5 Tips Of Sterilization With Gamma Irradiation

 Geometry, material composition, and structure all influence whether a sterilizing technology will work for your product. The device's construction involves various plastics, stainless steel, and adhesives to hold the components together for a disposable design featuring long, small diameter tubing that makes touch with a medicinal agent.

In gamma irradiation sterilization, the product is exposed to a radiation source, usually, Cobalt 60 isotope, which decomposes into Nickel 60 isotope and emits gamma rays in the process. These gamma rays can penetrate the entire product, rendering any germs present inactive.

Several steps are required to take your product, from early-stage development to certified sterility. Below are five tips for preparing your product for gamma irradiation sterilization in Gamma Irradiation Facilities in India.

Engage Early  

Reaching out earlier enables service providers to offer advice, make recommendations, and assist you in designing your product for irradiation. Gamma irradiation sterilization is an exercise with a detailed and complicated process. These materials will help you become more familiar with the language and the validation process for sterilization.

Determine your Maximum Dose

 Gamma radiation is administered as a dose measured in kilo-Grays, and each of its dose has a tolerance and range associated with it. For example, the radiation delivered measured on the product may range from 35 to 45 kGy to achieve a sterilization dose of 35 kGy. If the product starts to disintegrate at or around 45 kGy, the administered dose must be reduced, resulting in an amount that is too low to achieve sterility.

The irradiated product must withstand a high enough maximum dose that the minimum dose required to render the product sterile within a manageable range. To ensure suitable sterilization (or minimum dose, the maximum dose should generally be 45-50 kg or higher. Although a lower maximum dose may be possible, alternative and more costly methods of determining the sterilization dose may be required later in the simple.

Lockdown Your Design 

The product supply chain,  design, and manufacturing process all affects how the product is sterilized. Even changing your raw material supplier can affect the level of bioburden (the number of living microorganisms present on the product). If the bioburden changes, so do the required sterilization dose, requiring revalidation and increasing your costs.

Create a Plan

Gamma Irradiation Facilities in India will undoubtedly be interested in how you plan to process your device for sterility when seeking regulatory approval to sell it. For example, you must be able to describe the sterilization method – and, in the case of gamma irradiation, the radiation dose; the strategy or plan for validating the sterilization cycle (the VDmax25 method is preferred due to the reduced statistical sample requirements); and the sterility assurance level that is approximately 10-6 or a 1 in 1 million sterility assurance level).

Execute

It is time to get started! Your product's design is finished, the materials are locked down, and production is ramping up: you are almost ready to sell. The first units of the line (or pre-production units are ideal candidates for sterilization validation. The number of units needed for Gamma Irradiation Facilities in India will vary depending on the product's size, complexity, and validation method. The team estimated that 80-100 units would be consumed for the tubing-based product, including the radiation dosing, analytical chemistry, and long-term shelf life testing that are all part of a sterilization validation program.