Timestrip®, the developer of smart indicator technology, has released two new ranges designed to be used with the latest coronavirus vaccines now becoming available. The indicators track temperature and time, and will ensure that vaccines are fresh when administered to patients.
The Timestrip Vaccine Thaw Timer is an event thaw indicator with 24 hour time indication calibrated to run at fridge temperatures. It can be packed with vaccines that require storage at -70°C in the ultra-cold chain, and automatically starts monitoring as the vaccine is thawed and transferred to chilled conditions at the hospital or surgery. It then tracks the time from thaw at 6 hours, 12 hours and up to 24 hours, meeting the specifications for use from manufacturers such as Pfizer.
The Timestrip Vaccine Refrigeration Monitor range comprises three indicators. One is designed to indicate the thawing event of the vaccine; another will time 30 days duration in refrigerator conditions (2°C-8°C), helping the user to manage the vaccine manufacturer’s guidelines for use.
Then, when the vaccine has been taken from the refrigerator and prepared for use, a third indicator monitors how long it has been exposed to temperatures above 8°C, typically at room temperature. The time ‘run out’ for the Vaccine Refrigeration Monitor VOR12 (Vaccine Out of Refrigerator) is up to 12 hours, with shorter times to an alert being seen at higher temperatures.
These Vaccine Refrigeration Monitor products will help overcome challenges in the handling of COVID-19 vaccines up to the point of administering, and are designed to support the manufacturers’ specification for the handling of vaccines such as those from Moderna.
Both indicators provide a clear irreversible indication to healthcare staff that conditions of storage and handling have exceeded acceptable conditions, and that the vaccine consignment cannot be relied upon.
Based on safe chemical technology, both the Vaccine Thaw Timer and Vaccine Refrigeration Monitor range overcome the limitations of batteries used at ultra-low temperatures.
We continue to innovate our patented technology to bring the benefits to important applications such as vaccine distribution, supply and last mile handling. Using these indicators, healthcare professionals worldwide can be supported cost effectively, and guided through soon to be routine practices of handling and managing these vital resources.
Nora Murphy, Commercial Director of Timestrip.
Timestrip has recently added other products to its range in response to coronavirus. These include an indicator to monitor antiviral solutions, and Rapid Diagnostics 15, a 15 minute timer indicator for use with rapid turnaround lateral flow test kits.
These indicators monitor when specimens – including coronavirus – have been stored for too long and outside the required temperature range for reliable testing.
Four products make up the VST range.
Together they form an essential tool to support hospitals, surgeries and medical laboratories in storing and transporting virus specimens correctly, and preserving their integrity.
A virus specimen’s exposure to temperature over time is critical to its lifetime, so the VST series includes a unique integrating indicator, the Timestrip VST TTI, which mirrors the accumulated time-temperature history of the virus specimen during transport and storage.
Virology specimen collection guidelines state that most viruses remain stable at 4°C for 2-3 days, so VST TTI is effective with a wide range of virus types.
Designed to meet specific regulations, the TTI label will indicate when 72 hours of chilled storage has elapsed by showing a clear visual discard window. At high temperatures, the label will show the discard indication within just a few hours.
Scientists and clinicians know that bacteria and viruses deteriorate much more quickly as temperatures increase, and also as exposure time increases. For example, at 50-55°C, coronavirus becomes non-infectious within just a few hours.
FDA and WHO regulations state that it is important to avoid freezing and thawing of specimens.
The Timestrip VST 0°Cwill reliably track a thawing event. If the ambient temperature rises above freezing, the indicator will show the cumulative period of thawing.
Timestrip VST Fridge Combi includes two indicators. One unique element indicates when a period of 72 hours has passed during chilled conditions (2-8°C), aligning with FDA / WHO regulations.
The other element provides a temperature breach indication, giving a clear signal when conditions have exceeded the regulated upper chilled limit of 8°C/46°F during storage or transport.
“As part of the fight against coronavirus, our new VST virus specimen transport range will help support scientists by monitoring specimens from collection right through to point of test, giving confidence in the integrity of the specimen, and thus the test results.
These simple yet effective products provide a solution to a real problem in the storage and handling of virus specimens, including Covid-19. Medics and laboratory technicians can now have an explicit signal when specimens have breached the safe zone of thermal exposure and are invalid for testing.”
Nora Murphy, Commercial Director of Timestrip UK Ltd
The VST is expected to be the first of many speciality ranges to be offered by Timestrip that provide practical solutions for pathology, microbiology, mycobacteria and other laboratory specimen handling, where temperature and time monitoring are required.
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
A 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.
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
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
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