Navigating Shipping Studies
Shipping studies play a crucial role in the stability testing process within the pharmaceutical and biotechnology industries. These studies are specifically designed to assess how transportation affects the quality, safety, and efficacy of drug substances and products. By exposing samples to various environmental conditions like temperature, pressure, and humidity changes, shipping studies evaluate their stability over time.
The insights gained from these studies are invaluable for manufacturers to ensure that their products maintain the integrity throughout transport and storage. Additionally, the data from shipping studies are instrumental for regulatory agencies in evaluating new drug products.
If you’re seeking expert guidance in designing a shipping study tailored to your CCIT needs, Gateway Analytical is here to help. Our expertise in conducting comprehensive shipping studies ensures that your pharmaceutical products are reliably protected throughout their transport and storage lifecycle. Contact us to learn how we can assist in safeguarding the integrity and efficacy of your products during shipping.
Gateway’s Path to Safety & Stability
Container Closure Integrity Testing (CCIT) shipping studies are a specialized subset of shipping studies in the pharmaceutical and biotechnology industries. They focus on evaluating the integrity of drug product packaging during transportation. These studies are vital for protecting products from external contaminants and maintaining their quality, safety, and efficacy in transit. In CCIT shipping studies, drug product containers are subjected to various environmental stressors, such as temperature and pressure fluctuations.
