E-Beam sterilization
Procedure with handicap or insider tip
Introduction
Sterilization of products is essential in many industries, whether in medical technology, the food industry, or pharmaceutical production. Classic methods such as steam or ethylene oxide have proven themselves, but they also have disadvantages. E-Beam technology offers a modern and particularly clean alternative—an innovative sterilization process using electron beams. This article is about how the technology works, its advantages, and specific areas of application.
The sterilization method has a small market share, but does not require toxic or radioactive materials compared to the "big players" ethylene oxide and gamma radiation. E-Beam is also significantly more energy efficient than steam sterilization in terms of the energy required per mass of sterile goods.
What is e-Beam sterilization?
E-Beam stands for “electron beam”. This method uses high-energy electrons generated by a linear accelerator. The energy transmitted by the radiation destroys molecular structures and breaks down microbial bonds, thereby eliminating any germs present.
Ablauf einer e-beam Sterilisation
Irradiation usually takes place via a conveyor belt that transports the products past the beam at a constant speed. Dosage: The applied radiation dose is measured in kGy (kiloGray). Typical sterilization doses are between 25 and 50 kGy.
- Dosimetry: Dosimeters are used to monitor the dose.
- Shielding: Although e-Beam does not use a radioactive source, the plant environment must be protected against radiation leakage by metal plates and concrete enclosures.
- Safety: The beam can be switched off at any time.
Sterilization validation according to the VDmax method
Sterilization validation in ISO 11137 follows the methods also described for gamma sterilization.
A VDmax method must correspond to the specified bioburden in the standard (e.g., for VDmax25, the bioburden must be ≤ 1,000 CFU/product).
1. Determination of the bioburden
VDmax25 may only be used if the average bioburden is ≤ 1,000 CFU/product.
- Selection of at least 10 products from 3 independent, representative production batches. Bioburden determination is carried out in accordance with ISO 11737-1.
- Calculation of the average bioburden value from the 30 samples (not just the mean value from 3 batches!).
- The sterilization dose is selected on the basis of this value. Selection of at least 10 products from 3 independent, representative production batches each.
2. Determination of the verification dose
- The verification dose is determined in accordance with Table 9 of ISO 11137-2 (dose in kGy) based on the mean bioburden and the targeted SAL of 10⁻⁶.
3. Conducting the verification dose experiment
- Selection of 10 representative products from a typical batch.
- Products are irradiated with the determined verification dose (not with VDmax!).
- It must be documented that the dose was ±10% of the target verification dose.
- After irradiation, sterility testing is performed in accordance with ISO 11737-2.
- If 2 samples are non-sterile, a new verification dose test is performed with different data or switch to procedure 1.Criterion: max. 1 of 10 tested products may be non-sterile
Market situation
Despite its advantages, the method is less widespread at present because it has lower radiation penetration and requires high investment and technical expertise.
E-beam sterilization is becoming increasingly important as an alternative to less sustainable methods, particularly due to its short process times and more sustainable technology. This trend can be observed in Europe. New facilities with higher capacity are being built, some of them as in-house solutions for medical device manufacturers. Overall, there is growing market interest, particularly for smaller, sensitive products and high-volume standard items.
Conclusion
eBeam is a modern and powerful sterilization process. It is particularly suitable for sensitive products and impresses with its speed, safety, and environmental friendliness. Despite the investment costs, it is a forward-looking solution for many industries. Those who are already familiar with gamma sterilization can apply much of the same knowledge, especially the validation follows the same principles and procedures and uses the same series of standards of ISO 11137.
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