Timestrip Procedures Certified to Updated ISO Standards

Timestrip Procedures Certified to Updated ISO Standards

Interview with Reuben Soncino, Timestrip’s Quality Assurance Officer

What exactly is ISO certification?

ISO is the acronym for International Standard Organisation. When a company has ISO certification, this means that it meets certain standards around quality levels and compliance with ISO standards.

For instance, this relates to inspections, production processes, how goods received are inspected, the management of irregularities that occur during production, the packing of finished products, what documents need to be included in shipped products, etc.

Why is ISO certification important to Timestrip?

It means Timestrip’s management systems have attained a required level of quality around the production and release of our finished products. There is no ad hoc decision-making in what we do. Everything is controlled and monitored.

Hypothetically, for example, if a customer complaint was to arise, we have a system in place to manage this. Furthermore, having ISO 13485 certification which concerns medical equipment, means that we have even stricter systems beyond the more general purpose ISO 9001 certification (which we also have).

One area that ISO 13485 relates to (but not ISO 9001) is around the validation of software used in our production and product release processes.

What does achieving ISO 9001 and 13485 certifications involve?

Once a year, we are audited by external auditors for both certifications and this is carried out by the Institute of Quality Control (IQC). The one-day audit is to certify that Timestrip complies with ISO 9001 and ISO 13485 standards. We are audited for both standards at the same time.

Also, every three years, we are re-certified. This is involves a two-day audit and re-certification is valid for three years. For ISO 9001, we were first certified in 2010 and so re-certification needs to be organised for next year (2019). For ISO 13485, Timestrip was first certified in 2015 and we have just been re-certified until 2021.
This was particularly important as this re-certification also involved an upgrade to the new ISO updated standards.

What did meeting the updated ISO standards involve?

Prior to the audit, we carried out a so-called “gap analysis” to identify areas in our procedures that didn’t meet the new standards. These needed to be updated, plus we had to put in place new procedures as well as training for all our teams. We also had to implement a few minor corrective actions, such as adding a job description for one of our team members.

In fact, when I first joined Timestrip in 2009, operations complied to a very large extent with ISO standards. However, this had not been validated and making this happen was one aspect of my role: first, to achieve ISO 9001 certification around our TTIs to food products and pharmaceuticals customers and then ISO 13485 when we moved into servicing customers involved in storing and transporting blood products.

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Seafood Expo North America is this weekend – Get the Press Kit

We will be showing off our Timestrip Seafood indicator for reduced oxygen packaging at the Seafood Expo in Boston starting on Sunday 11 March 2018. Stop by Booth 1388 to get a sample of our Food indicators.

If you can’t make it to the show, Download our Timestrip Seafood Expo Press Kit PDF to find out more on how we utilize Timestrip temperature indicators for the Food Industry.

 

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Timestrip Attending Seafood Expo North America, Boston MA

Timestrip Attending Seafood Expo North America, Boston MA

Timestrip will be attending Seafood Expo North America in Boston, Massachusetts from March 11, 2018 – March 13, 2018.

We will be demonstrating our 3°C Seafood, 5°C, 8°C & 10°C irreversible ascending temperature indicators at the expo. Our 3°C Seafood indicator is designed around FDA guidance, the gold standard for Health & Safety and HACCP systems.

We will be at booth #1388, please come and get a sample of our Irreversible Seafood Temperature Indicators to test and take away with you. Click here for more information about our 5°C, 8°C & 10°C indicators and here for information about our 3°C Seafood indicator

Timestrip Food temperature range

Timestrip temperature monitoring labels make tracking temperature breaches across a multitude of cold chain food industry applications a simple, cost-effective process.

In fact, we offer the most cost-effective solution of our type in food standard and food safety monitoring, which is why our technology has already been adopted by a number of innovative businesses. Our precise, efficient, user-friendly temperature indicator labels are helping to ensure effective cold chain management around the world.Timestrip Seafood

Seafood Expo North America attendees meet with thousands of colleagues and suppliers to find the newest fresh, frozen, and packaged seafood products and stay current on industry trends.

Seafood Processing North America attendees share ideas, find new processing equipment, make connections and get the news on preparing, delivering and packaging seafood products. More than 22,600 total attendees from over 120 countries attend the event.

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Timestrip Complete: Q&A with Timestrip Founder Reuben Isbitsky

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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