Timestrip Indicators Track Vaccine Cold Chain Specifications

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.

ultra low pharmaceutical storage

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.

adminTimestrip Indicators Track Vaccine Cold Chain Specifications
read more

White Paper: COVID-19 Vaccine & Antivirals – Delivering Solutions Safely

Timestrip has a new white paper detailing the importance of monitoring time and temperature parameters during storing and transporting to point of care

For more information on how Timestrip UK Ltd is handling the COVID-19 pandemic, please see this post.

adminWhite Paper: COVID-19 Vaccine & Antivirals – Delivering Solutions Safely
read more

Timestrip Blood Temp 10: less waste, lower cost, less risk

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
  • FDA approved
  • Ease of use
  • Lower costs
  • Less wastage
  • 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.

blood bags

During transit, whole blood needs to be kept within a temperature range of 2°C/36OF to 10°C/50°F. 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 preparation.

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.

blood temperature products

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 permanently changed.

FDA approved … and more

Timestrip® Blood Temp 10 has FDA certification (FDA 510(k) #BK190363) and is 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 compliance.

Cost savings

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.

The generation of similar positive temperature monitoring outcomes are possible using other products, such as electronic devices. These, however, are far costlier.

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 green

• 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

Product Specifications

10°C/50°F monitoring
Irreversible, single use
19mm x 32mm
Field activation
Visual proof of temperature exposure

Advantages over electronic dataloggers

Beyond 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.

The Timestrip® also is a super convenient shape: small, flat, with no batteries or any other electronic components to them.

For 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.

Lastly, 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 safety data.

With 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
read more

Time Out of Temperature Controlled Environment – TOTCE

Using a Chemical Time and Temperature Label

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.

Timestrip PLUS 10C 8hour

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.

temperature breach indicatorsTimestrip 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
read more

Operational Risk Assessment in the Logistics, Pharmaceutical & Food supply chains

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?

Firstly, let me say there will always be Risk not only in the common elements of the supply chain but also and especially with the way that you handle any cold chain or temperature-controlled products.

So how do you manage these risks?

There are 4 common and accepted ways that Risk can be managed, or mitigated:

  1. Risk Avoidance: Changes made to your processes and players that ensures risks are no longer an issue.
  2. Risk Mitigation: Reduce the severity of the loss or prevent the likelihood of the risk from occurring.
  3. Risk Acceptance: Avoidance of a potential risk area is not possible or economically feasible, so it is acceptable and will not impact your business.
  4. 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?

  1. Review and audit your supply chain to assess where risk does, or may exist
  2. Assess what the impact of these risks may be and create a list with the highest probability items at the top to address first
  3. Define your risk mitigation strategies for the highest-level items and work down the list from High to Low
  4. Implement the strategies and document them.

What else should I do, or know?

  1. Even though your Risk Management plan includes good SOP’s and WI’s make sure that people are adequately trained in these disciplines
  2. Conduct self-audits regularly
  3. The cost of a Cold Chain Monitoring device or solution, is far less expensive than the cost of disposal of a temperature compromised shipment
  4. All Quality Systems and Risk Aversion Plans should have one over-arching goal – Quality of Product and Consumer Safety!!!!

At Timestrip we are acutely aware of all kinds of risks that can exist in all kinds of supply chains from Pharmaceutical to Food and even beyond to special chemicals and laboratory testing time lines.

For a full range of our products please visit our products page

adminOperational Risk Assessment in the Logistics, Pharmaceutical & Food supply chains
read more