Clinics and physicians rely on manufacturers to ensure drug efficacy of active pharmaceutical ingredients (APIs) and sterility assurance across the supply chain—for the health and safety of their patients. As a manufacturer, we understand that your choice of sterilization modality is unique. Enhancing the aseptic manufacture sterility assurance level (SAL) of pharmaceuticals without affecting drug efficacy is a critical requirement of terminal sterilization.
As pharmaceutical delivery has evolved, so have sterilization requirements. With the increase in drug-device combinations—like stents coated with a pharmaceutical preparation—sterilization processes must deliver a SAL of 10-6 without impairing the drug efficacy.
Your products are cutting edge. So too are our approaches to pharmaceutical sterilization. Our advanced technology, dosimetry methods, and processing capabilities make it possible to sterilize devices while ensuring the safety and stability of your pharmaceutical and biologic products.
With decades of sterilization expertise, Sterigenics offers choice of modality.
Applications for sterilization of pharmaceuticals using radiation-based Gamma
- Irradiation of ambient and frozen tissues
- Nonproliferation by irradiation to stop cell growth in vaccine production
- Decontamination of bio-hazard type products; for example, human serum
- Virus removal from blood, serums, or other biologic products; for example, frozen products that require irradiation under cold chain management
- Sterilization or decontamination of bulk APIs, excipients, or ingredients
- Sterilization of drug-device products
- Sterilization of hydrogels
- Final sterilization of pharmaceutical products; for example, API-filled vials or syringes, which can be powder-filled, solution or suspension, gel or ointment