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Exclusive Timestrip Feature on That's West Anglia. Watch below:

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Transcript:

This little sticker plays an important part in measuring temperature breaches for seafood. The chemicals inside the indicator react to changes in temperature, irreversibly revealing any instances which might have impacted the quality of the product.

We supply into sectors like healthcare, blood, pharmaceutical, life science, and food which are all highly regulated sectors. These are regulated by the WHO, the FDA and other regulatory bodies globally.

At Timestrip, we have solutions that help the client adhere to those regulations and enable them to have confidence that their products are getting to the end location in the right status.

The technology can be adapted for a range of purposes.

We have time indicators that span 1 hour right up to 24 months and it's used as a visual impact reminder to do something. And that could be anything from replacing a water filter in your home or replacing the filter in your cooker hood.

But not only things in the home it's also used in the profession where healthcare professionals are reminded to renew or replace or change their antibacterial curtains. As well as replacements of cannulas, catheters, IV lines, and other applications like the prompt endoscope reprocessing which is a regulation and we help adhere to those regulations.

In healthcare the temperature indicators are used to ensure the safety of transported blood bags.

Regulations say if blood goes above 10°C through transportation it has to be discarded. Our indicators are proof it hasn't gone above 10°C if it hasn't and those blood bags can be put back in and reassigned to other patients.

Once the breach has happened they are non reversible. So once it has happened it can not be reversed or changed in anyway and this is one of the positive characteristics of the technology itself.

The sensors help eliminate waste and ensuring integrity of products. The company's new eTimestrip takes a step further towards data loggers.

Our eTimestrip is an indicator which can run for a long time because of being an electronic device. It is used for one or more temperature breaches. It has a traffic light system: red, green and amber to indicate to the user a temperature breach has occurred. And also it has the ability, by use of an app, to capture those breaches.

It captures the level of breach, the duration of breach, and also the time and date it occurred. This information is then uploaded to an application. the product itself is compliant to the 21CF Part 11D regulation which is very beneficial for pharmaceutical shipments, and highly valued and regulated product shipments.

With the press of a button the indicator gets to work. It may look simple, but this tiny piece of smart technology is as smart as it needs to be to carry out its mission. Science magazine, the Scientific American, named sensor technology as one of the emerging technologies for 2019, with potential to provide major benefits to society in the future.

Timestrip has won a mention in the ‘Top 10 Emerging Technologies of 2019’ by the prestigious magazine Scientific American.

The December edition analysed the emerging technology trends that are ‘poised to rattle the status quo’.

Timestrip was identified as one of the technologies with the potential to vastly improve food safety with its sensors to monitor the quality and safety of food.

Scientific American worked with the World Economic Forum to evaluate those trends that are attracting a lot of interest, and have the potential to provide major benefits to societies and economies. The selected few are expected to make significant inroads in the future.

Read the full list on the Scientific American site.

Timestrip ® – the innovative developer of ‘smart indicator’ technology – has launched a completely new category of product: Electronic Temperature Indicators

eTimestrip

The small, robust electronic Temperature Indicate and Report (TIR) devices. They provide a simple and reliable way to detect temperature breaches during product storage and transportation.

The compact electronic temperature breach indicators are affixed to product packages. eTimestrip clearly shows the temperature conditions during the entire supply chain, including the ‘last mile’.

Traffic light LEDs on the device show status information. Users can download the free smartphone app to retrieve data wirelessly.

A more detailed report can be generated and stored. This shows the date, time and extent of any temperature breaches that may have occurred.

By providing an auditable timed record of breaches, the electronic indicators open up a wide range of applications. They can monitor cost effectively throughout the supply chain.

eTimestrip will be used in pharmaceutical, healthcare, bulk food and other high value applications with temperature sensitive products.

eTimestrip indicators fit between traditional chemical indicators and expensive data loggers. The electronic temperature indicators provide a cost effective solution without complex software or special training to use.

The electronic temperature indicators

At launch, two products are available with a a measuring range of -30 °C to 70 °C:

eTimestrip TIR 2-8°C is designed principally for pharmaceuticals shipments.

eTimestrip TIR No Freeze 0°C is intended for use on products sensitive to freezing temperatures.

The addition of eTimestrip to our existing portfolio of temperature and time monitoring technology is part of our vision for Timestrip as a progressive, innovate business.

Our clients in a wide range of sectors look to Timestrip products to give peace of mind throughout the transportation and storage lifecycle of their goods.

Nora Murphy, Commercial Director of Timestrip

The new eTimestrip electronic temperature breach indicators are now available, and complement the company’s core product offering of stock, bespoke and custom branded indicators.

In December, Timestrip was identified in the ‘Top 10 Emerging Technologies of 2019’ by Scientific American magazine. The report analysed the technology trends that are ‘poised to rattle the status quo’, with the potential for sensors to vastly improve the safety and quality of food.

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 [su_list icon="icon: check" icon_color="#009cde"] Delivery of unambiguous safety data FDA approved Ease of use Lower costs Less wastage Low carbon footprint

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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/36^OF 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.

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:

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.

Timestrip will be attending the 29th Regional Congress of the International Society of Blood Transfusion (ISBT) in Basel, Switzerland from 22nd - 26th June 2019 We will demonstrate our Timestrip® Blood Temp 10 and Timestrip® Blood Temp 6 at the exhibition. We will be at Booth U106, Hall 4.U, please drop by and get a sample of our Blood Temp indicators to take away with you. Our Blood Temp irreversible blood bag temperature indicators monitor temperature compliance in blood bags. They are especially relevant for monitoring blood temperature during transit from the highly controlled environment of the blood bank to use or store in a different destination, such as a hospital. ISBT is a society in the field of blood transfusion, transplants, science and medicine. It facilitates knowledge about transfusion medicine to serve the interests of donors and patients.

Whether in a major teaching hospital, a walk-in clinic or a doctor’s surgery, any type of healthcare boils down to two broad objectives: improved patient outcomes and the best possible use of resources.

Although historically reconciling patient health and the harsh realities of budgetary constraints have at times led to difficult choices, the fact is that by integrating technology and innovation into decision making around resource allocation, both objectives can be achieved at the same time.

Indeed, thanks to its high tech / low cost Time and Temperature Indicator labels, Timestrip® is able to provide healthcare providers and the pharmaceutical sector with a broad range of practical, user-friendly solutions that:

✔ Ensure product quality

✔ Reduce product waste

✔ Ensure regulatory compliance

✔ Reduce time and temperature monitoring costs

But what does this look like in practice?

Improving quality control and efficiency

Tenet Healthcare is US healthcare provider that faced the challenge of needing to effectively manage how it processed bags of whole blood. On the one hand, it faced the need to comply with local regulatory requirements related to the use of effective temperature monitoring for blood products; and on the other, it had to discard any bag of blood that had been exposed to a temperature above 10°C for more than 30 minutes.

The company needed to be absolutely certain that any unused bag of whole blood was 100% safe to be returned to storage for future use. It had also noted ongoing difficulties in using other blood temperature indicators. Potentially, the latter could lead to doubts about product safety, which in turn would require that bag of blood to be discarded, possibly unnecessarily.

Its use of Timestrip® Blood Temp 10 – 10°C Blood Irreversible Transit Temperature Indicator noted the following advantages:

✔ Improved quality of care

✔ Improved workflow efficiency

✔ Maintenance of quality control during transportation and storage

✔ Support in complying with regulatory guidelines

Cost-effective regulatory compliance

Marathon Distributors is a pharmaceutical and healthcare logistics services provider in Cyprus and is involved in the distribution of pharmaceutical products throughout the island. The main cold chain management issue it faced was around compliance with local and EU regulations, specifically the country’s Law on Human Pharmaceuticals 70(I) 2001 and the EU guidelines on Good Distribution & Manufacturing Practices. These mandated the company to ensure that the pharmaceuticals it delivered were not exposed to a temperature above 8°C for more than 8 hours during transportation.

Although other products helped achieve regulatory compliance, the company began using Timestrip® PLUS™ 8°C 8 Hrs (TP065) Irreversible Time and Temperature Indicators because they were much more competitively priced.

Overall the company reported:

✔ Timestrip Indicators were 50% cheaper

✔ Delivery costs were 50% lower

✔ Delivery times were faster

✔ Positive end-user feedback around ease of use

Easy temperature monitoring for vaccine transport

Cambridgeshire Community Service NHS Trust is a UK healthcare provider in south-east England. Part of its work is the delivery of school-age immunisations to schools in its area. This includes for instance flu nasal immunisations for primary schools and HPV vaccinations and Meningitis ACWY and TdIPV for secondary schools.

For the delivery of vaccines, electric Labcold Portable Vaccine Carriers and pharmaceutical-grade vaccine carriers are used. In order to maintain the efficacy of the various transported vaccines, two different temperature ranges need to be managed: 2°C to 8°C and -25°C to 25°C.

In order to ensure the delivery of viable, unspoiled vaccines, the Trust thus had a requirement for a dual, low-cost solution for use by its delivery teams.

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To achieve this, two Timestrip products have been used in each vaccine carrier:

● a Timestrip® PLUS (TP 065) to indicate if the temperature went above 8°C

● a Timestrip® PLUS (TP 217) to indicate if the temperature exceeded 25°C, and if so, for how long

The feedback from the delivery teams has been extremely positive, specifically around:

✔ Easy to read visual data

✔ Ease of use

✔ Reliability

Reliable test kit time data

Clinical Innovations is a US maker of obstetrics devices that wanted to develop a non-invasive test kit for the diagnosis of any rupture of membranes (ROM). Although treatable, spontaneous ROM is a serious medical condition and a major cause of preterm births. Thus, an accurate diagnosis of ROM can be a key factor in determining timely and appropriate medical intervention. Similarly, a false diagnosis of ROM can lead to unnecessary hospitalisation, medication and even induced premature delivery.

Timestrip was able to provide Clinical Innovations with Time Indicators for its ROM Plus® self-contained test kit. These give clinicians the essential and immediate data they need to reduce the dangers of any premature ROM for expectant mothers and their babies.

The test kit uses Timestrip technology with an in-built 20-minute time monitoring indicator that generates the required data within 5-20 minutes, with 5,10 and 20 minutes clearly indicated on the Timestrip. Its key benefits are:

✔ Clear visual data

✔ Ease of use

✔ Improved health outcomes

Hygienic healthcare environment

Beyond pharmaceuticals and blood products, healthcare also involves various types of disposable items that need replacing regularly. Especially for the sick, hygiene in the clinical environment is an essential aspect of patients being able to make a full recovery.

Assuming the absence of any complications, catheters for instance need to be replaced every 30 days for Foley catheters and every 60-90 days for silicone catheters. Catheter bags however need to be replaced every 5-7 days. If these items are not replaced at appropriate intervals, opportunities are created for harmful pathogens to develop.

Unsurprisingly, this has also been shown to be the case for hospital privacy curtains. Dr Kevin Shek was the lead study author into the rate of contamination of hospital privacy curtains in a burns/plastic ward. In a report about the study findings in Nursing Times, he said:

“We know that privacy curtains pose a high risk for cross-contamination because they are frequently touched but infrequently changed. The high rate of contamination that we saw by the fourteenth day may represent an opportune time to intervene, either by cleaning or replacing the curtains."

Especially in busy hospital departments such as Accident & Emergency and ICU, hospital privacy curtains can quickly become contaminated with bacteria such as methicillin-resistant S. aureus (MRSA) and Clostridium difficile (C. diff). Thanks to Timestrip® Time Monitoring Indicator panels that change color after a set period of time, clinical staff are alerted when a privacy curtain needs to be changed. They help a hospital achieve:

✔ Best use of resources with a low-cost solution

✔ Compliance with guidelines around frequency of change

✔ Less time needed to monitor when that change needs to occur

✔ Hygienically clean hospital environment for patients

Wine has always been a popular drink and for many the fermented beverage of choice. In most cases whether you prefer Red or White, or even a Rose, experts and connoisseurs believe that any wine is best stored and served chilled.

So, you may well ask what is the difference between a wine served warm, or chilled, and does it really matter if the wine is warmer than expected, or even hot? Some wines are indeed served hot and are even used in cooking, but why is it important if it gets hotter than anticipated before it gets to the consumer?

Well, from an article in WinePair ™ a short time ago it was stated that; wines do change when they are subjected to a high temperature. Firstly, the tannins become 'more noticeable and wines take on a tangy, astringent character. Instead of a smooth and supple mouthfeel, wines feel rough and more one-note on the palate. Fruit flavors often become secondary to unpleasant acidity. In dry climates, corks shrink as they lose moisture, leading to leaky bottles and a sticky mess.'

This is all well and good, but at above what temperature would there be any noticeable change to the wine we drink?

Any wine should normally be stored between 55 – 65F (13-18C) and wine should be stored in a cellar, or a wine refrigerator, that maintains this recommended temperature level. And, it is generally noted that the change to the body of the wine begins at 70F (21C), and wines can “cook” as exposure temperatures hit 80F (26C) degrees and beyond. However, an occasional spike won’t decimate a wine, but prolonged exposure — like a week-long heat wave, or full day in the car — can.

So, what is an acceptable solution for making sure you can tell that a wine has breached its recommended storage temperature? – quite simply an Irreversible Time and Temperature Indicator label from Timestrip.

Timestrip offers a full range of stock labels including two that have a temperature breach of 20C and 25C (tolerance +/- 1C), and Timestrip can also produce a custom and branded label that can be set to monitor more specific temperature breach limits.

So, in the future be on the look out for some form of temperature indicator label on the bottle of wine that you buy to ensure that it has been kept at the recommended temperature to insure you get the most enjoyment from the wine that you buy and drink.

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. 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.

How Timestrip irreversible time sensitive indicators are used in Germany by Ulmer Wohnungs for their apartment ventilation units to remind tenants that they need to change the ventilation duct filters.

Translation: "In many UWS apartments, ventilation units are installed which permanently ensure fresh and clean air. Only when the filter is clean, do the fans work quietly and use less energy. In our video we show you how to easily change the filter."

Timestrip can make you a custom Time Sensitive Indicator Label - we create custom solutions that measure time ranging from 1 hour up to 2 years. We are ISO 9001:2015 certified and Timestrip time indicators offer a helpful visual reminder of service and maintenance schedules for consumable components. Accurate and reliable, Timestrips contribute to a more positive experience for the consumer and help ensure optimum performance from appliances that need replacement indicators or service reminder indicators in order to function effectively.

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