MEDİLİNE Isothermal Solutions is launching its production facilities for temperature-controlled packaging by 1st July, 2015. Mediline is extending its in-depth experience, full range, Pharmaceutical GDP (Good Distribution Practice) compliant packaging and temperature monitoring to Turkey.
Legal regulations on keeping medicines and medical products safe at certain temperature intervals and thus delivering them to the patient without risking their effectiveness were published by the European Commission in September 2013 and was made strictly implemented through a series of changes and improvements. Although regulations in accordance with this legal framework have been initiated, in parallel, in our country, the legal or current practices are still not monitored within this framework. However, both with the pressure of legal regulations, which are published in Turkey, and the experience of global pharmaceutical companies acquired from European applications in recent years relating to all processes of storage and transportation, which do not allow exceeding temperature controls, are quickly reviewed.
By adapting to the new process, which establishes guidelines for the coordinated control of all stakeholders, from the State to the patient, the results are more scientific and effective. In view of these practices, the pharmaceutical industry is committed to the increased value of drug therapies and confident in protecting human health more than ever before.
Mediline Isothermal Solutions is a manufacturing and R&D company headquartered in Greece which is an EU member country where EU Pharmaceutical production and distribution regulations are implemented in the most advanced way. The company has 98% Greek market share. However, the company operates in many countries throughout Africa and Europe, as well as the United States and the UN, Mediline experience includes in-depth knowledge of different legal frameworks and temperature, road and transport conditions in these countries.
The company creates a road map by knowing the position of the Turkish pharmaceutical industry to adapt to a vital process rather than adhere to transport and packing applications which have been used in recent years, and are most economically compatible with external temperature changes, Mediline knows that companies will have to resort to “exceptional,” out of the ordinary solutions, with proven compatibility with extreme conditions. Therefore, we offer 100% reliable solution sets, compatible with extreme summer and winter conditions, based on AFNOR (French-originated, the most respected standardization union in Europe) and validated for long-term intervals.
Mediline Isobox products represent an international patented special design (puzzle set). Mediline products do not require molds, like other cold chain packaging. Our solutions can be adjusted to the desired dimensions, just like legos. Further, the very minimal amount of space is required due to its disassembly. The main material used, XPS (Extruded Polystyrene), offers much better thermal resistance properties than traditional white foam or Styrofoam material (EPS) and contains 0% moisture. This feature facilitates, not only long heat preservation times, but also in-package temperature management.
In-pack heat capacity is calculated according to the targeted time with special ice batteries; Mediline-designed formula. The fact that Mediline designed batteries can only be frozen for 24 hours and can be used directly without the need for sweating provides very important logistical contributions. In addition, it does not undergo any change in shape and discharge at any temperature with its physical properties very different from conventional ice batteries. It is also very reliable due to its non-toxic chemical composition.
Mediline not only provides mass product transport purposes, but also provides products of scale and features suitable the patient’s drug use in a long-distance journey from the pharmacy or hospital.
For compliance with the required terms and times, Mediline uses the temperature profile and documentation system of AFNOR, which is the most common standardization and measurement organization in Europe (Please look at www.afnor.org/en). Mediline research team has envisioned the implementation of the Mediterranean Advanced Summer Runs (22 – 40 °C,) for summer, the North and Central European Winter Conditions (- 5 – + 10 °C) for winter, and Mediterranean Spring/Autumn (12 – 20 °C) profiles that are based on the AFNOR (NF S99– 700) temperature profiles for Turkey; and have created their ready-made solutions according to these temperature profiles. However, the American Standard Organization ISTA and customer-specific temperature profiles can also be differentiated. It is worth noting that the above mentioned temperatures are not “Ambient Temperatures”, rather, the temperature profile inside the transport vehicle which directly affects the drug, not the conditions of the external air.
While reliable transport solutions have not yet been created for even cold chain products (2-8°C) in Turkey for 48 and 72 hours, in Europe and many countries around the world, safe transport conditions have also been carried out for ambient temperature sensitive products (15 – 25 °C or 2-25 °C) under the framework of applicable laws. Mediline has already applied validated solutions for these product groups. Widely preferred for cold chain transport but with a lower thermal strength than XPS, EPS (Styrofoam)-based materials are generally used in this kind of temperature enclosures.
Mediline will add temperature tracking solutions to this product range, with special temperature recorders and remote GPS vehicles (in-packing), very soon.
Mediline will not only offer «Temperature Controlled Boxes – Heat Controlled Packaging”, but complete heat-controlled transport systems as it expands activities in the field as a manufacturing, development and application consultancy company.
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