higher temperatures can be determined when the third ink (green) changes to black. This situation is named OPTIMUM. The blue ink changes to black when exposed to steam, but this change does not ensure the sterilization process efficiency (UNSAFE). ® The Integron IT26 Chemical Indicator is evaluated in BIERs and corresponds to Class 5 according to ISO 11140-1 Standard.
1 SAFE
2 3
1
3
OPTIMUM
IT 27
LO T: I T 2 7 0 4 .2 0 0 9 EXP: 0 4 .2 0 1 4
1
3
®
4
EMULATOR ISO 111 4 0 -1 EN 8 6 7 -1 Cl a s s D Cl a s s 6 2
2
1 ®
STEAM
7 m i n -1 3 4 ºC / 2 0 m i n -1 2 1 ºC
2 3
UNSAFE
1 SAFE
2 3
1
3
OPTIMUM
IT 27
LO T: I T 2 7 0 4 .2 0 0 9 EXP: 0 4 .2 0 1 4
1
3 2 ®
Integrators and Emulators
Integron
Physico Chemical Integrators for Ethylene Oxide ®
Integron IT10 Indicator Integrators have been specifically designed for controlling and monitoring Ethylene Oxide (EO) sterilization cycles since they integrate gas concentration, temperature, exposure time and humidity, the integrator reacts to all these critical parameters for sterilization. A triangle pointer indicates the safety margin on the ® integrators. The pointer indicates the Kill Time of Bionova Biological Indicators for sterilization. This means that the pointer determines the 6 conditions required to kill the entire spore population (10 ) in the biological indicators. Color change of the indicating line on the pointer is related with the sufficient conditions reached by critical parameters which permit to determine the sterility condition.The system was designed to evaluate the EO gas penetration through the sterilization packets. EO gas has to penetrate the polyethylene barrier and react progressively in the capillary system.
1
Phy s ic o Che mic a l Sy s te m
CL ASS 5 / ISO 111 4 0 CL ASS D / EN 8 6 7
3
Phy s ic o Che mic a l Sy s te m
CL ASS 5 / ISO 111 4 0 CL ASS D / EN 8 6 7
2
4
Ph ysico Ch em ical System CLASS 5 / ISO 11140 CLASS D / EN 867
Reference: Pointer (orange triangle) 600mg/L EO – 54º C – 60% RH 45 minutes of exposure.
Phy s ic o Che mic a l Sy s te m
CL ASS 5 / ISO 111 4 0 CL ASS D / EN 8 6 7
Reference obtained on tests carried out in BIER (Biological Indicator Evaluator Resistometer).
Phy s ic o Che mic a l Sy s te m
CL ASS 5 / ISO 111 4 0 CL ASS D / EN 8 6 7
Two Phased Sequential Indicators ®
®
Integron IT12 Integrator Indicators were developed to control ethylene oxide sterilization processes. These products are manufactured with Chemink® high technology inks for sterilization processes. Integron® IT12 are bi-laminated 60 x 25 mm indicators. The inks change sequentially according to exposure time, gas concentration, temperature and humidity. The purple ink was fixed to change to green color (situation 3) when the nominal spore population of Biological Indicators are completely dead. These results can be obtained when the sterilizer reaches 600 mg/L of EO, at 54ºC and 60% RH for 45 minutes. The SAFE result can be extrapolated to the kill time of Bionova ® Biological Indicators manufactured according to ISO 11138 standard.The red ink is used to show the Ethylene Oxide presence but its change to yellow does not ensure the accepted sterilization conditions (UNSAFE). ®
Integron IT12 Chemical Indicator is evaluated in BIERs and corresponds to Class 5 according to EN ISO 11140-1 standard.
EO
INTEGRATOR EN ISO 11140-1 Class 5 2 1
®
EO
IT12
INTEGRATOR EN ISO 11140-1 Class 5 2 1
2
UNSAFE
1
1
L OT: I T12 04.2009 EXP: 04.2014
2
2 1
UNSAFE
1
IT12
SAFE
®
L OT: IT 12 04.2009 EXP: 04.2014
2
2 1 SAFE
®
®
EO
INTEGRATOR EN ISO 11140-1 Class 5 2 1
3
UNSAFE
IT12 1
L OT: I T12 04.2009 EXP: 04.2014
2
2 1 SAFE
®
9
Integrators and Emulators
Integron
Unique Point Indicators IT26-1L; IT26-1S
Integron
STEAM
®
The Integron Unique point Integrator Indicators were developed for monitoring Steam sterilization processes between 121 ºC and 134 ºC and ensures an adequate control on the effectiveness of sterilization processes (temperature, time, quality of steam). The Performance Curve of each integrator can easily determine the safety margin of each of them.
INTEGRATOR
Cycle Verification Indicator
Class 5
EN ISO 11140-1
ORDER CODE
IT26-1
LOT
IT26-L 06.2011
06.2016
MANUFACTURED BY TERRAGENE
Performance Curve 60 30 20
Integron
STEAM ORDER CODE
INTEGRATOR
IT26-1
10
Cycle Verification Indicator EN ISO 11140-1 LOT
Class 5
06.2016
IT26-L 06.2011
Time (min)
MANUFACTURED BY TERRAGENE
5 2 Class 5 IT26-1L, IT26-1S
1
IT27-5.3S; IT27-3.5S; IT27-3.5L; IT27-4L; IT27-7S; IT27-9S; IT27-18S
Geobacillus Stearothermophilus 10
Biologic Indicator
6
®
The Integron Unique point Emulators Indicators ensures an adequate control on the effectiveness of sterilization processes (temperature, time, quality of steam).The wide range of emulators indicators allows to select the indicator that is most suited to the sterilization process to be controlled. The Performance Curve of each Emulator can easily determine the safety margin of each of them.
121
130
135
140
Temperature (ºC)
The graph shows the safety margin regarding the behaviour of a biological indicator and class 5 Integrator.
Performance Curve
3.5 mins 134ºC
60 30 20
STEAM
Cycle Verification Indicator EN ISO 11140-1
IT27-3.5
LOT IT27-3.5 06.2011
IT27-18S IT27-9S IT27-7S IT27-5.3S IT27-4L IT27-3.5L /IT27-3.5S Biological Indicator / class 5
2 1 Geobacillus Stearothermophilus 10
18 mins 134ºC
STEAM
06.2016
121
125
130
135
Integron EMULATOR
ORDER CODE
Cycle Verification Indicator
IT27-18
6
EN ISO 11140-1
MANUFACTURED BY TERRAGENE
LOT IT27-18 06.2011
Class 6 06.2016
140
Temperature (ºC)
®
9 mins 134ºC
The graph shows the safety margin of Integron emulators regarding the behaviour of a biological indicator and class 5 Integrator.
STEAM
3.5 mins 134ºC
Cycle Verification Indicator
IT27-9
Integron
STEAM
EMULATOR
EN ISO 11140-1
Class 6
EN ISO 11140-1
IT27-3.5
LOT
IT27-5.3 06.2011
06.2016
MANUFACTURED BY TERRAGENE
12 mins 121ºC
ORDER CODE
IT27-4 MANUFACTURED BY TERRAGENE
15 mins 121ºC
LOT IT27-9 06.2011
STEAM
Class 6 06.2016
Integron EMULATOR
Cycle Verification Indicator
Cycle Verification Indicator
ORDER CODE
4 mins 134ºC
5.3 mins 134ºC
Integron EMULATOR
ORDER CODE
MANUFACTURED BY TERRAGENE
ORDER CODE
Class 6
EN ISO 11140-1
IT27-5.3
LOT IT27-5.3 06.2011
06.2016
MANUFACTURED BY TERRAGENE
Integron
STEAM
EMULATOR
Cycle Verification Indicator EN ISO 11140-1 LOT
IT27- 4 06.2011
Class 6
06.2016
7 20 mins mins 134ºC 121ºC
STEAM
ORDER CODE
IT27-7 MANUFACTURED BY TERRAGENE
Integron Unique point Integrators and Emulators have great precision, are non-toxic and have a durable laminate that prevents ink transfer to the load during the sterilization process and provides stability during storage. ® ® Integron Unique point Integrators and Emulators were developed with Chemink Chemical technology and tested with stringent quality standards. ® Integron offers a product of easy Interpretation to suit the requirements of each process.
10
Class 6
MANUFACTURED BY TERRAGENE
5
®
Integron EMULATOR
FLASH
ORDER CODE
10 Time (min)
125
Integron EMULATOR
Cycle Verification Indicator EN ISO 11140-1 LOT IT27-7 06.2011
Class 6 06.2016
Integrators and Emulators Integrators and Emulators
Integron
IT28 ®
Integron IT28 Emulator Indicator was developed to control Steam sterilization processes. The indicator will show safe result when the sterilization process has reached 134 ºC for 3.5 minutes or 121 ºC for 15 minutes and it change to black.
Integron
®
Integron IT28 Emulator Indicator has a polyester lamination on one side and the no laminated side can be written. ®
Integron IT28 Emulator Indicator corresponds to Class 6 according to EN ISO11140-1 standard.
Integron
IT30 ®
The Integron IT30 Integrator Indicator was developed to control Dry Heat sterilization processes between 160 ºC and 180 ºC. The blue ink was fixed to change to brown when the population of spores is completely dead. These results can be obtained in Dry Heat sterilization procesess at 160 ºC for 40 minutes. A safe result can be ® extrapolated from the kill time of Bionova Biological Indicators manufactured according to ISO 11138. ®
The Integron IT30 Integrator Indicator corresponds to Class 5 according to EN ISO 11140-1 standard.
Integron
Integron
Humidity Generation Device During EO sterilization process, humidity is a critical parameter which greatly affects the efficiency on sterilization cycles. For EO sterilization systems without humidity generation devices, the efficiency on a ® sterilization cycle can be easily optimized by using Humidigene system. ® Humidigene is a package which issues up to 4 grs. of water steam. ® The steam is gradually issued since Humidigene device should be inserted in a tube through which air circulates. This system prevents the item under sterilization from getting wet. Studies carried out by Terragene® have shown that the sterilization 6 time required to eliminate a 10 spore population from the biological ® indicators is approximately reduced up to 30% when Humidigene system is used. 6
Spores Death Eficience Curve
Spores population
10
With Humidity Generation Device Without Humidity Generation Device
Time The test was made with a Humidigene system in a 20 L Vol. 11
Chemical Indicators
Chemdye
Chemical Indicators for Sterilization Proceses ®
Chemdye Chemical Indicators were developed for monitoring different Sterilization Procecesess: Ethylene Oxide, Steam, Dry Heat, Hydrogen Peroxide or Formaldehyde. ®
Chemdye Auto adhesive Labels and Dots were designed to identify materials (bags, packages, bottles, etc.) exposed to sterilization agents, in hospitals industries, etc ®
Chemdye Internal Control Strips were developed to be used inside the sterilization packages or in a specific place inside the sterilization chamber. ® Chemdye Internal Control Strips permit to write and record the information of the sterilization cycle on the strip. ®
Chemdye Multi-variable Indicators were designed to be used inside sterilization packages or in those places inside the package or chamber were the sterilizer agent cannot access easily. Chemdye® Multi-variable Indicators are paper strips that sense the critical parameters in the different sterilization processes: Ethylene Oxide (temperature, gas concentration, humidity and time), Steam (temperature, steam and time), Dry Heat (temperature and time) or Formaldehyde (temperature, formaldehyde concentration and time). ®
Chemdye Autoadhesive Labels, Auto adhesive Dots and Internal Control Strips are Class 1 Chemical Indicators according to EN ISO 11140-1 Standard. ® Chemdye Multi-variable Indicators are Class 4 Chemical Indicators according to EN ISO 11140-1 Standard.
EO
Auto adhesive Labels Class 1 Indicators
C D11
STEAM
C D11
EO
Turns to Green
C D21 STEAM
EO
Turns to Green
C D21 STEAM
Turns to Green
Turns to Green
Autoadhesive Dots Class 1 Indicators
CD12
Internal Control Strips Class 1 Indicators
EN ISO 1 1 1 4 0 -1 Cl a s s I
EO
Contents
CD12 EN ISO 1 1 1 4 0 -1 Cl a s s I
YELLOW
Red
Initials
EO
YELLOW Initials
CD22 ISO 11140-1 Class I
Date
Red
Contents
®
Cont ent s
®
CD22 ISO 11140-1 Class I
Date
I nit ials
Dat e
®
BLACK
STEA M Blue
Cont ent s
®
BLACK
STEA M Blue
I nit ials
Dat e
Internal Control Double Strips Class 1 Indicators
Final reference Color
Changes to Green
Multi variables Class 4 Indicators
EN ISO 11140-1 CLASS 4 LOT.: CD10 03.2011 EXP.: 03.2016
Final reference Color
Changes to Green
09.2016
CD25 09.2011
09.2016
Contents
Initials
Date
EN ISO 11140-1
STEAM Multiparameter Indicator
Class 4
Turns to black
Turns to green
Date
Contents
Turns to black
Date
Initials
STEAM Multiparameter Indicator
CD25
Class 4
EN ISO 11140-1
CD25 09.2011
CD25
Class 4
Turns to black
Initials
Date
Contents
Class 4
CD15 09.2011
CD15
09.2016
Contents
Initials
Date
EN ISO 11140-1
EO CD15 09.2011
CD15 09.2016
Initials
Multiparameter Indicator
EN ISO 11140-1
CD15 09.2011
STEAM Multiparameter Indicator
CD25
STEAM Multiparameter Indicator
Turns to green
Date
Contents
Class 4
Initials
09.2016
Contents
EN ISO 11140-1
09.2016
EO
CD15
Multiparameter Indicator
EN ISO 11140-1
CD15 09.2011
CD25 09.2011
09.2016
Contents
Multiparameter Indicator
Class 4
Initials
Turns to green
Date
EN ISO 11140-1
EO
Multiparameter Indicator
Class 4
Turns to green
12
EO
CD15
CD25
Double Strips Class 4 Indicators
EN ISO 11140-1 CLASS 4 LOT.: CD10 03.2011 EXP.: 03.2016
Class 4
Turns to black
EN ISO 11140-1
CD25 09.2011
09.2016
Contents
Initials
Date
Chemical Indicators
Chemdye
Chemdye® Chemical Indicators are manufactured in accordance to ISO 9001:2000 and EN ISO 13485:2003 quality management systems.
DRY HEAT
C D31
Turns to Brown
CD32 EN ISO 11140-1 Class I
CD32
Turns to Brown
I nit ials
D RY
Turns to Yellow
®
CD42 EN-ISO 11140-1 Class I
Dat e
FORM
C D41
VH2 O2
Turns to Yellow
Initials
Turns to Green
®
YELLOW Initials
Contents
®
Turns to Green
Initials
Contents
FORM
®
Green Date
®
Green
CD52 FORM Bordeaux EN-ISO 11140-1 Class 1
Date
C D51
FORM
CD52 FORM Bordeaux EN-ISO 11140-1 Class 1
Date
VH2O 2 Pink
Contents
C D51
VH2 O2
YELLOW
VH2O 2 Pink
Contents
®
BLACK I nit ials
CD42 EN-ISO 11140-1 Class I
Dat e
Green
Cont ent s
C D41
DRY
BLACK
Green
Cont ent s
EN ISO 11140-1 Class I
C D31
DRY
D RY
VH2O2
Initials
Date
VH2O 2
Changes to Yellow
Changes to Yellow
VH2O 2 VH2O 2
Changes to Yellow
Changes to Yellow
VH2O 2
Final reference Color
VH2O2 Changes to Yellow
EN ISO 11140-1 CLASS 4 LOT.: CD40 09.2011 EXP.: 09.2011
CD40
Final reference Color
VH2O2 Changes to Yellow
EN ISO 11140-1 CLASS 4 LOT.: CD40 09.2011 EXP.: 09.2011
Initials
Date
Class 4
Turns to green
Turns to green
Date
Multiparameter Indicator
Class 4
FORM
Initials
Contents
Contents
09.2016
09.2016
Contents
Initials
Date
EN ISO 11140-1
VH O CD45 09.2011
CD45 09.2016
EN ISO 11140-1
Multiparameter Indicator
EN ISO 11140-1
CD45 09.2011
09.2016
Contents
FORM
CD55
Multiparameter Indicator
Class 4
Turns to green
EN ISO 11140-1
CD55 09.2011
CD55 09.2011
VH O
CD45
FORM
CD55
CD55
CD45 09.2011
CD45
09.2016
Contents
Multiparameter Indicator
Class 4
Initials
Turns to green
Date
EN ISO 11140-1
VH O
Multiparameter Indicator
Class 4
Turns to green
Turns to black
Date
Turns to green
Date
Turns to green
Class 4
Class 4
Initials
Date
Initials
Contents
Class 4
Contents
09.2016
Initials
CD35 09.2011
CD35
09.2016
Contents
Initials
Date
EN ISO 11140-1
DRY CD35 09.2011
CD35 09.2016
Multiparameter Indicator
EN ISO 11140-1
CD45 09.2011
Multiparameter Indicator
Multiparameter Indicator
EN ISO 11140-1
CD35 09.2011
VH O
CD45
FORM
Turns to black
Date
Contents
Class 4
Initials
09.2016
Contents
EN ISO 11140-1
09.2016
DRY
CD35
Multiparameter Indicator
EN ISO 11140-1
CD35 09.2011
CD55 09.2011
DRY
CD35
CD55
CD40
Date
Initials
Multiparameter Indicator
Class 4
Turns to green
EN ISO 11140-1
CD55 09.2011
09.2016
Contents
Initials
Date
13
09.2016
Contents
Multiparameter Indicator
Class 4
Initials
Turns to black
Date
EN ISO 11140-1
DRY
Multiparameter Indicator
Class 4
Turns to black
Chemical Indicators
Cintape Auto adhesive tapes ®
Cintape Auto adhesive Tapes are designed to make sterilization packages and distinguish the materials that have been exposed to the sterilization process from those which haven’t. Autoadhesive tapes are presented in rolls of 15, 18 and 25 mm wide and 50, 55 o 60 mts long. ® Cintape Auto adhesive Tapes are printed with Chemink® high technology inks and their color changes when they are exposed to the sterilizing agent. Cintape® tapes can be used in Steam, Dry Heat, Ethylene Oxide, Formaldehyde and Hydrogen Peroxide Plasma sterilization processes. ® Cintape products are manufactured with high quality materials, which makes it possible to develop tapes with an excellent adhesivity and high resistance to physical and chemical aggression produced by the different sterilization processes. Cintape ® CT21 is a new type of Auto adhesive tape developed to ® control steam sterilization processes. Cintape CT21 is a dual Chemical Indicator Class 1 and Class 6 manufactured with a novel ink of high technology.
Codes
Initial
121 ºC 10 min. (Class1)
121 ºC 20 min. (Class 6)
134 ºC 2.0 min. (Class 1)
134 ºC 7.0 min. (class 6)
Note: ® Every Cintape roll has a label indicating the batch number and product’s expiration date.
14
Sterilization
Color change
CT10
Ethylene Oxide (OE)
Purple to green
CT20
Steam
Light blue to dark brown Pink to dark brown
CT21
Steam
Green to black (Class 1) Green to purple (Class 6)
CT30
Dry Heat
Blue to brown
CT40
Hydrogen Peroxide (VH2O2)
Pink to yellow
CT50
Formaldehyde
Purple to green
Cintape ® Autoadhesive Tapes are class 1 Chemical Indicators according to EN ISO 11140-1. ® Cintape tapes are developed and manufactured under ISO 9001:2000 and ISO 13485:2003 certified systems.
Chemical Indicators
Chemdye
Autoadhesive Labels for Documentation in Sterilization Processes ®
Chemdye Documentation System was designed to identify and trace sterilization packages exposed to Ethylene Oxide, Steam, Dry Heat, Formaldehyde or Hydrogen Peroxide Plasma sterilization processes. ® Chemdye Documentation Labels have double adhesive and a line printed ® with Chemink process Indicator Inks Class 1, according to ISO 11140-1 standards. Chemdye® Documentation System allows the user to label each sterilization package in a fast and easy way and to relate it with its manufacturing date, expiration date, person in charge of the operation, package content, sterilizer identification and batch number. After opening the package in the operation room, the label can be removed and stuck again to the patient’s ® file or the operation traceability register. This is possible thanks to Chemdye Documentation System’s doble adhesive technology. In the case of nosocomial infections, sterilization information will be available to discard that the infection was caused by non sterile surgical equipment. The three lines labels are presented in rolls of 750 units, per one roll or per 12 rolls.
Process
Not exposed Turns to
Ethylene Oxide
Exposed
Green
Turns to
Recommended Information Initials of the person in charge Sterilizer number Batch number Package content
AR 54 HJ55 Turns to Green
Process Indicator
28.08.2009
Chemdye
®
Manufacture Date
CD
28.09.2009
Process
Green
Expiration Date
Not exposed Turns to
Brown
Exposed Turns to
Brown
Dry Heat Chemdye®
EO
Turns to
CD13
Chemdye®
Green
EO
Turns to
Green
STEAM
CD23
Chemdye®
STEAM
DRY
CD33
Turns to
Steam Chemdye®
Chemdye®
CD13
CD23
Hydrogene Peroxide
Chemdye®
VH2O2
Turns to
Formaldehyde
Chemdye®
Yellow
DRY
Turns to
CD43
Green
FORM
Chemdye®
Chemdye®
Chemdye®
Yellow
VH2O2
Turns to
CD53
CD33
FORM
CD43
Green
CD53
Three line automatic Labeler ®
Chemdye Documentation System includes a manual Labeler with three printing lines of twelve alphanumeric digits per line. Chemdye® CG3 Labeler allows a quick and easy labeling of sterilization packages with the special labels CD13, CD23, CD33, CD43 and CD53.
The benefits of this system: Traceability of the information related to the process and the patient. Easy to remove and stick again thanks to the double adhesive technology.
15
Chemdye Integron
Chemical Integrators and Indicators Emulators
Bowie-Dick Sheets ®
Chemdye Bowie-Dick sheets were developed to control Steam penetration performance. The Bowie-Dick test sheets are designed to be used as indicators placed inside facility assembled standard BowieDick test packs for testing air removal efficiency (134º C for 3.5 minutes) in vacuum assisted steam sterilizer. The sheets are printed with a Chemink ® ink free of heavy metals. The chemical indicator changes from yellow color to uniform black color, indicating adequate air removal. An air removal fault is displayed as a light colored area near the center compared with the marginal areas. Test pack should be placed in horizontal position. Sterilizers which show non-uniform color development shoud be repaired.
Codes
Format
Pack (pcs)
BD20A4
A4
50
BD20A5
A5
50
Bowie-Dick Test Packs ®
Chemdye are pre-assembled single use test packs designed to control steam penetration and air removal performances of pre-vacuum steam sterilizers. The Bowie-Dick Test Packs consist of a series of steam penetration (air removal) barriers into which the chemical indicator sheet is placed. The Bowie-Dick Test Packs is placed near the bottom of an empty sterilizer. During the pre-vaccum cycle, the air must be removed from the barrier and the steam must replace the air throughout the pack. A uniform and complete color change from yellow to black indicates adequate steam penetration. An air removal fault is displayed as a non-uniform color change in some areas or as no color change at all. If there is no color change of the indicator inside the pack after processing it is necessary to check the sterilizer and run a second Bowie-Dick Test. The possible causes of the non-color change are poor quality wet steam, overheated steam and/or non-condensable gas in steam supply. Test pack should be placed in horizontal position. Sterilizers which show non-uniform color change shoud be repaired. Bowie-Dick Test Pack are printed with high performance Chemink ® Inks. Chemdye® Bowie-Dick Test Packs comply with EN ISO 11140-1 standard.
16 1
Codes
Format
Conditions
Colors
BD125X
125x125x26 mm
134 ºC 3,5 min
Yellow to Black
BD125X/1
125x125x16 mm
134 ºC 3,5 min
Yellow to Black
BD125X2
125x125x16 mm
134 ºC 3,5 min
Yellow to Black
BD125X3
125x125x30 mm
134 ºC 3,5 min
Yellow to Black
BD125X16
125x125x26 mm
121 ºC 16,9 min
Yellow to Black
BD125X16/1
125x125x16 mm
121 ºC 16,9 min
Yellow to Black
BD125X16/2
125x125x16 mm
121 ºC 16,9 min
Yellow to Black
BD125X16/3
125x125x30 mm
121 ºC 16,9 min
Yellow to Black
Chemink ®
Inks for Sterilization
High Performance Sterilization Indicator Inks Indicator Inks for sterilization processes lead to the manufacture of different designs of Chemical Indicators used in industrial, medical and hospitals areas. ® The Chemink Inks composition permits their adherence to different types of papers and polyethylene films for flexography and serigraphy printing ® techniques. To determinate if a product has been exposed to a sterilization process is very important. This is why Chemink becomes the most reliable ® product in food and pharmaceutical industries as well as for medical sterilization. Terragene can easily modify the composition of Chemink ® Inks with the aim ® ® of adapting color change to the specific critical parameters for a definite sterilization process. Terragene Chemink Indicator Inks can be designed in a wide ® range of colors depending on our clients’ requirements. Terragene provides high quality and reliable inks at very competitive prices and in different ® presentations which allow to manually label a package or product for sterilization. The Chemink product line includes inks specifically formulated for the following sterilization processes: Steam, Ethylene Oxide, Dry Heat, Hydrogen Peroxide, Formaldehyde and Gamma radiation. ®
There are Water-based and Solvent-based Inks available. Chemink Inks are suitable for printing on various packaging materials such as polyester, ® polypropylene, polyethylene, paper, Tyvek and tapes. ®
Sterilization inks can react according to the pH, porosity and treated surface of the substrates on which they will be applied. Terragene offers the running of tests on each and every substrate required by the customer as a free-of-charge service. By means of this, the formulation of the inks can be specifically adjusted to the characteristics of the material in question, thus assuring the best results of the sterilization inks. ®
Chemink Inks complies to EN ISO 11140-1 standards.
No expuesto / Unexposed Color Inicial / Initial Color
Expuesto / Exposed Color Final / Final Color
No expuesto / Unexposed Color Inicial / Initial Color
Dry Heat
Expuesto / Exposed Color Final / Final Color
Expuesto / Exposed
No expuesto / Unexposed
Color Final / Final Color
Color Inicial / Initial Color
Formaldehyde
Steam
Navy Blue
IK30
Sea Green
Dark Grey
IK20
Brick Orange
Bordeaux
IK50
Deep Purple
IK31
Pale Brown
Navy Blue
IK21
Pale Brown
Paled Red
IK51
Old Pink
IK32
Sandy Brown
Old Pink
IK22
Wheat Brown
Dark Green
IK33
Dark Brown
Yellow
IK23
Black
IK34
Brown
White
IK24
Black
Old Pink
IK25
Black
Sky Blue
IK26
Black
Light Green
IK27
Black
Light Purple
IK28
Green
Blue
IK29
Pale Pink
Green
IK200
Red Purple
Blue
Ethylene Oxide Green
Purple
IK11
Fuchsia
Dark Red
IK12
Yellow
Red Purple
IK13
Light Green
Pink
IK14
Brown
Ocean Blue
IK15
Brown
White
IK16
Brown
Ocean Blue White Pink Sky Blue
IK17
Olive Yellow
IK18
Sun Yellow
IK19
IK100
Light Yellow Green
Gamma Radiation Gold
Red
IK70
Light Green
Pale Purple
Plasma H2O2
IK10
Sandy Yellow
Green
Gold Fluo Green
Lilac
IK40
Green
Sky Blue
IK41
Fluo Green
Pink
IK42
Gold
Violet
IK43
Dark Green
ADIK3
Retardant Drying and Cleaner : To retard the time of drying and to clean mesh for serigraphy inks.
CCRS2 CCAS2 CCAS3 CCAS4
Color Change Retardant Solution: To delay the color change of flexography and serigraphy water based inks for ETO IK12/13. Color Change Acelerator Solution: To acelerate the color change of flexography and serigraphy water based inks for ETO IK12/13. Color Change Acelerator Solution: To acelerate the color change of flexography and serigraphy water based inks for STEAM (IK20 to IK22) and Dry Heat. Color Change Acelerator Solution: To acelerate the color change of flexography and serigraphy water based inks for STEAM (IK23 to IK27).
SOLVINK
Type I Extender: To dilute solvent-based inks, to reduce the viscosity and to be used as a cleaner solution for flexography inks.
AMMS WAISO
Ammonia Solution 2.8%: To dilute water based inks for ETO and FORM. Type II Extender: To dilute water based inks, to reduce the viscosity of serigraphy and flexography inks for STEAM (IK23 to IK27).
SOLVNITRO
Type III Extender: To dilute solvent based inks, to reduce the viscosity of serigraphy and flexography inks for VH2O2 (IK40 to IK42).
COATPVC
Coating for inks IK23F to IK27F. Protection of the steam washing efect and improving the signal color. Avoiding the tranferetion of the ink in tapes production.
COAT9104PMIN Coating for all steam inks . Protection of the steam washing efect and improving the signal color. Avoiding the tranferetion of the ink in tapes production.
Terragene can change the formulation for improving Version 9-2011
17
Te r ra g e n e S . R . L . Catamarca 2518 - S2000JRH Rosario - Santa Fe - Argentina - mail: info@terragene.com.ar - web: www.terragene.com.ar Sistemas de Gestión de la Calidad Certificados / Certified Quality Management Systems ISO 9001 : 2008 Nº: 22095-2008-AQ-ARG-NA ISO 13485 : 2003 Nº: 22094-2008-AQ-ARG-NA H a b i l i t a c i ó n d e l a Ad m i n i s t ra c ó n Na c i o n a l d e M e d i c a m e nto s, Al i m e nto s y Te c n o l o g í a M é d i c a ( A . N . M . A . T. ) - D i s p. 4 9 / 0 7 . B u e n a s Pr á c t i c a s d e Fa b r i c a c i ó n ( N º 8 5 4 1 / 0 6 - 0 ) . Au t h o r i ze d by Nat i o n a l Ad m i n i s t rat i o n o f M e d i c i n e s, Fo o d a n d M e d i c a l D ev i ce s ( A . N . M . A . T. ) - R e g u l at i o n 4 9 / 0 7 . G o o d M a n u f a c t u re Pra c t i ce s ( N ª 8 5 4 1 / 0 6 - 0 ) . Los productos descriptos en este catálogo son fabricados integramente por Terragene S.R.L. El catálogo tiene fines descriptivos y publicitarios exclusivamente, las especificaciones e instrucciones de uso son proporcionadas en el envase de cada producto. The products described on this brochure are entirely manufactured by Terragene S.R.L. The brochure is issued only with descriptive and advertising aims. The products specifications and descriptions for use are provided in each product container. www.terragene.com.ar www.terragene.asia info@terragene.com.ar
Phone: (+54) 341-4362015 / 4306245