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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.

Timestrip Plus activationHow 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.

Communication
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.

Can Timestrip Plus indicate if a temperature has fallen below a certain point?
Timestrip Plus™ can only show ascending temperature excursions. We have other products that do this type of descending temperature indication.
What is the shelf-life of Timestrip® PLUS?
Most Timestrip® PLUS products are provided with a shelf life of 2 years from shipping from our premises. Some formulations may be provided with a shelf-life of 2 years from date of manufacture. In all cases, an expiry date is provided for each batch of products supplied.
Any special storage requirements before activation?
No, unlike some other threshold temperature products, Timestrip® PLUS can be stored inert at ambient temperatures and only activated when needed.
Do I need to pre-condition indicators prior to activation?
No. Unlike some other threshold temperature products, Timestrip® PLUS does not require pre-conditioning. You need to activate above the product’s threshold temperature, as you cannot squeeze the dye out of the blister if it is in solid form. Immediately after activation, stop the progress of the dye by placing the indicator below its STOP temperature. You can adhere the Timestrip immediately to a product or carrying card which is below the STOP temperature. Alternatively place the activated indicator in an environment much colder than the STOP temperature for a short period of time.
Why do Timestrip® PLUS have a ‘START’ and a ‘STOP’ threshold temperature ?
The melting point of a solid is the temperature at which it changes state from solid to liquid. The freezing point (or crystallization point) is the temperature at which a liquid changes to a solid. For certain substances the melting and freezing point are not the same and the freezing point is lower than the melt point. This behaviour is called hysteresis. At the STOP point (freezing point) the dye can’t move. At the melt point the dye moves and indicates a threshold breach.
How does Timestrip® PLUS work?
A blue dye housed in a blister is held adjacent to a micro-porous membrane. Upon squeezing the activation button the liquid dye comes out of the blister and into contact with the membrane. If the temperature of the product is below the stated ‘STOP’ temperature, the  blue dye changes state to solid form, and it is unable to move through the membrane. If the temperature rises to or above the threshold temperature, the dye changes to liquid form and moves at a precise rate through the membrane. Its progress is irreversible and the distance it travels through the viewing window indicates the cumulative time the indicator has been exposed to the threshold temperature or above.  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.
What is Timestrip® PLUS?
It is a single use temperature indicator in a self-adhesive label format. It indicates if temperature has risen to breach a defined threshold and it records the cumulative elapsed time of all such breaches. Each product in the range is engineered to respond to a different threshold temperature so customers can choose the product that best suits their needs.
How can I use Timestrip® PLUS?
They are suitable for many situations when elevated temperatures can create problems for a product. Common applications are frozen or chilled foods, medicines, vaccines, adhesives and chemicals. A common use is to identify the elapsed time of temperature abuse during shipping. Another is for products which are taken repeatedly in and out of their ideal storage conditions for temporary use, like lab chemicals. One or two excursions might not be problematic, but Timestrip® PLUS shows the cumulative time of all excursions and this can be used to trigger a timely replacement of the product.
What are your Acceptable Quality Limits?
The Accepted Failure Rate is based on ANSI/ASQC Z1.4 (formally MIL-STD-105E) Level II Normal Inspection.  For Timestrip® PLUS the AQL is 0.65%.  Packs are over shipped by 2-3 units per 100 to cover this AQL. Timestrip® PLUS indicators go through extensive quality checks before they are shipped. Central to this process are tests against defined specifications for; run-time accuracy (how quickly the dye progresses through the membrane), environment sensitivity (high heat and vacuum tests to check resilience to harsh conditions during shipping) and also the accuracy of the threshold melting point.  A full pack of release reports is provided with each shipment.  Further details are available on request.
What if one of the indicators in my pack has got a blue activation window or there is blue in the run-out window, before I’ve pressed the activation button?
If stored under the correct conditions, there is very little risk of auto-activation, but occasionally, this can happen, and the built-in activation window lets you know it. If an indicator has auto-activated before use the activation window will already be showing blue and ON.  The blue liquid may also be showing against the time-markers in the run-out window.  If this happens, discard the indicator and select another.  There is no need to contact us, as we ship a few extra units per hundred anyway.
Can I get a false positive indication?
If the indicator is correctly activated false positives are extremely unlikely as the blue dye can only melt at or above certain temperatures.  It is important to lower the indicator to its STOP temperature after activation and only attach it to a product, carrying card or material that is already at or below the STOP temperature to avoid premature indication.
Can you customize Timestrip® PLUS?
For a minimum order value of 50,000 units we can make a customised Timestrip ® PLUS. There is a set up and per unit premium for this service dependent on the specifications required.  Graphic customisation can include changing the scale on the run-out window to different time markers and using customer logos and colours.  It can also include hiding the progress of the blue dye so the end user just sees when a maximum elapsed time of temperature abuse has been reached.

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