Terragene Sterilisation Control – Chemical Indicators

Bowie & Dick Tests (Type 2)

• Terragene Chemdye Bowie & Dick tests were developed to control air removal and steam penetration performance in vacuum-assisted steam sterilisers.
• Terragene Chemdye Bowie & Dick tests are single-use devices that consist of a lead free chemical indicator, BD test sheet, placed between porous sheets of paper, wrapped with crepe paper with a Steam indicator label on the top of the package.
• Terragene Chemdye Bowie & Dick BD125X/1 also includes a warning sheet which contains a circular lead free chemical indicator, which allows an early detection of air removal failures before they appear on the central chemical indicator.

BD125X/1 – Cycles of 132°C for 4 minutes and 134°C at 3.5 minutes with Warning Sheet, from Yellow to Dark Brown/Black, ISO 11140-5
BD125X/2 – Cycles of 16.9 minutes at 121°C, 4 minutes at 134°C and 3.5 minutes at 134°C, from Yellow to Dark Brown/Black, ISO 11140-4
BD125X10/2 – Cycles of 10 minutes at 121°C, from Yellow to Dark Brown/Black, ISO 11140-4
BDA4 – A4 Size, Cycles of 3.5 minutes at 134°C, 4 minutes at 132°C, from Yellow to Dark Brown/Black, ISO 11140-3
BDA4/1 – A4 Size, Cycles of 3.5 minutes at 134°C, 4 minutes at 132°C, from Yellow to Dark Brown/Black, ISO 11140-5
BDA51 – A5 Size, Cycles of 3.5 minutes at 134°C, 4 minutes at 132°C, from Yellow to Dark Brown/Black

Bowie & Dick Test Card (Type 2)

• Terragene Chemdye Bowie & Dick Test Card has been designed to monitor the effectiveness of air removal in vacuum-assisted steam sterilisers at 132°C for 4 minutes and at 134°C at 3.5 minutes.
• Chemdye Bowie & Dick Test Card consists of a Type 2 metal free chemical indicator printed on one side of the card.
• The Chemical indicator will change from purple to green when processed.
• A non-uniform colour change with Terragene’s Chemdye Bowie & Dick Test Card indicates presence of an air pocket during the sterilisation cycle, therefore indicating sterilisation malfunction.

BD8948X – Steam Sterilisers operating at 3.5 minutes at 134°C and 4 minutes at 132°C, Purple to Green, ISO 11140-4
BD8948X1 – Steam Sterilisers operating at 3.5 minutes at 134°C and 4 minutes at 132°C, Purple to Green, ISO 11140-5
KBD8948 – Steam Sterilisers operating at 3.5 minutes at 134°C and 4 minutes at 132°C, Purple to Green, Kit
KBD8948X1 – Steam Sterilisers operating at 3.5 minutes at 134°C and 4 minutes at 132°C, Purple to Green, Kit

Process Challenge Devices (PCD) Helix Type and Specific Indicators (Type 2)

• Terragene Helix Process Challenge Devices are designed to evaluate the safe release of the steriliser load, especially for hollow instruments.
• Terragene Specific Indicators offer a range of Type 2 indicators for Steam, Ethylene Oxide (Eto / EO), Formaldehyde (LTSF) and Hydrogen Peroxide (H₂O₂)
• Terragene Helix PD provides a Bowie & Dick simulation test to monitor the sterilisers performance, empty.

Metal Capsule PCD for STEAM

CDPCD2X025/M, 0.25 m Long
CDPCD2X050/M, 0.5 m Long
CDPCD2X075/M, 0.75 m Long
CDPCD2X10/M, 1 m Long
CDPCD2X15/M, 1.5 m Long
CDPCD2X30/M, 3 m Long
CDPCD2X45/M, 4.5 m Long

Plastic Capsule PCD for STEAM, ETHYLENE OXIDE, FORMALDEHYDE, HYDROGEN PEROXIDE

CDPCD2X025/P, 0.25 m Long
CDPCD2X050/P, 0.5 m Long
CDPCD2X075/P, 0.75 m Long
CDPCD2X10/P, 1 m Long
CDPCD2X15/P, 1.5 m Long
CDPCD2X30/P, 3 m Long
CDPCD2X45/P, 4.5 m Long

Indicators for Helix System

PCD-A-3.5Y, Steam, 3.5 minutes at 134°C, Black to Yellow
PCD-A-5.3Y, Steam, 5.3 minutes at 132°C or 15 minutes at 121°C, Black to Yellow
PCD-A-7.0Y, Steam, 7 minutes at 132°C or 20 minutes at 121°C, Black to Yellow
PCD-A-9.0Y, Steam, 9 minutes at 134°C, Black to Yellow
PCD-A-18.0Y, Steam, 18 minutes at 134°C, Black to Yellow
PCD-A-E1, Ethylene Oxide, Sky Blue to Green
PCD-A-F1, Formaldehyde, Bordeaux/Red to Green
PCD-A-P1, Hydrogen Peroxide, Purple to Green
PCD-A-3.5BD, Bowie & Dick Simulation Test, Steam, 3.5 minutes at 134°C, Blue to Black

Chemdye Type 4 Chemical Indicators

• Terragene Chemdye Type 4 internal control strip indicators are designed to rapidly show if critical parameters of the sterilisation process have been reached, ensuring appropriate penetration of the sterilising agent inside the package.
• Terragene Chemdye chemical indicators offer a distinct colour change when exposed, to ensure the stated values (SVs) of the critical process variables.

Chemical Indicator Strips (Type 4)

CD16, Ethylene Oxide (EtO / EO), 600 mg/l EO, RH 60%, 30°C for 30 minutes or 600 mg/l EO, RH 60%, 54°C for 20 minutes, Purple to Brown, Double Strips
CD20, Multi-variable, Steam, 121°C for 15 minutes or 134°C for 3.5 minutes, Purple to Green
CD22, Steam, 121°C for 10 minutes or 134°C for 2 minutes, Blue to Black
CD202, Multi-variable, Steam, 121°C for 15 minutes or 134°C for 3.5 minutes, Blue to Black, Double Strips
CD29, Multi-variable, Steam, 121°C for 15 minutes or 134°C for 3.5 minutes, Yellow to Dark Brown/Black, Double Strips
CD29-AD, Multi-variable, Steam, 121°C for 15 minutes or 134°C for 3.5 minutes, Yellow to Dark Brown/Black, Self Adhesive Double Strips
CD30, Multi-variable, Dry Heat, 160°C for 40 minutes or 180°C for 20 minutes, Dark Blue to Brown
CD32, Dry Heat, 160°C for 40 minutes, Dark Blue to Brown
CD40, Hydrogen Peroxide (H₂O₂), 6 minutes for 50°C, 2,3 mg/l H₂O₂, Purple to Green
CD42, Hydrogen Peroxide (H₂O₂), 6 minutes for 50°C, 2,3 mg/l H₂O₂, Red to Yellow
CD50, Multi-variable, Formaldehyde (LTSF), 30 minutes for 60°C, 1 mol/l FORM, Bordeaux/Red to Green

Chemical Tubes (Type 4)

CD210, Multi-variable Glass Ampoule, Steam Sterilisation of Fluids, 121°C for 15 minutes or at 126°C for 10 minutes, Black Spot, Red to Green
CD220, Multi-variable Glass Ampoule, Steam Sterilisation of Fluids, 134°C for 3 to 3.5 minutes, Yellow Spot, Red to Green
CD250, Multi-variable Glass Ampoule, Dry Heat, 160°C for 120 minutes, 170°C for 60 minutes or 18°C for 35 minutes, White Spot, Red to Green

Moving Front Chemical Integrators / Indicators (Type 5)

• Terragene Integron moving front integrators were developed for monitoring steam sterilisation processes between 118°C and 13°C, by monitoring all critical parameters of steam sterilisation (temperature, time, steam quality).
• Chemical pellets melt and migrates as a dark bar along the paper wick, through a zone marked as ACCEPT or REJECT, thus indicating whether sterilisation conditions were met or not.

Unique Point Chemical Integrator (Type 5)

• Terragene Integron Unique Point Integrators were developed for verification of Steam sterilisation cycles between 121°C and 135°C.
• Terragene Integron Unique Point Integrators ensure an adequate control of the effectiveness of sterilisation processes (temperature, time, steam quality).

EO Two Level Integrator (Type 5)

• Terragene Two Level Integrator were developed to control Ethylene Oxide sterilisation process.
• The two level indicator was designed for: Level 1, is the exposure level which indicates exposure to Ethylene Oxide and Level 2 is the integration level, consisting of a purple/brown ink dot that turns to green as it integrates all the critical parameters of sterilisation process (time, temperature, humidity and Ethylene Oxide concentration).
• The Terragene EO Two Level Integrator mimics the death curve of a theoretical Bacillus atrophaeus spore population.

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