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In the field of pharmaceutical manufacturing, sterilization is a critical process to ensure the safety and efficacy of pharmaceutical products. Irradiation sterilization services employ high-energy radiation, such as electron beams, gamma rays, or X-rays, to eliminate microbial contaminants that can compromise the quality of pharmaceutical goods. This method is especially suitable for products that are sensitive to heat or moisture, as irradiation can be carried out at ambient temperatures without the need for moisture. The technology offers a high degree of sterility assurance, and its application ranges from the sterilization of solid dosage forms, such as pills and capsules, to advanced biologic and tissue products.
Irradiation sterilization is a key offering within the suite of services provided to pharmaceutical companies that outsource parts of their manufacturing and quality assurance processes. The demand for these services typically correlates with the levels of innovation in drug development, adherence to stringent regulatory standards, and the necessity for rapid and reliable sterilization methods that do not compromise product integrity.
Leading companies that offer irradiation sterilization services include Steris plc, Sotera Health (parent company of Nelson Labs, Nordion, and Sterigenics), Sterigen Ireland Ltd, Synergy Health plc, Midwest Sterilization Corporation, and Steri-Tek. These companies provide comprehensive sterilization solutions tailored for the pharmaceutical industry, incorporating state-of-the-art technology and adhering to strict regulatory compliance. Show Less Read more