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Gamma rays are a form of electromagnetic radiation—like x-rays, but with higher energy. The primary industrial sources of gamma rays are radionuclide elements such as Cobalt 60, which emit gamma rays during radioactive decay. Gamma rays pass readily through plastics, rubber, metal and various other materials and kill bacteria by breaking the covalent bonds of bacterial DNA.

Understanding Gamma Sterilization

Gamma irradiation provides a number of benefits in cost and sterility assurance. It can be applied under safe, well-defined, and controlled operating parameters, and is not a heat, pressure or moisture generating process. Consequently, there is no heat stress and condensate drainage or outgassing is not required. Most importantly, there is no residual radioactivity after irradiation. Microorganisms are inactivated by damage to their nucleic acids resulting from this ionizing irradiation. Product is immediately ready to use upon completion of gamma radiation cycle.

Below are the 5 tips for preparing your product for gamma irradiation sterilization in ongoing production:

1.  Proper Dose Calculation:

The first and most important step in gamma irradiation sterilization is to calculate the appropriate dose of gamma radiation. The dose should be determined based on the type of material being sterilized, the packaging, and the desired level of sterility.
Under-dosing can lead to ineffective sterilization, while over-dosing can cause
damage to the material. Therefore, it is essential to have a clear understanding of the material’s properties to determine the optimal dose. Hence for all new products Doing a Dose Establishment study for their products is a must and we at AKSHAR GAMMA STERILES LLP provide a complete solution from our partners laboratories to make and establish a complete Dose Establishment procedures and conduct the study for dose Setting of a new product.

2.  Material Preparation:

The materials to be sterilized must be prepared properly before irradiation. This can
involve cleaning the material to remove any dirt or debris, removing any excess
moisture, and ensuring that the packaging is suitable for irradiation. Any packaging
used should be able to withstand the radiation dose and prevent any cross-
contamination during transportation. All the product must be completely sealed using appropriate materials with no rupture, puncture in the packaging. Also, even
distribution of material inside boxes / shippers and adequate equal filling of shippers is also important factor to consider.

3.  Radiation Source Selection:

The selection of a radiation source is crucial. The radiation source should be selected based on the type of material to be sterilized and the desired level of sterility. Cobalt-60 is a common gamma radiation source used for sterilization. The source needs to be reliable and produce the desired dose rate consistently. The irradiation facility should also have a comprehensive quality control program to ensure the effectiveness of the sterilization process. Currently Cobalt–60 is widely used source for industrial gamma sterilization and other options as Cesium 137.

4.  Dose Mapping:

Dose mapping is a process that involves measuring the amount of radiation
absorbed by a material during irradiation and also helps to confirm the minimum and maximum dose delivery in any gamma irradiation system or plant. This process helps ensure that the appropriate dose is delivered uniformly to all parts of the material. It is important to perform dose mapping to ensure that the sterilization process is effective and that the material meets the required sterility assurance level (SAL). Dose mapping should be carried out every time when a new gamma facility is used and every time the existing gamma facility upgrades or modifies the source strength.

5.  Sterility Testing:

Once the Verification Dose has been applied, the product samples will be routed
back to the microbiology laboratory to perform a sterility test at primary
manufacturers facility. The sterility test will confirm whether all viable microbes
present on the product sample achieved lethality to deem the process successful.

6.  Post-Sterilization Handling:

After sterilization, the material must be handled carefully to prevent contamination.
Proper handling includes maintaining a sterile environment, using appropriate
equipment, appropriate packaging and following appropriate procedures for
transportation and storage. Any material that has been irradiated must be labeled to
indicate that it has been sterilized and to provide the date of irradiation and the dose
used.

Conclusion

In conclusion, gamma irradiation sterilization is an effective method of sterilization that requires careful planning and execution to ensure that the material is sterilized effectively. Proper dose calculation, Dose setting, material preparation and packaging, radiation source selection, dose mapping validation, and post-sterilization handling are essential steps in achieving successful gamma irradiation sterilization. Adhering to these tips will help to ensure that the material remains sterile and is safe for use.