GDP 2023
/ By Stéphane MURE / Non classé/ 0 Comments

GDP requirements (Updated Jan 2023)

Is it acceptable that storage conditions are not monitored for medicinal products which do not have any predefined storage conditions on the outer packaging?

No. According to the PDF icon Guideline on declaration of storage conditions (CPMP/QWP/609/96 Rev. 2) , marketing authorisation holders have to provide stability data for storage conditions at 25°C / 60% relative humidity (RH), or 30°C / 65% RH (long term) and 40°C / 75% RH (accelerated), in order to justify not including a statement in the medicinal product labelling.

This stability data is generated according to the temperature and humidity conditions of climate zone I (temperate) and II (Mediterranean/subtropical) in Europe. For more information, see the World Health Organization Expert Committee on Specifications for Pharmaceutical Preparations forty-third report, Annex 2: Stability testing of active pharmaceutical ingredients and finished pharmaceutical products.

No labelling statement means that controls should be in place to maintain conditions relevant to climate zones I and II. Consequently, the temperature should be monitored during storage and transport. Appropriate limits should be set for temperature monitoring to ensure that product stability is not adversely affected.

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USB Temperature Data Loggers

Sensolabo® USB Temperature Data Loggers Offer a Universal Solution …

Indicateur de retournement ou renversement
/ By Stéphane MURE / Tilt Indicator/ 0 Comments

What is a Tilt Indicator?

A tilt indicator, also known as a reversal indicator, is a single-use device. It allows to visually check if an object on which it is usually stick has not been turned over or too much, a situation that could lead to its breakage or damage. The tilt indicator is mainly used in transport and logistics.

Its appearance deliberately attracts the attention of the operators in the supply chain. It encourages them to take special care during handling. The indicator allows a consignee to establish an extremely fast report on the state of the products which are delivered to him. The recipient can thus take the necessary reserves in order to preserve its interests but also those of the shipper.

Its cost, generally modest, and its great ease of use contribute to its widespread use during the transport of the most sensitive products. Find here the latest generation of Thermolabo Tilt indicators.

Indicateur de Choc pour le Transport
/ By Stéphane MURE / Shock Indicator/ / 0 Comments

What is a Shock Indicator?

A shock indicator is a single-use device. It allows to visually control if an object on which it is usually stuck has not undergone a shock that could cause its breakage or its damage. The shock indicator is mainly used to monitor handling in transport or during storage.

Its appearance deliberately attracts the attention of operators in the supply chain. It encourages them to take special care during handling. The indicator allows a consignee to establish an extremely fast report regarding the condition of the products delivered to him. The recipient can thus take the necessary reserves in order to preserve its interests but also those of the shipper even if no damages are visible.

Its cost, generally modest, and its great ease of use contribute to its widespread use during the transport of the most fragile products. Find here the latest generation of Thermolabo Shock indicators.

Enregistreur de température USB
/ By Stéphane MURE / Non classé/ 0 Comments

What is a USB data logger?

A USB temperature data logger is an electronic device used to record and store temperature data. It is able to provide the history of data recorded from its internal memory to a local computer on which it is plugged.

The USB temperature data logger is used to monitor the storage conditions of a thermosensitive product during a period of storage or transport. Placed as close as possible to the products it monitors, it simply allows, after a period of time, to demonstrate or not their conformity according to predefined acceptability criterias. Its use is particularly widespread in the food industry or in the pharmaceutical industry.

It usually comes in the form of a USB key, the shapes and dimensions of which may vary between different manufacturers. It can be disposable or reusable depending on its intrinsic characteristics and may or may not have an LCD display screen.

The temperature data logger should not be confused with a temperature indicator. The difference between the two is about the same as that between photography and cinema. The recorder has an internal clock which makes it possible to time-stamp each measurement and to obtain the complete sequence and history of the recordings while the indicator only allows to obtain a snapshot which indicates whether or not acceptable thresholds have been crossed, without indicating when this happened or for how long.

The first USB temperature recorders appeared in the late 90s. They initially required a reading software interface that had to be installed on the reading computer beforehand. In the mid-2000s, USB temperature loggers became capable of self-editing a report and a temperature curve directly in PDF format. The temperature logger then behaves like a USB key on which you simply retrieve the PDF document of data history.

Today, especially in applications related to the pharmaceutical industry, this simplicity is encountering limits and is increasingly faced with regulatory and safety requirements. In fact, when the data analysis is not carried out at the place of reading, the use of USB recorders requires manual extraction and transfer of files which cannot guarantee the absence of transmission errors, nor true data integrity.

In addition, the legitimate strengthening of security requirements in the face of increased risk of computer attacks is restricting the use of removable media a little more every day. USB recorders are banned by security-conscious companies. See our article https://thermolabo.com/en/usb-data-loggers-what-risks/

Nevertheless, this type of recorder remains one of the easiest media to use and retains many advantages. An integrated monitoring solution such as Sensolabo USB makes it possible to guarantee data integrity thanks to a proprietary system for verifying and authenticating files when they are deposited in the cloud. In addition, the possibility of auditing the computer code and manufacturing with recognized subcontractors makes it possible to ensure control of the computer risk.

Logo Emirates airlines
/ By Stéphane MURE / Transport/ 1 Comment

Sensolabo® NFC Temperature Data Loggers Approved by Emirates Airlines

Sensolabo recorders are compliant with IATA requirements and can be shipped by air in accordance with UN 3091, Packing instructions 970 section II on lithium cells and batteries.

Equipped with a lithium button battery, Sensolabo requires no specific labeling.

Moreover, unlike Bluetooth technology, NFC technology is a passive technology that does not emit radio waves. Sensolabo does not need to be stopped during flights and does not require any special authorization from airlines.

Find here the approval of the airline Emirates.

Utilisation en vol de sensolabo
Emirates Airlines has approved Sensolabo data logger for in-flight use on all of its aircraft.
Détecter les excursions de température pendant le transport
/ By Stéphane MURE / Compliance/ 0 Comments

Full temperature traceability of pharmaceuticals in 7 seconds

How to combine modern technology and many years of experience in supply chains of pharmaceuticals around the world?

The cooperation between the French-Polish company Blulog and Thermolabo from France shows how to.

The strength, efficacy, and potency of a drug can be profoundly degraded by changes in temperature and drugs should be stored and transported only within temperature conditions under the terms of their Marketing Authorisations (MA) if defined.

Any excursion outside this range may result in having an influence on the main degradation factors of drugs and/or potentially lowering or losing the therapeutic effectiveness of a drug.

Exposed to external conditions, transport is one of the least reliable pharmaceutical processes and in the real life, excursions during transportation are not rare events.

An effective temperature monitoring is therefore an essential component of Good Distribution Practice (GDP) followed by the people dealing with transport, storage, and distribution of pharmaceuticals before their final dispense to patients.

In this context, Stéphane Mure founded Thermolabo in 2015 to help pharmacists and Qualified Persons (QP) to provide billions of people access to high quality medicines.

“Thermolabo’s activity was initially focused on temperature data management and dataloggers supply services. We were constantly obliged to address the same problems generated by traditional dataloggers and decided to look on how to provide our customers a compliant, easy to use, geolocated and low-cost way to monitor their pharma products.

After testing GSM, Bluetooth and IoT technology, it become quickly clear that only NFC Contactless technology can fit with all expectations and we engage a partnership with Blulog to develop a pharma-centric contactless monitoring solution.” says Stéphane Mure, CEO at Thermolabo.

From the beginning, the French company initiative was driven by simplicity.

“Above all, a NFC contactless datalogger is very easy to use. With one movement in less than 2 seconds, thanks to Sensolabo® it is now possible to read, send and instantly store the data and being alerted by email without any technical installation.”

The developed solution now brings enhancement in all fields:

“Sensolabo® strengthens compliance by eliminating data manipulations and reduces goods receiving time and workload…it only takes 5 seconds to start and 2 seconds to process..that give you all your time to monitor serenely”.

The French company bases its services on modern technologies. The key is cooperation with Blulog, a Polish-French company that has found and patented an intuitive solution to support temperature monitoring. The system works on the NFC technology. Credit card size data loggers perform measurements with a setup measurement interval and are equipped with a coin cell battery and the data is encrypted and collected in the application.

“Our data loggers measure the temperature with accuracy of +/- 0.2 ° C in the range from 0 to 30 ° C and +/- 0.4 ° C in the remaining range. Detailed data is available at all times using any Android, NFC-equipped phone or special readers. Then users can store data on a secure server, get access automatically generates reports and charts.” says Jérémy Laurens, CEO of Blulog.

The data loggers can be mounted in refrigerators, medical staff rooms, but also in containers or vehicles used for transporting medicines. Such a range of possibilities means that the Thermolabo services based on Blulog technology are used in France or other drug companies throughout Europe, Asia and the Middle East. What’s more, an important advantage of the system is the simplicity and rapidity of use – to start the device, users have just to press the button for a few seconds.

The technology is already used by pharmaceutical companies and drug distributors around the world, major NGO-s and different medical entities, as well as other international companies, including DHL

 

 

Médicaments avec thermomètre pour surveiller la température
/ By Stéphane MURE / Technology/ 0 Comments

What is a Data Logger ?

Temperature Recorder

For the pharmaceutical industry, “data logger” is widely used to designate a device used for monitoring thermo-sensitive pharma products during transport and / or temporary storage.

Battery-powered, formerly mechanical, the data logger is today an electronic device that can be programmed to record individual values over periods of a few hours to several months.

Mostly used to monitor the temperature conditions, according to the versions, it can also measure the relative humidity and thus ensure that the pharma products have not suffered any degradation during the transport phase.

Data Logger Management

There are today a multitude of brands and models of data loggers. Most of the time, the data logger is usually a connectable device that must be plug to a computer to extract the data. This implies in the first place to have the data logger to have the data.

For users, given the complexity of logistics flows, it is frequent to manage several types of recorders at the same time in a total absence of common standards. Quite often, reading requires a specific cable or software and the use of USB removable media like low cost models represents a real danger for users IT infrastructure that brings the complexity to a higher level.

The management of this organization requires costly human resources whose lack of efficiency is often deplored. Therefore the system is constrained by the heaviness and complexity of the tasks to be performed.

Contactless Monitoring

Driven by the digital revolution and the amount of digital data to manage, it becomes essential to automate the collection, processing of data and alerts.

The so-called near field technology (NFC) now opens up concrete opportunities that can significantly improve the operational efficiency of our cold chain monitoring processes.

Indeed, the innovative Sensolabo® NFC secures and accelerates this process.  Data extraction, transmission, cloud storage and geolocation is made within fractions of a second only…And the sender is alerted at the same time !

 

Data loggers - Pourquoi changer pour le NFC ?
/ By Stéphane MURE / Technology/ 0 Comments

Data loggers – Why Should You Change for NFC ?

NFC is Easy to Use

Above all, an NFC data logger is very easy to use. It does not require any user training and does not require a cable or computer to be read.

In a single gesture and without contact, it is now possible to read, send and store temperature data instantly.

Watch in video

 

3 billion reading possibilities

You just need an NFC Smartphone and approach it to the data logger so that it starts automatically! It works with Android phone and Iphone (from 7 or higher)

You are never short of solutions, there are more than 3 billion compatible smartphones in the world.

The list of NFC Smartphones

 

Technological, Practical and Affordable

An NFC data logger is more than just a robust and affordable temperature recorder, it gives you access to premium features like geolocation at each reading.

Discover our range on the online store

Data loggers USB - Quels Risques pour votre Entreprise ?
/ By Stéphane MURE / Technology/ 0 Comments

USB Data loggers – What Risks for your Company ?

USB Data loggers : An Important Risk

According to the Allianz 2017 risk barometer, companies cite cybers incidents as the third most important danger and these fears are justified when speaking about USB data loggers !

Among the most important risks, the infestation by the USB removable supports represents a real and serious threat. The situation is to the point that, gradually, USB storage media are banned by companies concerned about their safety.

 

The End of USB Data loggers

Hardware manufacturers themselves remove gradualy the traditional USB 2.0 plugs from their computers.

As an example, Apple have already removed USB plugs from some of their models.

The IT security policies of many companies now force to return all removable media such as USB dataloggers to their owners…

 

Hacking

The USB hacking technique is one of the most effective. According to Wikileaks, the CIA itself has developed a hacking technique based on removable storage media…  A mechanism that has already been exploited by Stuxnet, the malware that infected the centrifuges of the uranium enrichment program of Iran.

Do the USB security risks and the emergence of new modes of communication (NFC, Bluetooth) are pushing the traditional USB dataloggers towards the exit?

 

Let’s discover our range of NFC dataloggers