WarmMark QR and FreezeSafe QR
WarmMark QR and FreezeSafe QR are single-use, battery-free temperature indicators designed to help monitor temperature-sensitive products during shipping and storage. WarmMark QR monitors ascending temperature, or exposure above a specified temperature threshold, while FreezeSafe QR monitors descending temperature, or exposure below a specified threshold.

Both provide irreversible visual indication with QR-enabled digital documentation, allowing shipment condition information to be captured with a smartphone and stored in the SpotSee Cloud.

What is the difference between WarmMark QR and FreezeSafe QR?
WarmMark QR and FreezeSafe QR monitor opposite types of temperature exposure.

WarmMark QR is an ascending time-temperature indicator. It monitors cumulative exposure above a specified temperature threshold and indicates when defined time-temperature conditions have been met.

FreezeSafe QR is a descending temperature indicator. It provides visual evidence when the indicator has been exposed below a specified temperature threshold.

The right solution depends on whether a product is sensitive to excessive heat, excessive cold or both.

What is an ascending temperature indicator?
An ascending temperature indicator monitors exposure above a specified temperature threshold.

WarmMark QR is designed to monitor ascending temperature exposure. It is particularly useful for products where both the temperature reached and the duration of exposure can matter.

When the defined time-temperature conditions are met, its visual indicator changes irreversibly from white toward red or pink.

What is a descending temperature indicator?
A descending temperature indicator monitors exposure below a specified temperature threshold.

FreezeSafe QR is designed to identify unacceptable descending temperature exposure. When the indicator is exposed below its activation threshold for the required conditions, it changes visually to provide irreversible evidence of the exposure.

When should I use WarmMark QR?
WarmMark QR should be considered when a product could be affected by exposure above a specified temperature.

It can be used for temperature-sensitive products such as:

  • Pharmaceuticals
  • Biologics
  • Vaccines
  • Diagnostic materials
  • Clinical trial shipments
  • Specialty medications
  • Food and beverage products
  • Other products sensitive to excessive heat exposure

The selected temperature threshold and run-out time should match the specific product requirements.

When should I use FreezeSafe QR?
FreezeSafe QR should be considered when a product could be affected by exposure below a specified temperature.

Applications can include:

  • Pharmaceuticals
  • Vaccines
  • Clinical trial materials
  • Diagnostic products
  • Food and beverage products
  • Chemicals and specialty materials
  • Other products sensitive to excessive cold exposure

The selected temperature threshold should match the product’s validated temperature requirements.

Can WarmMark QR and FreezeSafe QR be used together?
Yes.

For products with both upper and lower temperature limits, WarmMark QR can monitor exposure above a specified threshold while FreezeSafe QR can monitor unacceptable descending temperatures.

Together, they can provide visual and QR-enabled evidence for both sides of a defined temperature range.

What is a time-temperature indicator?
A time-temperature indicator responds to both temperature and duration of exposure.

WarmMark QR monitors cumulative exposure above its specified threshold. Different configurations are available with specific temperature thresholds and run-out times to address products with different temperature and exposure requirements.

What is a WarmMark QR run-out time?
Run-out time refers to the approximate cumulative exposure required for a WarmMark QR indicator to progress through its indication at temperatures above its specified threshold.

Different products tolerate different combinations of temperature and time, which is why WarmMark QR is available in multiple threshold and run-out configurations.

What temperature thresholds are available for WarmMark QR?
SpotSee offers WarmMark QR configurations for several temperature thresholds and exposure durations, including options for temperatures such as -18°C, 0°C, 5°C, 8°C, 10°C, 25°C, 26°C, 30°C and 37°C.

Available run-out times vary by configuration.

The appropriate model should be selected according to the product’s validated temperature requirements rather than simply choosing the closest temperature.

What temperature thresholds are available for FreezeSafe QR?
FreezeSafe QR is available in several descending temperature thresholds:

  • 0°C / 32°F
  • 2°C / 36°F
  • 5°C / 41°F
  • 10°C / 50°F
  • 15°C / 59°F

The appropriate threshold should be selected according to the minimum acceptable temperature for the product being monitored.

Are WarmMark QR and FreezeSafe QR temperature data loggers?
No.

WarmMark QR and FreezeSafe QR are temperature indicators, not electronic data loggers. They do not continuously record and store a complete temperature history.

WarmMark QR provides an irreversible visual indication based on cumulative exposure above its threshold, while FreezeSafe QR provides visual evidence of defined descending temperature exposure.

QR scans create digital data points associated with the indicator and shipment.

Do WarmMark QR and FreezeSafe QR require batteries?
No.

Both WarmMark QR and FreezeSafe QR are battery-free and do not require an electronic reader to monitor temperature exposure.

This makes them practical for package-level, item-level and last-mile applications where deploying an electronic logger on every shipment may not be necessary, or is cost/logistics prohibitive.

Do recipients need to download an app to scan WarmMark QR or FreezeSafe QR?
No. Both indicators can be scanned with a compatible smartphone without requiring a dedicated app download.

This can simplify condition checks at receiving locations and in last-mile applications involving pharmacies, clinics, laboratories, distributors, patients and other recipients.

What information is captured when WarmMark QR or FreezeSafe QR is scanned?
A QR scan can create a digital record containing information such as:

  • Time and date
  • Location
  • Indicator serial number
  • Indicator condition or status
  • Image of the indicator

The information can be sent to the SpotSee Cloud, creating a retrievable record associated with the shipment or indicator.

What should I do if a WarmMark QR or FreezeSafe QR indicator has activated?
An activated indicator means the conditions required to trigger its response have occurred.

Recipients should follow the instructions supplied by the sender and contact the sender if required.

For pharmaceuticals, biologics or other temperature-sensitive products, do not assume that an activated indicator automatically means the product is safe or unsafe. Product disposition should follow the manufacturer’s stability data and the organization’s established quality procedures.

Does an activated temperature indicator mean the product is unsafe?
Not automatically.

WarmMark QR and FreezeSafe QR indicate that a predefined temperature condition has occurred. Determining whether the product can still be used requires product-specific stability information and the appropriate quality or clinical decision process.

The indicators provide evidence to support that decision rather than making the final disposition decision themselves.

How do WarmMark QR and FreezeSafe QR help with cold chain receiving?
WarmMark QR and FreezeSafe QR give receiving teams an immediate visual indication of temperature conditions experienced by the indicator.

The QR code adds a digital documentation step, allowing recipients to record the observed condition at receipt along with information such as time, location and indicator identification.

This can support more consistent receiving, quarantine and escalation processes when a temperature excursion may have occurred.

Can WarmMark QR and FreezeSafe QR be used for pharmaceutical shipments?
Yes. WarmMark QR and FreezeSafe QR can support temperature monitoring for pharmaceutical and life science shipments when the selected thresholds align with the product’s validated requirements.

WarmMark QR can monitor ascending temperature exposure while FreezeSafe QR can monitor descending temperature exposure.

Can WarmMark QR and FreezeSafe QR be used for ship-to-home medications?
Yes. QR-enabled temperature indicators can support ship-to-home and direct-to-patient temperature monitoring.

Recipients can visually inspect the indicator and scan its QR code using a compatible smartphone without downloading a dedicated app.

The sender should define clear instructions explaining what recipients should do based on the indicator condition.

How do I monitor both excessive heat and cold during shipping?
Products vulnerable to both upper and lower temperature excursions may require both ascending and descending temperature monitoring.

WarmMark QR monitors cumulative exposure above a specified temperature threshold, while FreezeSafe QR monitors exposure below a specified temperature threshold.

Using the two together can provide evidence for both sides of a product’s defined temperature range.

How do I choose between WarmMark QR and FreezeSafe QR?
Start with the product’s validated temperature range and allowable exposure conditions.

Choose WarmMark QR when the primary concern is ascending temperature or cumulative exposure above a maximum temperature.

Choose FreezeSafe QR when the primary concern is descending temperature or exposure below a minimum temperature.

Consider both when the product has defined upper and lower temperature limits and either type of excursion could affect product condition.

How do WarmMark QR and FreezeSafe QR support cold chain traceability?
WarmMark QR and FreezeSafe QR turn individual scans into structured digital data points.

Instead of relying only on the physical indicator, teams can associate the observed condition with information such as scan time, location, indicator condition, and serial number in the SpotSee Cloud.

Across multiple shipments, these records can help quality and logistics teams investigate recurring excursion patterns and improve cold chain processes.

Do WarmMark QR and FreezeSafe QR replace validated cold chain packaging?
No.

WarmMark QR and FreezeSafe QR provide condition monitoring and evidence of temperature exposure. They do not replace validated packaging, qualification studies, handling procedures or other controls needed to maintain an appropriate shipping environment.

They can be used as an additional layer of visibility within a broader cold chain program.

Where can I buy WarmMark QR and FreezeSafe QR?
WarmMark QR and FreezeSafe QR are available through SpotSee and authorized SpotSee distribution channels.

Contact SpotSee to identify the temperature threshold and indicator configuration appropriate for your product and shipping application.