Interview with Reuben Isbitsky, founder of Timestrip UK Limited, which has just received FDA clearance for its 10°C Nonreversible Blood Transit Temperature Indicator.
What does FDA clearance of Timestrip 10°C mean for your company?
It’s major milestone. Product-wise, we've been deemed and certified as having a medical device that has an accuracy level of ± 0.5°C and is suitable for transporting whole blood. FDA clearance for Timestrip 10°C will allow us to market this product for this specific application.
And for our business, it marks a very important turning point. We started off as a time indicator company, which evolved into a temperature monitoring business, that is now a high-end medical device and healthcare business.
Moving forward, our business model will be to configure new products for specific and invariably speciality uses. We’re also going to be expanding our range of products for specific uses to enable the safe transportation of the different components of whole blood as well, namely platelets, plasma and frozen blood products. This will go a long way to maximizing the usability of all these components. For instance, even properly transported and stored whole blood only has a shelf life of 35 days, but plasma can be frozen and has many uses.
Lastly, for markets outside the US FDA clearance gives our product enormous credibility. Although FDA clearance cannot be enforced outside the US, in fact for many markets such as Saudi Arabia and India, it is used as an indicator of credibility and for tendering processes is even a prerequisite.
Timestrip is pleased to announce the arrival of our 6ºC blood bag temperature indicator- Blood Temp 6.
Blood Temp single use temperature indicators
Blood Temp 6 single use temperature indicators are low cost, field activated, and irreversible – they have been designed to be adhered directly to blood bags and are calibrated specifically to monitor the 6ºC threshold.
Use for monitoring temperature exposure when blood bags are in transit from storage, as in hospital blood banks. Blood Temp 6 provides a simple visual indication that blood has been stored and transported below 6 degrees Celsius.
Along with our existing 10ºC product, Blood Temp 10, and our 25ºC Extreme room temperature indicator, Timestrip Plus 25ºC, Timestrip indicators are ideal for all your blood bag monitoring needs.
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.”
DHL Global Forwarding opened it's purpose built temperature controlled warehouse to process pharmaceutical, biotech and medical devices in Chicago's O'Hare airport.
With 10,000 temperature controlled square feet situated in the world's busiest airport, businesses now have better ways to get their temperature controlled healthcare products all over the globe.
Whether your products are being flown internationally, or shipped overground locally, you need to be sure temperature breaches have not occurred in transit.
Temperature monitoring in pharmaceutical warehouses
Timestrip® has a line of temperature breach indicators that are small, easy-to-use, cost effective indicators that and provide auditable proof that your devices arrived safe to use.
Our Timestrip® Blood Temp 10 indicator is a single use ascending temperature breach indicator that can be applied directly to a blood bag, and will visually alert you to a 10°C breach of the blood bag's core temperature.
For all other temperature monitoring needs, our Timestrip® PLUS line monitors ascending temperature breaches in a variety of temperatures between -20°C and 30°C.
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.
Frostine's: Major Korean beauty brand LG's skin care line
Timestrip indicators were added to the base of glass bottles used across the Frostine’s range by LG cosmetics as it launched its revolutionary new brand across Korea in one of its biggest multi-channel campaigns of 2012.
LG is the second biggest cosmetic brand owner in Korea and the Frostine’s brand extends its reputation for innovation in the sector.
The Frostine's range comprises toners, eye creams, masks and moisturizers with a unique formulation that requires the products to be kept refrigerated at all times.
Skincare efficacy timer label
In addition to the chilled characteristics, some of the creams and toners lose their efficacy after 6 weeks, so each bottle comes with a Timestrip applied to the base so that consumers can trigger the timing label and check the product integrity at a glance each time they are used.
See their custom Timestrip design and unique cosmetic integration from 1:50-3:00 in the video.
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.
Timestrip was on display at the Exhibit Hall in the impressive Pennsylvania Convention Center during the 2014 AABB Annual Meeting in Philadelphia, PA from the 25-28 of October.
Among the top medical devices and compliance tools for blood banks and hospitals being shown to AABB members from around the globe, our Blood Temp 10 product had its own display at the GenesisBPS booth.
We had fun meeting AABB members and demonstrating how our Blood Temp 10 product works.
Blood temperature breach indicator
Timestrip Blood Temp 10 is an irreversible, single-use 10ºC temperature breach indicator. It can be stored and shipped at room temperature when inert and is activated with simple finger pressure.
Once activated a confirmation window tells you the product is ready to monitor by filling with colour. It is then immediately adhered on the lower third of a pre-chilled blood bag.
Blood Temp 10 is ideal for the transportation of blood bags. When the core temperature of the blood breaches 10ºC, the indication window turns blue, showing you the blood is no longer suitable to return to storage.
If you missed out seeing us at the AABB 2014 Annual Meeting, you can read more about Blood Temp 10 here.
If you liked the clear breach indication and ease of use of Blood Temp 10, but need to monitor extreme room temperature breaches, then have a look at our Timestrip Plus ascending temperature breach indicators here.
Belgium Military Hospital uses Timestrip Temperature Indicators to help protect vital blood stocks - PRESS RELEASE
Smart label pioneers Timestrip, working with their Benelux distribution partner INNOLABEL, have confirmed that the Queen Astrid Military Hospital in Belgium has adopted a temperature control regime for red blood cells, platelets and plasma using Timestrip Temperature Indicators. Application of the Timestrip labels is helping to expose potentially fatal changes caused by damaging ascending or descending temperature and prevent unnecessary wastage of valuable life saving products through accurate temperature monitoring outside the cold chain
In addition to ongoing patient care and clinical research conducted at the hospital, there is a burns center and a blood bank taking donations from the active military and local civilian defense staff. Patients in the burns center are treated with blood products from the blood bank, along with children in the Hematology Oncology Center at the nearby Queen Fabiola Hospital.
Blood products are also shipped abroad to treat service personnel on foreign assignments, often in lifesaving scenarios.
In line with the Federal Public Health regulatory guidelines, the red blood cells, platelets and plasma are collected, processed and stored at their prescribed temperatures until released from the cold chain. Red blood cell concentrates are stored in refrigerators at +4 °C. Blood plasma is frozen to -80 ° C. Platelets are stored at a temperature of +22 ° C and gently agitated to prevent coagulation. The temperature in medical refrigerators is constantly monitored and reported, in line with regulatory demands.
However, the transportation of the red blood cell concentrates from the blood bank refrigerators to the care unit or operating theatre takes place in refrigerated boxes. It is here where Timestrip indicators become the guardians of product quality, monitoring individual product consignments for temperature abuse.
Timestrip indicators are activated by simple finger pressure and placed directly on to blood bag labels, monitoring the core bag temperature and providing clear visual indications of temperature excursions between 2-8 °C - including the length of time of that excursion. Freeze indicators also used on products to identify if a damaging temperature descent has occurred below 0 °C, either at altitude or in severe cold climates.
Timestrip indicators show that the necessary transportation temperatures (outside of the controlled cold chain) have been maintained. As a result, decisions regarding the permissible return of stock to the blood bank, or the safe use of products kept in cool boxes over a prolonged treatment period are made possible. The failsafe nature of the Timestrip technology and the irreversible display readings remove all ambiguity from the quality checks.
Without Timestrip indicators, the care teams would be obliged to follow The Federal Public Health guidelines that demand red blood cell concentrates returned to the blood bank are destroyed, if there is no proof that optimal storage conditions were maintained. The result is that invaluable blood products are destroyed by this lack of certainty. In the past, this ambiguity has led to significant wastage of perfectly good product, which is both costly and ethically uncomfortable to front line teams who know that blood donors give blood to help protect life, not see their donations discarded due to ambiguity.
Commenting on the adoption of Timestrip indicators, Dr. Christian Vandenvelde, Head of the Military Department for Blood Transfusion observes "By using the freeze indicators we can tell if the product has been frozen during storage or transport. Should an error occur and, for example, platelets have been kept in a freezer instead of at room temperature, then the freeze indicator makes this temperature abuse absolutely clear. With red blood cells, freezing causes the red blood cells to break down and if the temperature rises too high then bacteria could multiply to dangerous levels."
There are no special storage requirements for Timestrip labels which makes handling much more efficient when compared to other indicators. This is critical in operational terms, given that the blood bank teams have identified the need for speed when it comes to ID-tagging red blood cell concentrates once removed from the cold chain.Lieutenant France T'Sas, Doctor in biomedical sciences, has seen a big improvement in the way products are handled, commenting ''By using the TimestripPlus label, we noticed that there was already a limited excursion of the optimal temperature during ID - tagging of the red blood cell concentrates. The fact is that it warms up quickly, while it takes much longer to cool down. Timestrip indicators have helped identify this and as a result we have adapted and speeded up our procedures to prevent these excursions. The TimestripPlus label is very user friendly, very accurate and readable to anyone without any additional explanation.''
Dr.Vandenvelde concludes, "By applying freeze indicator and a TimestripPlus label, we can demonstrate that we now have continuous temperature monitoring of our blood products. This also means that we have more certainty on the storage conditions in order to take back blood products. Moreover, any human error can be discovered and critical mistakes avoided.
As a results of these advances in red blood cell product monitoring , we are now also using Timestrip labels with different temperature limits to apply to the platelets and plasma , because here continuous temperature control is an absolute must. Also, the cost of a TimestripPlus label is negligible in relation to the value of the blood products. These life saving products are too precious not to employ all means possible in order to improve our procedures, ensure quality and remove unnecessary wastage.
"The Belgium Military logistics teams are also using Timestrip indicators for temperature control of red blood cells during air transport to Africa, where they have soldiers in active service. All air transport equipment is validated for the transportation of red blood cell concentrates and both the Timestrip Plus and freeze indicators are used inside the validated shippers to help front line medical teams keep an eye on optimal temperatures during transport.
2013 saw the launch of several new products in the Timestrip range and a significant uplift in enquiries from within key sectors such as pharmaceuticals, life sciences and healthcare.
One such example being the Temp 10 temperature breach indicator label created for blood bags – now saving time, money and lives in blood banks across Europe and the USA.
Timestrip time temperature innovation
Innovation remains a core strand of our dynamic approach to solution development and the practical application of patented, low-cost smart label indicators.
As a result the company is looking to appoint a raft of new sales and marketing partners for its entire range, with a focus initially on mainland Europe.
Organisations with expertise and established routes to market within cold-chain markets in pharmaceuticals, medicines, vaccines, blood products and life sciences are invited to make contact for initial consultations with us via our contact page.