Operational Risk Assessment in the Logistics, Pharmaceutical & Food supply chains

The big word in the logistics and supply chain “world” is RISK, and a risk assessment being performed, or at least having a mitigation plan in place, is becoming part of many certification requirements, like ISO 9001, and other pending or recently introduced federal regulations.

It will be no surprise, I am sure, when I mention certain facts like – “Where humans are involved in a process there will be errors, and 90% plus of all supply chain errors are human errors”; but how do you avoid these?

Firstly, let me say there will always be Risk not only in the common elements of the supply chain but also and especially with the way that you handle any cold chain or temperature-controlled products.

So how do you manage these risks?

There are 4 common and accepted ways that Risk can be managed, or mitigated:

  1. Risk Avoidance: Changes made to your processes and players that ensures risks are no longer an issue.
  2. Risk Mitigation: Reduce the severity of the loss or prevent the likelihood of the risk from occurring.
  3. Risk Acceptance: Avoidance of a potential risk area is not possible or economically feasible, so it is acceptable and will not impact your business.
  4. Risk Deflection: After the risk has been identified and quantified, transfer that risk to the control of another player or partner in the process – maybe add it as a clause to be addressed in a vendor contract.

So how do you establish a Risk Mitigation Plan?

  1. Review and audit your supply chain to assess where risk does, or may exist
  2. Assess what the impact of these risks may be and create a list with the highest probability items at the top to address first
  3. Define your risk mitigation strategies for the highest-level items and work down the list from High to Low
  4. Implement the strategies and document them.

What else should I do, or know?

  1. Even though your Risk Management plan includes good SOP’s and WI’s make sure that people are adequately trained in these disciplines
  2. Conduct self-audits regularly
  3. The cost of a Cold Chain Monitoring device or solution, is far less expensive than the cost of disposal of a temperature compromised shipment
  4. All Quality Systems and Risk Aversion Plans should have one over-arching goal – Quality of Product and Consumer Safety!!!!

At Timestrip we are acutely aware of all kinds of risks that can exist in all kinds of supply chains from Pharmaceutical to Food and even beyond to special chemicals and laboratory testing time lines.

For a full range of our products please visit our products page

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Timestrip Complete: Q&A

What is Timestrip Complete?

Timestrip Complete is our product that monitors upper and lower threshold temperature breaches, such as 2°-8°C cold chain monitoring for vaccine storage and transport.

timestrip complete 2-8c monitoring

The product is in fact made up of two elements: a Timestrip Plus, which is our ascending indicator that measures, for example temperature breaches above 8°C and the amount of time that they have breached, and a descending temperature indicator called Freeze Check Plus FCP for short that logs breaches, for example, below 2°C.

This is why we’ve called the indicator “Timestrip Complete”: It provides complete monitoring for the 2°-8°C cold chain.

Why was Timestrip Complete developed for vaccine storage and transport?

A vaccine is affected by heat and by freezing and the two critical temperature thresholds for storage and transport are 2°C and 8°C.

It’s time and temperature that’s the critical factor leading to degradation of vaccines.

For freezing, the crucial event is whether this has happened or not. Because vaccines are contained in an aqueous solution (water), when it freezes, it expands and the resulting crystallization can destroy the vaccine

How much does a Timestrip Complete cost?

Under US $4 per unit, and considerably less in volume purchase. It’s the lowest cost solution and easiest to implement to achieve complete 2°C-8°C temperature monitoring. Any other tool that does this job involves using a single-use digital data logger, which start at about US$10 per unit

This totally fits in with our company ethos of providing the easiest, simplest and most cost-effective products for temperature monitoring. Many 0°C or 2°C descending indicator on their own for instance normally costs at least US$2.50, so we know that our sub-US $4 price is very competitive.

How do you use Timestrip Complete?

It can be stored at room temperature, is inert until activated and has a button-like feature that needs to be pushed for activation.

There is an extra measure needed in storage to bear in mind— and this is industry-wide for all descending temperature indicators — is that they are always active.

This means they need to ship to end-users above the temperature they monitor and we achieve this by packing them with heat packs to ensure they never go below 2°C.

On the positive side from our clients point of view, because the ascending indicator can be stored at room temperature, they only need to ensure that our products are kept above freezing.

Similar products present the logistic difficulties of needing to be kept above 2°C and below 8°C, so this is a big advantage

Are there other Timestrip Complete products apart from 2°C-8°C?

Yes, this is a key range which we are looking to grow.  The product also comes as 0°C-8°C

Timestrip Complete 0°C – 8°C and 2°C – 8°C are also used for the storage and transportation of medicine and biologics.

We are now launching a Controlled Room Temperature indicator that has 15°C and 25°C thresholds. These are designed for environments such as food transportation for airlines.

The key message here though is that we have the technology to produce a variety of complete upper and lower level temperature monitoring — and at a very competitive price.

What’s been the feedback so far from end-users of these complete temperature monitoring indicators?

Timestrip was involved in supporting anti-rabies work in Malawi with a 0°C-30°C indicator for the transportation and storage of canine vaccine. Rabies is huge problem in Malawi and spoilt vaccines seriously hamper efforts to address the situation.

The bottom line was that this 0°C-30°C product was successful in identifying those doses of canine vaccine that were either spoilt because of ambient heat exposure or from freezing caused by the ice-packs that are used during transportation.

This allowed for a re-stocking with unspoilt vaccines that ensured that the anti-rabies field teams’ efforts were effective and thereby measurably supported the prevention of more cases of rabies in Malawi.

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Marathon Distributors

Marathon Distributors

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.”

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Monitoring the Canine Vaccine Cold Chain in the Field

Monitoring the Canine Vaccine Cold Chain in the Field

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 Picture4Malawi 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.

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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

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New Timestrip App: Digital Data Logger Performance at Analogue Prices

New Timestrip App: Digital Data Logger Performance at Analogue Prices

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

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

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

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

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

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High tech low cost

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

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

Like having a hundred permanent digital data loggers

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

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

Data logger functionality at a fraction of the price

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

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