Radiation Sterilization of Parenterals
Sterilization in the pharmaceutical and medtech industry is vital to providing the most potent and safest product to patients. As the industry becomes more advanced, the sterilization processes must meet demand, this is especially true for parenteral preparations, as they are infused or implanted into patients.
The process of sterilization in the manufacturing of parenterals must result in a minimal amount of degradation. To prepare for this, pharmaceutical manufacturers must ensure that each compound is stable after being irradiated. This is particularly important when the compound is part of a formulated medication, as the compound may change when irradiated along other compounds.
Ensuring that the correct radiation dose is used for sterilization is critical. Any digression from that dose could damage or diminish the sterility of the product. The radiation dose is determined by the bioburden, which is the pre-sterilization microbial contamination, and the necessary Sterility Assurance Level (SAL) of the product, By abiding by that guideline, it can be assured that the final product is delivered at full potency while maintaining sterilization standards.
There are several methods of parenteral sterilization that are approved by the FDA and also meet ISO and USP standards. One such, offered by Steri-Tek, is X-Ray. X-Ray sterilization provides one of the fastest processing times. It also offers a Dose Uniformity Ratio (DUR) which allows for tight dose ranges, which is vital in parenterals as well as other pharmaceuticals. By meeting the exact dose required and processing in a tight dose range, Steri-Tek can consistently and accurately meet all standards put in place to ensure deliverability of a safe and effective final product.