What are the differences between a regular
flexitank and an aseptic flexitank?
1. Sophisticated aseptic valve
2. Gamma irradiation
3. EVOH barrier (optional)
What is the difference between a regular valve and an aseptic valve?
On top of the safe loading of a regular valve, an aseptic valve can ensure the continuation of the acepticity of a product by allowing application of high temperature steam.
What is Gamma
Irradiation?
Sterilization with gamma rays is one of the most reliable, effective, and common alternative sterilization methods used today. Gamma rays are ionizing rays which can remove electrons from the atoms when they react with substances. They detach DNA molecules from living organisms which terminate microorganisms such as bacteria, parasites, mold, yeasts, or fungus.
Gamma rays are electromagnetic energy just like radio, TV waves or microwaves, visible lights, or x-rays.
What is EVOH?
EVOH stands for ethylene-vinyl alcohol copolymer. EVOH film is known for having some of the best obstruction protection from gases like oxygen, nitrogen, and carbondioxide. While we can include EVOH upon request, A-Flex comes with zero total system oxygen transmission rate even in the absence of EVOH, thanks to its positive pressure feature.
What does the dosage unit “kGy” mean?
It is the amount of the energy that is adsorbed by the ionizing radiation in the unit mass of the substrate. 1 Gy is the 1 Joule energy that is adsorbed by a substrate weighing one kilogram.
Is the gamma irradiation new technology?
Gamma irradiation has been applied with the aim of sterilization for a period longer than 50 years and there are over 200 gamma irradiation plants in 55 countries world wide.
How is the process control ensured?
In order to ensure the process control, the Harwell Perspex dosimeters, which are used for measuring the adsorbed dosage by the product, are used. In the dosimeter laboratory, the absorbance values at unit thickness are measured by spectrophotometer. The minimum and maximum dosage ranges of the product are determined through the evaluation of the dosage results obtained by statistical calculation methods and their compliances are confirmed. The calibrations of the dosimeters and other measurement devices in the facility are followed up regularly and their traceability by the competent authorities is ensured.
Which type products are not suitable for irradiation?
The irradiation of the products that were determined by the legal regulations as unsuitable for the irradiation, additionally the products that are about decomposed or decomposed, the expired products or the products that were previously subject to the other sterilization processes, the products with the damaged packaging or unsanitary packaging are not suitable for irradiation.
What does the irradiation certificate document?
It documents that the irradiation was performed at the showed dosage value of the gamma under pursuant to the regulations and standards.
How is the irradiation process realized?
The product boxes, which will be exposed to the gamma irradiation after bringing them into the irradiation room via automatic conveyor, are put inside the aluminum irradiation boxes (TOT) in their own packages without opening them. After the irradiation process, the irradiation boxes full of the products are taken outside the radiation room again automatically by the conveyor system and then the products are stored in the processed products storage area.
Do the irradiated products become radioactive?
No. Because the gamma energy of two gamma rays with energy levels of 1.17 MeV and 1.33 MeV are emitted by the Co-60 isotope as the irradiation source. These energy levels of the gamma rays emitted by Co-60 isotopes are not sufficient to make any material radioactive. For example, the foodstuff exposed to the sunrays will not become radioactive and the human body will not become radioactive when we have dental X-ray or when we pass through X-ray devices at the airports for security checking purposes. Similarly, no irradiated products by irradiation process will be radioactive.
How is the irradiated product understood?
Prior to the irradiation process, a label showing that the products were processed and an indicator changing color radiation sensitively are affixed on the packages of the products. For the medical products, the yellow-colored indicator before the irradiation turns into red color after the irradiation and for the foodstuff, the green-colored indicator before the irradiation turns into violet color after the irradiation. In addition to those, the FDA [Food & Drug Administration] approved international green colored foodstuff irradiation symbol ‘radura’ [An artificial word combining the initial letters of the word “radiation” with the stem of “durus”, the Latin word for hard, lasting] mark is affixed on the packages of the foodstuff for the indication of the performed irradiation process.
Is eating the irradiated foodstuff safe in terms of health concerns?
The following international corporations and organizations that are in consensus on the safety of the foodstuff irradiations in terms of health:
- WHO [World Health Organization]
- FDA [Food & Drug Administration]
- FAO [Food and Agriculture Organization]
- IAEA [International Agricultural Exchange Association]
- Codex Alimentarius Commission
- Scientific Committee of European Union
Why is Irradiation Method Gradually Being Preferred in the World?
Together with some amendments throughout the world, usages of Ethylene Oxide and Methyl Bromide gases have been limited. Some examples are as follows:
In 1986, in California “The safe drinking water and toxic enforcement act of 1986” draft, was negotiated and accepted in the same year. According to this draft Ethylene Oxide gas is defined as a hazardous chemical material in the category of toxic gases.
Such adjustment was supported in 2002 in Japan by the PRTR (pollutant release and transfer register) draft. These adjustments imposed great limitations and responsibilities to the manufacturers using Ethylene oxide gas in the country. In Japan, recently, 60% of medical products are sterilized by irradiation, only 30% is by Eto and the remaining 10% is sterilized by vapour.
According to this information, products that are gamma sterilized have been more and more preferred and thus their usage rate has been increasing day by day.
