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.

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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

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Timestrip Complete: Q&A

What is Timestrip Complete?

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.

timestrip complete 2-8c monitoring

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.

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New Timestrip App: Digital Data Logger Performance at Analogue Prices

New Timestrip App: Digital Data Logger Performance at Analogue Prices

Time and Temperature Indicator maker Timestrip launches the Timestrip® Temperature app, a new tool that provides a visual audit trail of its temperature products.

Timestrip Android App
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Using the App simply involves taking a photo of a Timestrip® label with a smartphone.

If the Timestrip® has a new style serial number, the App will recognise the serial number and allow you to register it on the system.

You can then take a follow on scan where you can enter its activation state (inert, activated or breached), storing this data with essential time and location information in the cloud.

If the Timestrip® has an old style serial number you can still use the app in the same way but you’ll need to manually enter the serial number. The App is free to download from the Google Play store with an iOS version to follow shortly.

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High tech low cost

The App is the latest innovation from Timestrip, which revolutionised the field of cold chain management with its unique Irreversible Time and Temperature Indicator labels (TTIs).

Recognised by the World Health Organisation and the US FDA as an essential tool for the cold chain management of blood and food products, TTIs provide data as to whether a blood or food product is safe to use. Timestrip’s irreversible TTIs make this crucial safety information unambiguous and instantly visible.

Like having a hundred permanent digital data loggers

The main benefit of Timestrip’s irreversible TTI labels is that they give essential cold chain management information on individual units of processed products. This deals with the main shortcoming of digital data loggers, which are mostly used for containers of transported and stored products.

Thanks to the new Timestrip® App, extra key information around cold chain management is added with the safe storage of status, time, journey and location data, which can be accessed at any time via the app or via a website. A digital data logger can be lost or damaged and all its data can be wiped clean. The Timestrip® App however safely stores this data in the Cloud.

Data logger functionality at a fraction of the price

Timestrip UK CEO Reuben Isbitsky says: “I am very excited about our first App, which brings Timestrip TTI labels very close to data logger functionality, at a fraction of the price.  While a key benefit of Timestrip products is that they do not need external infrastructure to read and interpret, using the optional Timestrip Temperature App to scan them, adds enhanced functionality, easy audit trail and provides the customer with a permanent record of the history of the product’s journey.”

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Last Day of ISBT London 2015

The 25th Regional Congress of the ISBT London 2015 at the ExcEL Exhibition Centre is coming to a close and today is Timestrip’s last day exhibiting.

We have enjoyed the opportunity to show off our new 6°C blood temperature monitoring indicator, Blood Temp 6.

If you haven’t yet stopped by, take a moment to see a demonstration of Timestrip® Blood Temp 6 or Blood Temp 10 and pick up a sample to take home.

You can meet us and our range of blood temperature monitoring indicators at Booth 573 at the ISBT London 2015 exhibition.

ISBT London 2015

Our blood range indicators include both 6 and 10 degree ascending temperature indicators to extreme room temperature indicators.

Activated with simple finger pressure, Timestrip temperature indicators provide an easy to read indication of both activation and temperature breach.

BT10 blood temperature monitor 10C

 

 

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