Sterilization by irradiation: let’s clarify some doubts

“Can you provide us with Aluminium tubes already sterilized?”

As pharmaceutical packaging manufacturers, we hear this question often! In recent months, even more often than usual: there is an increasing demand for sterilized tubes, which leads companies to have to organize themselves effectively, with reliable partners, in order to ensure business continuity and product distribution. Indeed, the possibility exists for our clients to obtain tubes that are already sterilized and ready for filling in a clean room. But it is worth clarifying a few points, which too often remain vague. Starting with the basic concept: what, really, does “gamma-irradiation” mean?

Gamma irradiation procedure: what does it consist of?

There are various methods of sterilization. The irradiation method involves controlled exposure of the object to be sterilized to a radioactive source, which emits beta rays, X-rays, or gamma rays. Radiation penetrates deep inside matter: gamma rays, in particular, have more effective penetration than even X-rays and beta rays, since they are able to penetrate a dense material such as Aluminium and thus eliminate all microbial life. Sterilization by Gamma radiation is therefore particularly suitable for packaging intended for pharmaceutical products, to completely remove even the slightest risk of bacterial contamination.

The role of Tubettificio Perfektüp

Tubettificio Perfektüp does not deal directly with sterilization, but offers consultative support for the sanitization and sterilization procedure required by clients, particularly those in the pharmaceutical sector. In fact, the sterilization procedure, in order to be validated, must be activated by the end client according to ISO:11137 /1, which specifies requirements for the sterilization of medical devices by radiation. But we know how torturous the bureaucratic aspects of this path can be, so much so that even the Quality departments of top pharmaceutical companies are challenged. That’s why we offer to support our Pharma clients in all aspects of secondary packaging and logistics of this process, and in particular in the definition of secondary packaging, which can be very complex depending on individual needs. We can provide different types of secondary packaging: for example, double or triple bagging of the single box or groups of boxes, boxes of different materials and different types of bagging, so that we can meet every client’s needs

In addition, Tubettificio Perfektüp can facilitate the gamma irradiation procedure by putting the client in touch with the company Sterigenics, among the few in Italy and Europe to provide this service. It will then be up to the client to decide how to proceed, establishing a direct relationship with Sterigenics, based on the requirements of the country of reference, the sterility levels of the production environments in which packaging will take place, and the specifications of the pharmaceutical product. 

Sterigenics also offers the alternative of X-ray sterilization for companies that request it, a procedure that is in any case effective and in many cases can be perfectly adapted to the company’s needs (think of the world of cosmetics or food). 

Aluminium tubes sterilized by gamma rays: the procedure

The process of gamma irradiation of pharmaceutical packaging is very simple. Here are the basic steps of the procedure:

  1. Tubes’ Preparation:
    • The tubes are placed in special boxes, which are in turn placed in a double (but also triple, quadruple) plastic bag. Everything is stored in cardboard boxes, which are then placed on pallets.
    • Each individual box is labeled with a gamma-sensitive adhesive, which changes color when exposed to the rays and aids visual identification of packages that have already been treated.
  2. Transport and Irradiation:
    • The pallets are transported to a protected radiation path via a freight elevator.
    • The irradiation area is a structure with very thick, leaded walls, designed as a maze to ensure the safety and effectiveness of the procedure.
    • At the center of the structure is a cobalt source that emits gamma rays.
  3. Irradiation Process:
    • The pallets are placed on a self-propelled hoist that moves them slowly around the cobalt source.
    • Gamma rays penetrate through Aluminium and other materials, eliminating all microorganisms inside the tubes.
  4. Control and Validation:
    • Process validation is carried out by the client according to ISO 11137-1, which specifies requirements for sterilization of medical devices by radiation.

Alternative to gamma irradiation: ethylene oxide.

An alternative method of sterilization is ethylene oxide, a gas commonly used for sterilizing surgical instruments. A method that is undoubtedly scientifically valid and used successfully in many contexts. However, we believe that gamma irradiation is preferable for pharmaceutical packaging, as the use of ethylene oxide presents several practical issues:

  • Process Complexity: Requires the use of protective bags and a post-processing decontamination step.
  • Cost: The process is generally more expensive than gamma irradiation.

In addition, ethylene oxide is a potentially toxic gas, so the entire procedure requires extreme care and caution, no less than that required by gamma irradiation. 

Pharmaceutical packaging: gamma irradiation is the most effective sterilization procedure

Gamma sterilization is effective, safe and universally recognized. With Tubettificio Perfektüp by their side, pharmaceutical companies can count on the highest quality of result and expert advice throughout the whole procedure.

Contact us to learn more.

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