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.

adminTimestrip Procedures Certified to Updated ISO Standards
read more

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.

adminTimestrip Complete: Q&A
read more

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
Frame
Zoom
Focus
Snap

 

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.

google-play-badge

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.”

adminNew Timestrip App: Digital Data Logger Performance at Analogue Prices
read more

What is all the “wine’ing” about?

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 – 65F (13-18C) 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 (26C) 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 20C

Timestrip offers a full range of stock labels including two that have a temperature breach of 20C and 25C (tolerance +/- 1C), 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.

adminWhat is all the “wine’ing” about?
read more

Timestrip UK Launch Longer Breach Time & Temperature Indicator For The Pharmaceutical Industry

Timestrip UK Launch Longer Breach Time & Temperature Indicator For The Pharmaceutical Industry

Timestrip UK Ltd have expanded their range to include their latest Timestrip PLUS™ 10° threshold indicator with a 7-day run-out/recording window. This specific indicator is meeting the demand within the pharmaceutical industry and the regulations and compliance that come with transportation and storage. With Timestrip’s latest 10° 7 day offering, they are reaching out further within the Pharmaceutical and Healthcare industry and ensuring their high tech but low cost devices are evolving with the relevant advances in the industries.

Timestrip design and manufacture innovative, irreversible time and temperature indicators for a range of industries from Food to Pharmaceutical. Their Timestrip® PLUS range is predominantly used across the Healthcare, Life sciences and Pharmaceutical arena. Currently, the Timestrip PLUS™ range covers temperature thresholds from -20°C up to 38°C and generally display a run-out window of any temperature breach for 8, 12 or 48 hours.

7DayPhotoCombining time & temperature monitoring patented technology, which involves controlled rate lateral diffusion of liquids through the device membrane once activated. If a breach occurs, the ‘smart’ indicators will visually indicate how long a product has been exposed to higher temperatures.

For a free sample of the new 10° 7 day indicator, or to place an order click here

adminTimestrip UK Launch Longer Breach Time & Temperature Indicator For The Pharmaceutical Industry
read more