All drug products must be sterilized to destroy any potential microbial contaminants such as bacteria, fungi, or viruses to ensure patient safety. Most sterilization is performed under harsh conditions. The selection of an appropriate sterilization method requires an in-depth understanding of the properties of the drug substance, the packaging material, and the characteristics of the final formulated product to ensure safety.
Learn why e-beam terminal sterilization is the preferred method for pharmaceuticals.
Types Of Sterilization Methods
There are many sterilization methods currently on the market, with certain types of drug products and packaging each utilizing different methods of sterilization.
When deciding the right type of sterilization, many factors come into play. During the process of sterilization, products are subject to thermal and mechanical stress and pressure. If these temperatures or stresses are too high, the container can burst, warp, or become porous, then causing the drug product to become unstable.
Some common methods of sterilization include:
- Vacuum Steam - Air is completely evacuated from the pressure chamber and all containers. Good for solid or porous materials or blister-packaged products.
- Steam/Air Mixture - Directly injects steam into the sterilization chamber. This heats the chamber, allowing for subsequent sterilization. Best used for open, semi-sealed, or closed containers.
- Hot Water Shower - An ideal technique if keeping thermal stress to a minimum is required. Suitable for liquids in closed containers.
Electronic Beam Terminal Sterilization - Preferred For Drug Products
Terminal sterilization is the preferred method for drug products because, in this process, sterilization takes place after the product has been filled into the primary packaging. Because of this, there are no further opportunities for contamination due to human intervention.
At MediZap, we strive for innovation and are truly proud of our proprietary and effective e-beam sterilization method for terminal sterilization of all drug products. This type of sterilization eliminates the temperature and mechanical stressors of other sterilization methods, and is one of the key reasons why compounding pharmacies and pharmaceutical companies trust their products to this process.
MediZap's electron-beam processing, or electron irradiation, is the most advanced sterilization technology on the market. This technique uses beta radiation - a form of high-energy electrons - to penetrate and disrupt the microorganism’s RNA/DNA chains (their genetic material and means of survival). Electron beam provides the highest level of sterility assurance at 10⁻⁶. When these chains are disrupted, the microorganism can no longer survive and eliminates any risk of contamination.
Because of the nature of e-beam processing, the time to sterilize is also significantly shortened, making the process less stressful on the product and packaging and ensuring its potency and structure remain intact. Additionally, e-beam terminal sterilization meets all ISO regulations, so its use is widely accepted and known for exceptional quality and consistent results.
MediZap is proud to have this innovative technique in place, and we are ready to help you with the terminal sterilization of all of your pharmaceutical needs. Contact us to learn more!