Sterilization Monitoring & Validation

Mini Self-Contained Biological Indicators (MSCBIs) for monitoring Steam processes consist of:

• A polypropylene vial and cap
• A crushable media ampule which contains modified Tryptic Soy Broth (TSB) with a pH indicator. The modified TSB will transition from the initial Purple color to Yellow and/or demonstrate turbidity in the presence of bacterial growth.
• An inoculated carrier (disc) of Geobacillus stearothermophilus Cell Line 7953 with a population level of 106 . 

Physical Properties

• Process: Steam
• Dimensions 8.3 mm x 46 mm
• Packaging 100 per box
• Chemical Indicator: Each MSCBI contains a Chemical Indicator (CI) on the vial label. The CI should transition from Pink to Brown when exposed to a steam process.  

Additional Information:

• Item Code: MSCST-06
• Minimum Order Quantity: 100 Piece
• Production Capacity: 10000
• Delivery Time: Ex-Stock

Product Details:

Autoclavable & EO Tapes

Features

• The process indicator tape is designed to seal packs that are exposed to steam sterilization. The tape distinguishes between items processed and unprocessed in both gravity discharge and ve-vacuum steam sterilizationprocesses.
• Designedfor use in gravity sterilizers operating at 121°C for 30 minutes or pre-vacuum sterilizers operating at 132°C for 4 minutes and 135°C for 3 minutes.
• Easy-to-handle, adheres on contact and stays in place through live steam pressure.
• After use, the tape removes Quickly and completely.
• Made of a saturated crepe paper printed with a lead-free ink, the green indicator lines turn black once exposed to steam process. It is coated with a synthetic elastomer adhesive.

Product Description Mini Self-Contained Biological Indicators (MSCBIs) for monitoring (EO) processes consist of:

A polypropylene vial and cap
A crushable media ampule which contains modified Tryptic Soy Broth (TSB) with a pH indicator. The modified TSB will transition from the initial Green color to Yellow and/or demonstrate turbidity in the presence of bacterial growth.
An inoculated carrier (disc) of Bacillus atrophaeus Cell Line 9372 with a population level of 10

True Indicating Codes: ST-04, ST-05 and ST-06

Biological indicator Spore Strips for monitoring Steam processes consist of:

• An inoculated carrier, 6mm x 30mm strip of Geobacillus stearothermophilus Cell Line 7953
• Primary packaging in glassine envelopes

Physical Properties

Process: Steam Strip
Dimensions: 6mm x 30 mm
Glassine Dimensions Envelope 30mm x 38mm
Packaging 100 / Pack

Additional Information:

• Item Code: ST-06
• Minimum Order Quantity: 100 Piece
• Production Capacity: 10000
• Delivery Time: Ex-Stock
• Packaging Details: 100 Pcs/Pack

True Indicating Multi-critical Process Variable Indicator Strips contain no lead or other toxic heavy metals. The Indicator Strips are intended for use with individual materials (i.e pouches, pack. Tray) to demonstrate that the material has been exposed to a steam sterilization process to distinguish between processed and unprocessed goods. The indicator strips will transition from an initial Yellow color to a Dark/Black color when exposed to steam. 

Physical Properties 

 

 

Type 4 Multi-Critical Process Variable Indicator: 

 121°C, 15 minutes 

 134°C, 3.5 minutes 

Additional Information:

• Item Code: CSYN-14
• Minimum Order Quantity: 1 Pack
• Production Capacity: 1000
• Delivery Time: Ex-Stock
• Packaging Details: 250 Strips / Pouch

True Indicating Integrating Indicator strips contain no lead or other toxic heavy metals. The Indicator Strips monitor whether sterilisation conditions were met at the point of placement of the strip. The Indicator Strips are intended for use in steam sterilizers operating at 121°C and up to 135°C. Type 5 integrating indicators react to all critical variables (time, temperature and moisture) and reach an end point indicating exposure to sterilisation conditions at defined by True Indicating’s stated values. 

 

Physical Properties 

 

Indications for Use 

Type 5 Integrating indicator stated values 

 121°C, 16.5 minutes (pre-vacuum) 

 135°C, ≥1.2 minutes (pre-vacuum) 

Additional Information:

• Item Code: CSPN-15
• Minimum Order Quantity: 1 Pack
• Production Capacity: 1000
• Delivery Time: Ex-Stock

True Indicating Emulating Indicator Strips contain no lead or other toxic heavy metals. The Indicator Strips monitor whether sterilization conditions were met. The Indicator Strips transition from Blue to Dark with the word “NOT” being completely concealed with effective conditions. The Indicator Strips are intended for use in steam sterilizers operating at 121°C and up to 134°C. Type 6 Emulating Indicators react to all critical vari-ables (time, temperature and moisture) and reach an end point color indicating exposure to conditions as defined by True Indicating’s stated values. 

Process Parameter

 

Indications for Use 

Type 6 Emulating Indicator stated values: 

121°C, 10 minutes 

134°C, 3.5 minutes 

Additional Information:

• Item Code: CSBN-16
• Minimum Order Quantity: 1 Pack
• Production Capacity: 1000
• Delivery Time: Ex-Stock
• Packaging Details: 250 Strips / Package

Geobacillus stearothermophilus Spore Suspensions for monitoring Steam sterilization processes consist of:

• Pure suspension of viable spores with a known population and resistance
• Packaged in a vial with screw cap and septum for access with a syringe or pipette

Additional Information:

• Item Code: UT-06
• Minimum Order Quantity: 10 Piece
• Production Capacity: 100
• Delivery Time: 4 WEEKS.

Dry Heat Ampules for monitoring Dry Heat sterilization processes consist of: 

 Snap top glass ampule containing silica material inoculated with Bacillus atrophaeus Cell Line 9372 Spores with a known population and resistance. 

 Tubes of growth medium specially formulated for Bacillus atrophaeus modified with a pH indicator that transitions from Green to Yellow and offers a reduced incubation time of 72 hours. 

 All materials are compatible with extremely high temperatures such as those in dry heat tunnels or ovens used for sterilization or depyrogenation in manufacturing of aseptically filled pharmaceutical liquids. 

True Indicating steam Chemical Process Indicator labels contain no lead or other toxic heavy metals. The Indicators are manufactured to monitor whether exposure conditions were met at the point of placement of the indicator. The indicators are designed for use in steam sterilizers operating at 121°C to 137°C.

Physical Properties:

Process: Steam
Dimensions: 12 mm (1/2”) Dot
Packaging: 5,000 Indicators/Roll
Chemical Indicator: Initial Color: Blue
Signal Color: Pink

Additional Information:

• Item Code: CSBP-1
• Minimum Order Quantity: 1 Pack
• Production Capacity: 1000
• Delivery Time: Ex-Stock

True Indicating Bowie Dick (BD) Test Packs contain no lead or other toxic heavy metals and are made of recyclable materials. The Test Packs contain an internal Indicator sheet which is used to evaluate the effi-cacy of air removal and steam penetration in pre-vacuum sterilizers. A uniform color change to Pink of the internal Indicator sheet provides evidence that the sterilizer has successfully removed air and can allow steam to penetrate a load placed in the chamber. The Test Packs are for use in pre-vacuum steam steriliz-ers operating at 121°C and 134°C. The Test Packs simulate a 7kg cotton pack according to ISO 11140-4 Type 2 and EN 867-4 Class B. 

 

Physical Properties 

 

 

Indications for Use 

Type 2 Indicator 

 121°C, 15 minutes (pre-vacuum) 

 134°C, 3-3.5 minutes (pre-vacuum) 

Additional Information:

• Item Code: BD-1X
• Minimum Order Quantity: 20 Piece
• Production Capacity: 10000
• Delivery Time: Ex-Stock