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New Run Out Times

48 Hour now available in 8°C & 10°C

Timestrip Plus 8°C Irreversible Temperature Indicator

Rules & Regulations of the State of Georgia for Compounding & Mail Order Pharmacies

Rule 480-48-.02 (3) regarding temperature and mail order regulations

Conditions for Use of Delivery by Mail

A mail order pharmacy shall ensure that all prescription drug order medications are delivered to the patient in accordance with standards of the drug manufacturer’s temperature standards as set by the Food and Drug Administration (FDA). Pharmacy shall insure integrity of any drug requiring temperature control other than “room temperature storage” that is delivered by mail order by enclosing in each medication’s packaging a USP-recognized method by which the patient can easily detect improper storage or temperature variations.

How long did a temperature breach last? It’s great to have a product that tells you if a temperature breach has occurred, but sometimes you need more information – like how long did the breach last? For some products, this is the vital detail and Timestrip® PLUS provides it.

Timestrip® PLUS will tell you how long a product has been exposed to higher temperatures and is the first truly cost-effective indicator to do so.

Once activated, Timestrip® PLUS will keep monitoring temperature for days, weeks or months, depending on your needs. During that time it will record how long any temperature breaches last.

Here is an example. An 8°C Timestrip® PLUS was chosen to monitor a shipment which would take 3 weeks to arrive. When the shipment arrived, the indicator showed 4 hours of 8°C breach. This breach could have happened in one long event or from a series of shorter breach events across the 3 weeks. The 8°C Timestrip® PLUS could have indicated up to 8 hours of temperature breaches during that 3 weeks.

image_8C BOT TSP-065-02-02Timestrip PLUS 065
for Fridge, Pharma Shipments
8°C / 46°F
8 Hour run-out window
Timestrip PLUS 8C 48hours BOB-TP175Timestrip PLUS 175
for Fridge, Pharma Shipments
8°C / 46°F
48 Hour run-out window
Activation feature – can be shipped and stored under any temperature conditions, saving money and hassle
Highly Accurate
Indicator window confirms activation, to let you know the product is ‘on’
Unique serial code printed on each indicator for traceability
Long shelf life
Unambiguous color progression to show length of temperature breach
Product can be delivered by the piece or in rolls
Customized product & carrying cards available to distinguish your company or your customer
Water Resistant
Modern Look & Feel
Environmentally friendly

Available for a wide variety of temperatures Timestrip® PLUS indicators are accurate, cost-effective and easy to use and can be directly applied to products and/or packaging. Timestrip® PLUS indicators are available for a variety of temperature thresholds ranging from -20°C to +30°C.  Custom temperatures can be produced subject to minimum order quantities.

Are they waterproof?
Timestrips® are not designed to be submerged in water, but they are very splash-proof and can be immersed in water for short periods without any effect.
Is the liquid safe?
Yes.  Please see the product MSDS on our website for further information. We only use food-grade oils and non-toxic colourants in our formulation. In the unlikely event that the liquid leaks from the indicator and comes into contact with skin, simply wash with soap and water. If the liquid comes into contact with eyes, rinse immediately with plenty of water and seek medical advice.
Can Timestrips be used in any direction / orientation?
Yes.  Orientation has no impact on the way it works.
How are Timestrip® PLUS products evaluated for their time accuracy?
Timestrip®  PLUS are polymeric multi-layer indicators. They are based on spontaneous lateral wetting by a blue liquid inside a porous substrate and not a chemical reaction. Each production batch (7000 – 8000 products) undergoes strict quality control tests to validate its time accuracy. This is conducted via a computer vision software (TSCV) which analyses scanned photos of seven randomly-selected products from each batch (roughly 0.1% of the population). The photos are taken at different elapsed times and the tested products are placed at their designated temperature through the entire test period. The software automatically analyses the lateral progress and the elapsed time of each product tested and the data is presented numerically and graphically in a specific file which is labelled by batch.  This data is translated into a final release report which is attached to the outgoing product batches.  
What happens at elevated temperatures?
Due to the nature of liquids, higher temperatures reduce the viscosity of the liquid dye in Timestrip® PLUS. The correlated result is faster/shorter run-times (the progressing blue dye will reach each printed time-mark sooner than intended). So, if an 8°C/46°F indicator is exposed to 25°C/77°F for a consistent period then the blue dye will progress more quickly through the membrane than if it was exposed to 10°C/50°F for a consistent period. Timestrip Plus 10C GraphThis graph shows the run-time acceleration of a 10°C/50°F Timestrip PLUS at different elevated temperatures. The y-axis represents the actual run-time of the liquid dye at different temperatures, and is expressed as a percentage of the specified run-out time at an isotherm of 12°C/54°F. So, at an isothermal temperature of 12°C, the liquid dye will reach each time-marker (1, 2, 4, 8, hours etc) within these times +/-15% in time. However, if for example the product is exposed to an isotherm of 21°C/70°F the dye will reach each time marker within only 77% of the intended run-time. In other words, it will reach the;
  • 1 hour time-marker within approximately 46 minutes (77% of 1 hour)
  • 2 hour time-marker within approximately 1.32 hours and so on.
At a less extreme temperature elevation, say 15°C/59°F the blue dye will reach each time-marker at 91% of the intended time.
Why is there an activation window and a runout window?
The activation window gives confidence that the product is armed. The breach/run-out window is separate so that it clearly indicates a breach of the temperature threshold and the cumulative elapsed time of the breach.
What is the maximum run-time Timestrip® PLUS range can offer?
The maximum run-time varies between hours to days dependent on the product and its application. Note that the run-time is only referring to the time above its breach temperature.  Timestrip® PLUS can remain active and vigilant for long periods of time (up to a year after activated) if the run out window has not completely filled in.
What is the accuracy of the hour marks?
Every Timestrip Plus™ product is calibrated to a temperature of 2˚C above its stated threshold temperature. For example, Timestrip Plus™ 12˚C is calibrated to a temperature of 14˚C. When the product breaches its threshold temperature and is held at a constant temperature(i.e. isotherm) of 14˚ C, it will reach the 1 Hour print mark within 1 Hr (+/- 15% in time).
Timestrip® PLUS compare with data loggers?
There are fundamental differences. Data loggers are expensive and typically are designed to go on large shipments. They are not an immediate tool as they need to be returned/connected for the data to be read and acted on, and they have to be used repeatedly to justify the expense. They also require power. Timestrip® PLUS indicators are less expensive, require no power, are single use and can be instantly read by the end user. They have unique serial numbersto ensure the traceability of each indicator to avoid the potential for manipulation across the distribution chain. As well as being effective for large shipments, Timestrip® PLUS are small light and cost effective enough to be used at the carton or single unit level. Using them at multiple points within a shipment or container can isolate unacceptable temperature pockets. Data loggers provide a full history of temperature from the time of activation. Timestrip® PLUS records how long a product has been above its threshold temperature (up to the maximum printed on the scale - usually 8 or 12 cumulative hours) but cannot tell you when the breach or breaches occurred. Timestrip® PLUS is most often used to monitor and validate the “last-mile” of a cold chain or other temperature environment, in other words, when the product is close to its eventual use. In some cases data loggers and Timestrip® PLUS indicators may be used in complementary ways to help monitor temperatures.
Can you customize for us?
We have a growing range of standard products that meet most cold chain requirements. As a general rule, if you require more than 50,000 units, we can customize the print, and in many cases, even the melt temperature, although we have an extensive existing range. There is a premium for this service. We can also quote on custom carrier cards and backing labels, if you need to provide instructions, add other languages, or a form to provide a permanent record.
What can they be used on?
Anything where elevated temperatures are an issue. Common applications are frozen or chilled foods, medicines, vaccines, blood products and adhesives.
How accurate are Timestrip® PLUS?
+/- 1 ̊C for the temperature component and 15% for the time component under isothermal conditions. The progress of the blue dye across the time-markers is calibrated to a temperature of 2 ̊C above the stated threshold temperature. For example, the time markers for Timestrip® PLUS 12 ̊C are calibrated to a temperature of 14 ̊C. When the product breaches its threshold temperature and is held at a constant temperature of 14 ̊C (i.e. isotherm), the blue liquid will reach the 1 hour print mark within 1 hour (+/- 15% in time). If the breach is at a much higher temperature than the stated threshold temperature, the indicator dye becomes thinner and will run faster.

Our products are manufactured under the controls established by an IQC approved quality management system that conforms with ISO 9001:2008