An FDA-approved Irreversible Time and Temperature Indicator that ensures that only viable whole blood supplies are used post-transit
The high tech, low cost alternative to electronic dataloggers
Delivery of unambiguous safety data
Ease of use
Low carbon footprint
critical issue for medical professionals is ensuring the viability of blood
supplies once they leave the highly controlled storage environment, such as a
blood bank refrigerator or
a hospital blood storage facility. This aspect of the so-called blood
cold chain is essential for ensuring that these are kept at the correct
temperature right up to the time they are administered by trauma units,
ERs, operating theatre staff, air/ ground ambulances, and any other situation
requiring blood to be transported from storage units out to patients.
During transit, whole blood needs to be
kept within a temperature range of 2°C/36OF
Below this range, there is a risk of freezing with the formation of ice
crystals, rendering the blood unusable, while upper temperature breaches create
the possibility of blood being affected by an overgrowth of non-specific
bacteria, which may have entered the blood unit during collection or component
Both these situations have serious
consequences: the cost implications of a wasted product and/or more seriously,
a patient that is put at risk.
To address these issues, Timestrip® has
developed its single-use Blood Temp 10 – a high-tech, low cost Irreversible
Time & Temperature Indicator that effectively monitors temperature breaches
above 10°C/50°F during transit.
No more guesswork
Thanks to its innovative technology,
Timestrip® Blood Temp 10 removes this uncertainty by providing clear,
unambiguous data as to whether a supply of whole blood is safe to use or be
returned to storage.
This is achieved thanks to the smart
label’s two indicator windows:
• the first window to indicate if the
label has been activated
• the second to indicate if a temperature
breach has occurred
Thus, at a glance, medical staff know if
a supply of whole blood is not only safe to use post-transit. The smart label
also ensures a higher level of quality of the product is delivered by
monitoring of temperature throughout transit.
Moreover, thanks to its irreversible feature,
once the smart label has reacted to a temperature breach, this cannot be
undone. For security reasons, the colour of the label’s indicator window stays
FDA approved … and more
Timestrip® Blood Temp 10 has FDA
certification (FDA 510(k) #BK190363)
manufactured with controls established by a IQC approved quality management system that
conforms with ISO 9001:2015 and ISO 13485:2016.
With a temperature accuracy of +/- 0.5°C,
this means that the Timestrip® label is designed with reliable and, more
importantly, trustworthy technology as assessed by some of the world’s most
stringent criteria. Moreover, extra security is assured by every Timestrip®
label having its own unique serial number, thus ensuring full traceability.
Checking this list of features brings
further benefits to healthcare providers involved in the transportation of
whole blood by also ticking the box for local and internal regulatory
Because Timestrip® Blood Temp 10 ensures
that only viable blood supplies are either administered post-transit, or
returned to storage, the possibility of precautionary disposal is eliminated.
This reduction in waste can have significant cost benefits.
In fact, studies
have shown that loss rates without a Timestrip® are around 5%. These are halved with its use. In fact,
reducing a loss rate by 9.9% pays for the total investment and a conservative
19.8% reduction doubles the ROI.
generation of similar positive temperature monitoring outcomes are possible
using other products, such as electronic devices. These, however, are far
Ease of use
Apart from delivering clear, unambiguous data as to
whether post-transit a unit of whole blood may be used or returned to storage
thanks its innovative indicator windows, the Timestrip® Blood Temp 10 is also
remarkably easy to use.
In fact, unlike other whole blood temperature
monitoring solutions on the market, Timestrip® Blood Temp 10 is a unique FDA
510(k) medical device that does not require preconditioning. Moreover, it is
also CE approved and designed for:
• quick and easy application
• no prior conditioning by blood storage staff
• temperature breach data delivered at a glance by
medical field personnel.
Prior to the transit of a unit of whole blood, a
simple squeeze of the label’s activation blister is all that is required for
temperature monitoring of a unit of whole blood to begin. Then the label just
needs to stuck on the unit.
Squeeze, peel and stick – that’s it!
And the end of transit, Timestrip® technology has
also been designed for maximum ease of use:
• until activation, the first indicator window is
yellow and the second is white
• upon activation, the first indicator window turns
• if a temperature breach has occurred during transit, the duration of the breach is indicated by the second white indicator window that proportionately fills up with blue dye
Irreversible, single use
19mm x 32mm
Visual proof of temperature exposure
Advantages over electronic dataloggers
being less expensive, Timestrip® Blood Temp 10 does not involve a datalogger’s
complicated and sometimes cumbersome unit return program that is necessary to
make it more affordable. The smart label’s single use indicator makes it the
ideal fit for simple, straightforward and effective temperature monitoring.
Timestrip® also is a super convenient shape: small, flat, with no batteries or
any other electronic components to them.
green credentials, the Timestrip® also outstrips traditional dataloggers in
terms of carbon footprint, because the latter eventually needs to be either be
thrown away or sent back to source to justify the expenditure.
the Timestrip® has the potential of generating more accurate safety data.
Indeed, because a container of units of whole blood will tend to use just a
single datalogger, inevitably the temperature of ambient air within the
container is taken into account, potentially generating less than accurate
Timestrip® labels however, every single unit has its own temperature indicator.
This means that the possibility of rejecting an entire shipment based on a
single result is eliminated.
adminTimestrip Blood Temp 10: less waste, lower cost, less risk
There are many ways to measure temperature change and for recording how long a temperature-controlled substance, material, or chemical compound, is maintained outside of its normal required temperature limits for stability, or future use. Time Out is not a new term, or monitoring application, but it is a complex one and certainly needed. The most common is for Pre-Preg and Carbon Fiber materials that must be maintained within strict temperature guidelines for flexibility and strength requirements, plus many Chemical compounds and liquid API’s (Active Pharmaceutical Ingredients). These strict limits also apply to certain bio-logics and vaccines that can only be “out-of-environment” for short periods of time whilst they are being worked with, formulated, or packaged.
These tracking solutions range from RFID tracking and monitoring with expensive tags and readers to complex solution software applications that read and record these expensive electronic devices, attached to the item being monitored, as these pass in and out of the safe temperature zones.
On the low-end monitoring is done by timers with alarms and some form of temperature recorder to show the temperature limits that the materials were exposed to. Combine both elements and you get a Time and Temperature limit that the materials were within showing how long this was for.
But in some applications, simplicity may be a better solution like – a time and temperature breach indicator label, instead of reading separate items and manually recording these for record purposes.
Timestrip Plus labels and Run Timer Labels are used for many applications ranging from monitoring event times related to an expiration of effect use life to monitoring vaccine and bio’ shipments as these pass through a logistics operation, or down the cold chain supply chain. However, if you take a Timestrip Plus label that contains a time element and a temperature limit indicator for an excursion, or the work environment temperature, you have a truly unique and simple way of measuring TOTCE!
The advantage that these labels offer is quite simple by the fact that once the label is outside of its “strike” temperature the chemical will flow down the time indicator scale to show how long the label is outside of the lower product stability-controlled temperature environment. When the material or chemical substance with the label attached is returned to the temperature-controlled environment the chemical will stop flowing and only now show the “Out-Time”. If this item is taken in and out many times the label will begin to form a total aggregated TOTCE as the chemical flows and stops each time it moves in and out of the two environments.
A record of each individual “Out-Time” can be captured by taking a photo with a Smart Phone which will show the time and date that it was taken, and this can be stored as a permanent record linked to the serial number on the label itself that will be clearly seen in the photograph.
Sometimes simple is the best approach based upon the old adage of the “KISS” philosophy, so contact Timestrip today if you want to find out more about this TOTCE solution offering.
adminTime Out of Temperature Controlled Environment – TOTCE
The big word in the logistics and supply chain “world” is RISK, and a risk assessment being performed, or at least having a mitigation plan in place, is becoming part of many certification requirements, like ISO 9001, and other pending or recently introduced federal regulations.
It will be no surprise, I am sure, when I mention certain facts like – “Where humans are involved in a process there will be errors, and 90% plus of all supply chain errors are human errors”; but how do you avoid these?
There are 4 common and accepted ways that Risk can be managed, or mitigated:
Risk Avoidance: Changes made to your processes and players that ensures risks are no longer an issue.
Risk Mitigation: Reduce the severity of the loss or prevent the likelihood of the risk from occurring.
Risk Acceptance: Avoidance of a potential risk area is not possible or economically feasible, so it is acceptable and will not impact your business.
Risk Deflection: After the risk has been identified and quantified, transfer that risk to the control of another player or partner in the process – maybe add it as a clause to be addressed in a vendor contract.
So how do you establish a Risk Mitigation Plan?
Review and audit your supply chain to assess where risk does, or may exist
Assess what the impact of these risks may be and create a list with the highest probability items at the top to address first
Define your risk mitigation strategies for the highest-level items and work down the list from High to Low
Implement the strategies and document them.
What else should I do, or know?
Even though your Risk Management plan includes good SOP’s and WI’s make sure that people are adequately trained in these disciplines
Timestrip Complete is our product that monitors upper and lower threshold temperature breaches, such as 2°-8°C cold chain monitoring for vaccine storage and transport.
The product is in fact made up of two elements: a Timestrip Plus, which is our ascending indicator that measures, for example temperature breaches above 8°C and the amount of time that they have breached, and a descending temperature indicator called Freeze Check Plus FCP for short that logs breaches, for example, below 2°C.
This is why we’ve called the indicator “Timestrip Complete”: It provides complete monitoring for the 2°-8°C cold chain.
Why was Timestrip Complete developed for vaccine storage and transport?
A vaccine is affected by heat and by freezing and the two critical temperature thresholds for storage and transport are 2°C and 8°C.
It’s time and temperature that’s the critical factor leading to degradation of vaccines.
For freezing, the crucial event is whether this has happened or not. Because vaccines are contained in an aqueous solution (water), when it freezes, it expands and the resulting crystallization can destroy the vaccine
How much does a Timestrip Complete cost?
Under US $4 per unit, and considerably less in volume purchase. It’s the lowest cost solution and easiest to implement to achieve complete 2°C-8°C temperature monitoring. Any other tool that does this job involves using a single-use digital data logger, which start at about US$10 per unit
This totally fits in with our company ethos of providing the easiest, simplest and most cost-effective products for temperature monitoring. Many 0°C or 2°C descending indicator on their own for instance normally costs at least US$2.50, so we know that our sub-US $4 price is very competitive.
How do you use Timestrip Complete?
It can be stored at room temperature, is inert until activated and has a button-like feature that needs to be pushed for activation.
There is an extra measure needed in storage to bear in mind— and this is industry-wide for all descending temperature indicators — is that they are always active.
This means they need to ship to end-users above the temperature they monitor and we achieve this by packing them with heat packs to ensure they never go below 2°C.
On the positive side from our clients point of view, because the ascending indicator can be stored at room temperature, they only need to ensure that our products are kept above freezing.
Similar products present the logistic difficulties of needing to be kept above 2°C and below 8°C, so this is a big advantage
Are there other Timestrip Complete products apart from 2°C-8°C?
Yes, this is a key range which we are looking to grow. The product also comes as 0°C-8°C
Timestrip Complete 0°C – 8°C and 2°C – 8°C are also used for the storage and transportation of medicine and biologics.
We are now launching a Controlled Room Temperature indicator that has 15°C and 25°C thresholds. These are designed for environments such as food transportation for airlines.
The key message here though is that we have the technology to produce a variety of complete upper and lower level temperature monitoring — and at a very competitive price.
What’s been the feedback so far from end-users of these complete temperature monitoring indicators?
Timestrip was involved in supporting anti-rabies work in Malawi with a 0°C-30°C indicator for the transportation and storage of canine vaccine. Rabies is huge problem in Malawi and spoilt vaccines seriously hamper efforts to address the situation.
The bottom line was that this 0°C-30°C product was successful in identifying those doses of canine vaccine that were either spoilt because of ambient heat exposure or from freezing caused by the ice-packs that are used during transportation.
This allowed for a re-stocking with unspoilt vaccines that ensured that the anti-rabies field teams’ efforts were effective and thereby measurably supported the prevention of more cases of rabies in Malawi.
Marathon Distributors is a pharmaceutical and healthcare logistics services provider on the island of Cyprus. With an annual turnover of over $40m, it has a 35-38% market share for its range of activities and employs a workforce of just over 40 people.
Its services include warehousing, transportation and distribution and it boasts a state-of-the-art warehouse strategically located on the outskirts of Nicosia (Latsia Industrial Area), just-off the Nicosia-Limassol-Larnaca highway. The warehouse area has a floor space of 2,500m2 and a modern cold storage area with a capacity of 70m3.
For transportation, it operates its own fleet of 18 vehicles — all temperature controlled and GPS monitored — and they cover 100% of the island. The vehicles deliver to pharmacies, pharmacy depots, physicians, hospitals, clinics and clinical laboratories across the island.
Cold chain issues fall under the remit of MD Simone Kapakiotis. Her work covers all aspects for the warehousing and transportation of cold chain products, which are mainly vaccines.
The main regulations that the company needs to comply with are the Law on Human Pharmaceuticals 70(I) 2001 and EU guidelines on Good Distribution & Manufacturing Practices.
The company faces numerous challenges in the sectors it operates in. Firstly, the Cyprus market is of a relatively small size, which stifles its potential for growth. Also, it is a highly regulated environment, subject to numerous stringent EU guidelines. Lastly, the business itself must manage quite high operating costs and low profit margins.
On the plus side however, due to relatively short transportation distances on the island (delivery times are 6 hours at most) and the company’s use of validated cooling containers for the transportation of cold chain products, it never generates any product waste.
Use of Timestrip Indicators
Because of its environment, Marathon uses Timestrip Plus 8°C 8 Hrs (TP065), which monitor temperature breaches above 8°C for periods of up to eight hours. Cold chain issues are of concern during the transportation process.
The procedure followed for using Timestrips is that they are placed in all orders containing cold chain products. These indicate to drivers and customers whether a temperature deviation has occurred during transportation. If no deviation occurs, customers receive orders and sign all the relevant documentation. If however a deviation has taken place, these orders are returned to the warehouse and the company sets in motion a deviation procedure that needs to be followed.
The Timestrip Solution
The main reasons the company uses Timestrip TTIs above other approved TTIs are a competitive price, the reliability of the product, an easy order system and speed of delivery.
Significant improvement has been noted in these areas since the company began to use Timestrips. The product itself is 50% cheaper than other similar products. Also, delivery times are one day faster and delivery costs are 50% lower than before. Other Benefits
Feedback from Marathon’s customers has been very positive and have enhanced its standing with them. They particularly like that Timestrips are easy to use, easy to read and reliable.
Simone Kapakiotis says: “The use of Timestrips adds to our company’s reputation of being professional and reliable.”
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