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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

catalogue 2012  

Sterilization Controls DivisionCatálogo - Catalogue2012-2013

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