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.
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.”
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® has a new range of Food Temp™ indicators which have been specifically developed for food shipping and storage.
The newly designed temperature breach window on the Food Temp™ 5°C indicates breaches lasting between two to four hours.
Why 2 Hour – 4 Hours?
In the food industry, food with the potential to grow hazardous pathogens are kept safe from developing harmful levels of bacteria using a HACCP Plan with a 2 Hour - 4 Hour Rule.
If the food is exposed to a temperature breach for less than 2 hours, bacteria have not been developing quickly and can be returned to the safe temperature.
Users can see that the breach window on the Food Temp™ indicator has remained white and can return products to the safe temperature.
If exposed to breach temperatures above 2 Hours, but under 4 Hours- bacteria levels have begun to rapidly multiply but have not reached dangerously high levels.
When users see blue in the breach window, it will alert them they must use the food immediately and cannot be returned to storage.
After a 4 hour exposure to a temperature breach, bacteria have had the time to multiply to unsafe levels and cannot be consumed.
A completely blue window on a Food Temp™ indicator lets a user know that the food product is unsafe to use and must be immediately discarded.
For more information, see our Food Temp Indicator page.
From Johns Hopkins Public Health Magazine
https://magazine.jhsph.edu/2015/fall/features/the-dream/index.html