Solutions For Injectables And Parenteral Formulations

The regulatory landscape has been evolving with increased demands from regulatory agencies to improve patient safety.

Mitigating Risk for Injectable and Parenteral Formulations

High-risk products must be sterile and essentially free from endotoxins. A manufacturer cannot rely only on terminal sterilization processes or quality control testing to assure that these requirements are met. Key considerations for high-risk application include:

• Minimizing the risk throughout the process to yield a safe product.
• Using high-quality, low-in-bioburden raw materials as bioburden has to be in line with the capabilities of the selected sterilization method.
• Using raw materials low in endotoxins for improved patient safety.