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.

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

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.

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.

Company Profile & Environment

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.”

Abstract: The World Health Organisation stresses the importance of maintaining the cold chain for temperature sensitive vaccines. Due to the recommendation for rabies vaccines to be stored between 2° and 8° Celsius and the nature of canine mass vaccination projects, cold chain maintenance remains one of the most significant logistical hurdles project managers have to overcome.

Mission Rabies field teams in Malawi evaluated the use of adhesive temperature monitors as an alternative to thermometers in both storage fridges and field cooler boxes during the duration of a 4 week mass vaccination drive in April/May 2016.

Two different Timestrip® temperature monitors were used to alert the teams to the critical temperature thresholds of 0°C and 30°C.  As freezing rapidly damages vaccines, each vaccine box containing 10 vials of 10ml vaccine was marked with a monitor that indicates the immediate crossing of the lower threshold through colour change. As damage from high temperatures is related to both the temperature achieved and the time of exposure, to test for the upper temperature limit each cooler box was equipped with a monitor that showed the crossing of the upper threshold over time.

Of a total of 22 vaccination teams participating in the study, 7 teams reported an exposure of the vaccines to temperatures above 30°C for more than 4 hours and on 9 occasions teams reported a temperature drop to 0°C or below.

These findings highlight the importance of monitoring the temperature during field campaigns, both due to proximity to ice packs and exposure to high outside temperatures. The use of Timestrip temperature indicators gives early visual clues and raises awareness among the team. However practicability of the temperature monitoring must be taken into consideration and adhesive monitors need to be improved with regards to their setup to make them a valuable tool in field projects.

This abstract was presented at the 28th Annual Rabies in The Americas Conference on 23 October 2017.

Authors: Frederic Lohr, Reuben Isbitsky, Andy Gibson, Alasdair King

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

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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.

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."

Timestrip UK Ltd have expanded their range to include their latest Timestrip PLUS™ 10°C threshold indicator with a 7-day run-out/recording window. This specific indicator is meeting the demand within the pharmaceutical industry and the regulations and compliance that come with transportation and storage. With Timestrip’s latest 10° 7 day offering, they are reaching out further within the Pharmaceutical and Healthcare industry and ensuring their high tech but low cost devices are evolving with the relevant advances in the industries.

7 Day Pharmaceutical temperature breach indicator

Timestrip design and manufacture innovative, irreversible time and temperature indicators for a range of industries from Food to Pharmaceutical. Their Timestrip® PLUS range is predominantly used across the Healthcare, Life sciences and Pharmaceutical arena. Currently, the Timestrip PLUS™ range covers temperature thresholds from -20°C up to 38°C and generally display a run-out window of any temperature breach for 8, 12 or 48 hours.

Combining time & temperature monitoring patented technology, which involves controlled rate lateral diffusion of liquids through the device membrane once activated. If a breach occurs, the ‘smart’ indicators will visually indicate how long a product has been exposed to higher temperatures.

For a free sample of the new 10° 7 day indicator, or to place an order click here

Timestrip UK Ltd has announced it is working with Trust for Vaccines & Immunization (TVI), a not-for-profit organization, established to help ensure that every child, irrespective of his/her social class, colour or ethnic group is protected against Vaccine Preventable Diseases in Pakistan and around the world.

TVI is the recipient of a Bill & Melinda Gates Foundation Grand Challenges Explorations Award to develop a Vaccine Indicator and Reminder (VIR) band and is working in collaboration with Timestrip to develop the innovative device, reminding parents for timely completion of their children’s vaccines.

Vaccine Indicator Reminder system

Working in partnership with Timestrip® and design consultants Daylight, Dr. Noor Sabah Rakshani from TVI has created the Vaccine Indicator Reminder (VIR) band to provide a simple, low-cost method of showing when each of the three rounds of vaccines needed over the first 14 weeks of a child’s life are due, alerting the mother with a clear visual marker at 6, 10 and 14 week intervals.

Whilst the World Health Organisation estimates that vaccinations help save over 2.5 million lives each year globally, figures indicate that up to 60% of children in Pakistan do not complete the immunization schedule.

Those with a vaccination reminder card achieve above 80% vaccination completion but if no card is available, or if the card is lost or damaged, the child may miss a lifesaving vaccination.

This new ‘wearable’ healthcare reminder solution is being heralded as a breakthrough solution, thanks to the revolutionary application of a Timestrip® indicator manufactured into the durable, soft plastic waterproof VIR band, which is attached to the baby’s ankle.

Each VIR band is marked with a unique number to match the child’s medical records at the point of issue.

The failsafe and irreversible nature of the Timestrip® technology (activated by simple finger pressure) shows each of the 6, 10 and 14 weeks vaccination milestones.

As the highly visible red indicator liquid (a food grade dye) sealed inside the Timestrip® migrates along the clear window, the three vaccination periods are graphically marked.

Timestrip’s patented ‘liquid’ technology ensures the accurate passage of elapsed time over the entire 18 week period.

There are no moving parts or electronics, just good science helping mothers and carers follow their child’s vital vaccination program with nothing but a quick glance at their baby’s ankle.

Dr. Noor Sabah Rakshani is excited at the progress made since the first VIR Bands were shipped to Pakistan late last year.

“We started our community effectiveness trial on October 28, 2014 in four study sites in Karachi, Pakistan. As of February 2015 the team has enrolled 344 children in the intervention and control groups, with 200 wearing the VIR band and 144 children in the control group receiving only the routine immunization card.

We have started receiving input from the parents as they come back for their second and third doses of the vaccine at 6, 10 and 14 weeks time.

Aside from the vital funds and invaluable support this pilot study has received from the Gates Foundation, an application for a GAVI grant to introduce the VIR band through a community midwifery program is also in the works.

The idea is for every midwife to give an activated VIR band to every infant they attend to in the community, and the VIR band will indicate to the parents the ‘Number of Weeks Unprotected’ for their child.

We are taking small but very important steps in our quest to protect children from vaccine preventable illnesses across Pakistan and around the world. The environmental friendly low cost and widely used Timestrip® technology has made it possible for the VIR band to be tested in low income communities in Pakistan and and I am thrilled to be working with the team.”

Commenting on the VIR band project, Timestrip® Founder Reuben Isbitsky said:

“We have a long history of innovation in the medical and pharmaceutical sectors, including the development of temperature monitoring products for blood products and vaccines. This project has allowed us to support the creation of a simple but life-saving product that could help millions of children who suffer through incomplete vaccination regimes. We are absolutely delighted to be helping bring about change in this vital area of work.”

Timestrip is proud to announce the successful certification to ISO 13485:2003 Quality Management Standard for Medical Devices in addition to our recent recertification of ISO 9001:2008.

Recognised around the world, the ISO 13485:2003 registration is based on eight quality management principles. These include: customer focus, leadership, involvement of people, process approach, system approach to management, continual improvement, fact-based decision-making and mutually beneficial supplier relationships.

The certification of the Company’s compliance with ISO 13485:2003 recognizes the policies, practices and procedures of our firm to ensure consistent quality in the products provided to our customers. With this certification, our medical and non-medical clients can be confident that Timestrip is dedicated to maintaining the highest efficiency and responsiveness achieving our ultimate goal – Guaranteed Customer Satisfaction.

Timestrip is certified as meeting the requirements of ISO:13485 for the following activities: DEVELOPMENT AND MANUFACTURING OF SMART LABELS FOR MEDICAL USE.

To maintain our certification, Timestrip will perform annual audits to ensure compliance and to assess initiatives for continued improvement. Our customers can be confident that Timestrip will continue to provide the high quality services they have come to expect well into the future.

We believe that our decision to become ISO 13485 Certified is a proactive one that not only anticipates the demands of our customers, but also demonstrates our commitment to providing quality services to all our customers in the medical industry. We strongly believe augmenting our certification offers our customers a “Best-in-Class” choice for smart labels.

The accreditation also supports our work in pharmaceutical categories, where a range of Timestrip products are used to identify temperature breaches in highly regulated cold chain environments. We are helping to protect patients and prevent unnecessary wastage of many drugs, vaccines and blood products, where the 2-8°C/46°F storage range is critical to so many products.

Timestrip indicators are leading the market in the provision of low-cost temperature indicators, as demonstrated by our blood bag temperature monitoring labels. In 2013 we launched the Timestrip Blood Temp 10 indicator, in response to the need to reduce wastage of precious blood stocks, discarded through uncertainty around temperature breaches incurred when bags are in use and removed from carefully controlled refrigeration storage units in blood banks.

In 2014, Timestrip UK Ltd announced it is working with Belgian Red Cross-Flanders to develop new blood temperature monitoring labels with a product development program looking to create optimal temperature  monitoring labels for the blood collection, distribution and transfusion organisations operating within the Flanders catchment area.

Temperature monitoring labels based on the existing Timestrip Blood Temp 10 product are now being developed and reviewed in consultation with Belgian Red Cross-Flanders.

Also in 2014 we were proud to be the technology of choice for an innovative new product created to provide a wearable, low-cost vaccination reminder product for new-born children.

The Bill Gates Foundation funded Vaccine Reminder Band is currently undergoing field trials in Pakistan. Timestrip has a long history of innovation in the medical device sector and we now provide a range of products which act as invaluable visual aids to doctors, patients and healthcare workers.

For example in the UK, a number of NHS dispensing pharmacies are already using Timestrip® PLUS to monitor the cold chain for temperature-sensitive drugs such as Neulasta® and Total Paternal Nutrition (‘TPN’) products.

Timestrip is committed to quality assurance processes and procedures and we see the ISO 13485:2003 Quality Management Standard for Medical Devices accreditation as a natural progression of our work in the specialist markets in which we aim to excel.

Clinical Innovations Rom Plus™ Fetal Membranes Rupture Test with Timestrip®

With an accurate diagnosis of PROM (premature rupture of membranes),  patients can receive interventions to minimize the risk of complications.

ROM Plus™ is a self-contained test  designed by Clinical Innovations that comes packaged for use in either a POC (point-of-care) setting or in the lab. The cassette has a built-in twenty minute time monitoring Timestrip® indicator and lateral flow test strip as well as a patient ID field.

Clinical test timer

The built in Timestrip® time indicator measures the length of time elapsed between the beginning of the test until the time the results can be read.

The results manifest within 5-20 minutes. 5, 10 and 20 minutes are clearly marked on the Timestrip®, allowing for clinicians to have a clear visual indication of when results are ready.