Timestrip®, the developer of smart indicator technology, has developed an important new range of indicators to help healthcare professionals meet WHO guidelines in the handling of virus specimens.

The Timestrip Virus Specimen Transport (VST) series has been specially formulated to provide a clear indication when key temperature levels are exceeded.

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.

The VST range of indicators includes a product specifically for monitoring temperatures exceeding 53°C.

FDA and WHO regulations state that it is important to avoid freezing and thawing of specimens.

The Timestrip VST 0°C will 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.

The new Virus Specimen Transport products are available now from Timestrip.

for release 11^th June 2020

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.

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. Timestrip indicators make excellent cleaning reminders for surfaces, filters and instruments.

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 – 65ºF (13-18ºC) 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 (26ºC) 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 20ºC and 25ºC (tolerance +/- 1ºC), 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.

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

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

Tenet Healthcare is a healthcare services company is using Blood Temp 10 temperature indicators to monitor blood transportation. PDC Healthcare surveyed the company on their experience with the indicators. The survey reported the blood bag temperature indicators helped them significantly improve blood transportation quality control and workflow efficiency.

The Blood Temp 10 indicators helped Tenet Healthcare comply with regulatory guidance by having auditable proof blood core temperature was maintained when being returned to the blood bank.

Read the full case study below:

Tenet Healthcare Blood Transportation Case Study

Riverside Health System is a healthcare non profit that is using Blood Temp 10 temperature indicators for blood temperature compliance. PDC Healthcare surveyed the organization on the efficacy of the indicators. Their survey reported the blood bag temperature indicators helped them significantly improve blood transportation quality control and workflow efficiency.

In turn, the real time temperature monitoring increased patient safety and quality of care was improved.

Read the full case study below:

Riverside Health System Blood Temperature Compliance Case Study

For more information on PDC Healthcare click here.

For the full survey on TechValidate click here.

PDC Healthcare surveyed Decatur Memorial Hospital about the benefits of using Blood Temp 10 indicators. Their survey found the blood bag temperature indicators used to measure blood core temperature helped the hospital improve the quality of care and significantly improve blood transportation quality control to comply with the FDA regulatory guidelines.

Read the full case study below:

Decatur Memorial Hospital Blood transportation Case Study

For more information on PDC Healthcare click here.

For the full survey on TechValidate click here.