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M-100

The M-100 Cryoguard™ Thermal Exposure Indicator

Product Description

new-indicator-picture-with-buy-now.jpgThe M-100 Cryoguard Thermal Exposure Indicator signals thermal exposure at or above -100°C by irreversibly changing color from green to red. Upon transfer from an initial environment at or below -125⁰C to an environment at -100⁰C, the indicator exhibits a noticeable color change within one hour. The time to affect a color change dramatically decreases with increasing temperature, as illustrated in the figure below. At 25⁰C, the time required to affect a color change is 2.5 minutes. The distinct real-time signal allows recipients and users of perishable cryopreserved materials to quickly and reliably verify the maintenance of cryo-environments.

Product Applications

1. Continuous monitoring of frozen materials during shipping.

2. Continuous monitoring of frozen materials while being inspected by customs agents.

3. Continuous monitoring of frozen materials during storage.

4. Continuous monitoring of frozen materials during power outages when freezer control systems are not working.

5. Continuous monitoring of frozen materials during their transient removal from freezers for handling by personnel.

6. Continuous monitoring of materials in dry shippers.

7. Indicators fit inside freezer box partitions and on cryovials and freezer canes.

 

M-100 indicators are used at or below -125⁰C to monitor materials such as labile laboratory specimens, stem cells, orthopedic grafts, blood products, vascular tissue including heart valves, and cell therapy products.

 

Technical Specifications

What Does a Green M-100 Indicator Signify?

A completely green indicator (with no red or colorless regions) means that the material in the vicinity of the indicator was never at -100⁰C for more than two hours or at -90°C for more than 12 minutes or at -70°C for more than 9 minutes or at -40°C for more than 3 minutes.

The graph below shows the time required at various test temperatures to affect a 10-100% color change, upon transfer of the M-100 indicator from an environment at or below -125°C to an environment at the plotted test temperature. 

 

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Activation of the M-100 Indicator

The activation process involves freezing the indicator, removing it from the cryo-environment, depressing its activation pin, and immediately re-freezing the indicator to a temperature at least 25⁰C below the signal temperature. Indicators should be activated and re-frozen one at a time in order to minimize time between these two steps. After re-freezing, the indicator is ready to monitor the desired environment.

***For more detailed activation information, please visit the Activation Guide page. 

Note: When handling frozen indicators, one should avoid contact with bare hands to prevent heat transfer and freeze burn.

Recommended Procedure:

  1. Completely freeze the indicator. This may be done by placing it in an environment at or below -125°C for one hour or by immersing it in liquid nitrogen on a freezer cane for ~5 minutes. Freezing with the pin up allows for easier activation.

  2. Remove the indicator from the cold environment.

  3. Wait 0-10 seconds if the indicator was frozen at -125°C or 30-40 seconds if it was frozen in liquid nitrogen to sufficiently thaw the indicator so that the pin can be depressed without excessive force. Indicators frozen for longer than the minimum freezing time in step 1 may require longer thawing times to activate the indicator without applying excessive pressure which may bend the pin or damage the activation mechanism.     

  4. Press the activation pin into the indicator until flush with the indicator body. The pin may be depressed using channel lock pliers, our Cryoguard Activation Tool, or by pushing against a hard flat surface. Do not use extreme impact such as a hammer blow to depress the pin, as this can damage the activation mechanism.

  5. Rapidly refreeze the indicator to a temperature at or below -125°C. This prevents a premature thermal exposure signal and readies the indicator for monitoring. The indicator temperature can be rapidly lowered below -125°C by immersing the indicator in liquid nitrogen for ~5 minutes.

  6. Place the indicator in the environment to be monitored either on its side or in a vertical positon with the label end up.

Coolant Compatibility

The indicator can be used in contact with liquid nitrogen, liquid nitrogen vapor phase, and with frozen materials in dry shippers and mechanical freezers.

Shelf-life and Storage

Indicators are shipped ~8 months prior to their expiration date, which appears on the indicator label. Whether activated or not, indicators should not be used after the expiration date. Unactivated indicators may be stored at 15° to 30°C. Activated and unactivated indicators may be stored at or below -190°C in liquid nitrogen or vapor phase liquid nitrogen. Warning: Protective shielding including safety glasses and gloves should be used when handling indicators that have been submersed in liquid nitrogen to prevent injury in the unlikely event that the indicator shatters upon removal from the liquid nitrogen. If using cold storage, it is best to avoid bringing unactivated indicators back to room temperature prior to activation, since this fluctuation of temperature may prematurely activate the indicators.

Size and Packaging

Indicators are sealed in a plastic housing approximately 1" long and 0.5" in diameter. The indicator housing contains eyelets for wiring it to the monitored material. An alert label for affixing to containers monitored by the indicator is supplied with each indicator. The alert label is a 1" x 4.25" bright orange-red peel and stick adhesive label.

Chemical Composition

Indicator solutions have an approximate volume of 1 mL per unit and are comprised of buffered mixtures of aqueous dyes, alcohols, glycols and water. Indicators may be safely discarded as standard waste.

Quality Assurance

Several indicators in each batch are tested in a Model 7450 CryoMed Controlled Rate Freezer using NIST calibrated thermocouple thermometers to verify that the indicators in each batch perform as specified above.

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X-ray Irradiation Notice

Although Cryoguard indicators can be safely exposed to x-rays from diagnostic and security scanners, the indicators should not be exposed to ionizing x-ray radiation. Exposure to ionizing x-rays will permanently deactivate the indicator, causing it to lose its ability to signal thermal exposure. Indicators may still be used with irradiated products, after the products have been irradiated. 

Pricing Information for M-100 Indicators 

Box of 10 Box of 25 Box of 50
     $163     $326     $625