Medical Equipment Sterilization

Gamma Sterilization Technology

Sor-Van's cobalt-60 facility produces gamma radiation. Gamma radiation is ionizing electromagnetic radiation, with similar properties to X-rays. Gamma radiation breaks DNA and RNA molecules of microorganisms' (germs, bacteria, fungi, and mold) and thereby neutralizes them. The process is carried out on sealed packages, without the contents being exposed to any physical or chemical contact. It must be emphasized that under no circumstances is there any possibility that products which were processed at Sor-Van will undergo activation and become radioactive themselves. 

 

The sterilization process is a "cold" one, recognized worldwide as "cold pasteurization" – any warming that the product undergoes is as a result of energy introduced in the process, and is not essential to the sterilization process itself. Sterilization can therefore also be carried out on frozen products, and even on packages containing ice. Moreover, the process does not involve the use of any chemicals, thus avoiding the risk of foreign substances being absorbed by the sterilized product. The duration of the process is relatively short (1-4 hours of irradiation, depending on the required dose). The product can be used immediately following the process, without the wait times or ventilation processes commonly required by other sterilization processes. 

Dose Measurements

The radiation dose is measured in KiloGray [kGy], which expresses the amount of energy absorbed by the material ( 1 [Gy] = 1 [J/kg]). The required sterilization dose for products, is directly linked to their bioburden. In most cases, a 25 kGy dose is more than enough to guarantee a Sterility Assurance Level of SAL 10^-6 (less than one in a million chance of a microorganism surviving the entire sterilization process). Customers may also set lower or higher sterilization doses, depending on their item's requirements and bioburden.

  • Medical Equipment – a variety of disposable plastic accessories: needles, test tubes, infusion stopcocks, connectors, and catheters, as well as surgical gloves, clean room dressings.
     

  • Packaging – aseptic bags for medical equipment and the food industry, as well as packaging for diagnostic products.

  • Reusable Medical Equipment – catheters, various tubes, accessories and devices, and clothing for operating and clean rooms.
     

  • Food – spices and medicinal herbs.
     

  • Cosmetic Products

Products Suitable for Gamma Ray Sterilization

Advantages of Gamma Ray Sterilization 

  1. Ease of Operation – Irradiation technology is the simplest and most reliable sterilization method, as it has only one variable: exposure time. This is the easiest variable to control (compared to other processes which have several variables, such as time, pressure, temperature, moisture, and gaseous concentration). 
     

  2. Simple Validation Process – Validation for radiation sterilization is simpler and cheaper than other methods. This process has been recognized and favorable by international regulatory bodies for decades.
     

  3. Reliability – The irradiation process is more reliable than alternative sterilization methods, as the source of the gamma rays is an isotope, which emits predictable and known radiation doses.
     

  4. Product is Treated in its Final Packaging – The product is placed in its final packaging prior to sterilization, thus avoiding any possibility of re-contamination due to handling after sterilization. The process does not involve opening or interfering with the contents of the package in any way. 
     

  5. Cold Process – Heating is not required during the neutralization of microorganisms. This feature even allows for sterilization of products that are sensitive to heat, including products containing ice. 
     

  6. No Residue – After treatment, products do not become radioactive, and there are no gaseous or toxic chemical residues, in contrast to chemical sterilization using toxic ethylene oxide, which results in the sterilized product containing gaseous or toxic chemical residues.
     

  7. No Moisture – In this process, no moisture is introduced that would normally affect the product and its packaging.  
     

  8. Penetrability – The gamma rays' ability to deeply penetrate a product ensures that the entire volume of the product is exposed to the radiation treatment. It is not dependent on heat convection or gas diffusion, as in alternative methods. This advantage permits irradiation of all types of containers and does not require special packaging. 
     

  9. Immediate Use – The product can be used immediately following sterilization (as opposed to processes involving ethylene oxide, following which the product must remain in isolation for a period of time, which increases the overall duration of the sterilization process). 
     

  10. This irradiation process is approved by all global health authorities. 

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