Often described as the driving force of pharmaceutical industry, biologic drugs have the ability to address chronic diseases, unmet medical needs and comprise of more than half of the drugs in development. These are generally large complex molecules, derived from human, animal, or microorganisms through biotechnology. Examples include blood components, cells, vaccines, tissues, and recombinant proteins. The ability of biological drugs to treat life threatening diseases coupled with aging population has lead to tremendous growth in the global biological drugs market. However, the rapid growth of biological products has also increased packaging challenges to deliver safe and effective products.
Drug contamination is a serious concern in any medical industry; however, for biologics, it amplifies several folds because they are used to treat serious illnesses and chronic conditions. Contamination has a direct impact on product stability resulting in reduced shelf life and efficacy. Along with maintaining an acceptable shelf-life, there are other challenges too. Another important factor that can affect the quality of a drug is environmental conditions. For example, if a product is exposed to extreme temperature during transit, the product quality may be compromised. A biologic can also lose its stability if it’s unable to withstand variations in light and chemicals that it might encounter. Therefore, in order to cover packaging challenges associated with biological products, ensuring its container closure integrity is crucial.
Ensuring package integrity with PTI’s MicroCurrent HVLD technology
PTI’s MicroCurrent HVLD technology is a non-destructive, non-invasive container closure integrity test (CCIT) method that is found to be highly effective across applications such as pre-filled syringes, vials, cartridges, ampoules, BFS, bottles and pouches. This technique can precisely detect any leak in a wide range of liquid-filled products including extremely low conductivity sterile water for injection (WFI) and proteinaceous products with suspensions. Under this method, the sealed container is scanned using electrode probes to detect the presence of any leak. Defects in the container as well as its approximate location can be identified by analyzing a change in the current flow. MicroCurrent HVLD technology utilizes about 50% less voltage and exposes the product and environment to less than 5% of the voltage when compared to conventional HVLD solutions. It is one of the most effective CCI technologies for all parenteral and biologic products.
Benefits of PTI’s MicroCurrent HVLD technology
- Non-destructive, non-invasive, no sample preparation
- Highly effective across all parenteral products, including extremely low conductivity liquids (WFI)
- Ensure higher levels of accuracy and reliability in results
- Offline and 100% online inspection at high production speeds
- Simplifies the inspection and validation process
- Referenced in USP 1207 Guideline
Microcurrent HVLD, CCI, container closure integrity, container closure integrity testing, Integrity of biologic products