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At the recent 2018 PDA Parenteral Packaging in Rome, Dr. Qingyu Zeng, Principal Scientist in the Scientific Insights Lab in Scientific Affairs & Technical Services, gave a presentation entitled Critical Time- & Temperature- Dependent Container Closure Integrity (CCI) Through the Sealed Drug Product Life Cycle. This presentation gave an update on research that aims to provide fresh insights to the parenteral packaging industry.
By employing both testing evaluation and modeling calculations, research results demonstrate that container closure sealing performance has a critical nature of both time- and temperature-dependency. Discussion included how to develop a systematic approach to proactively and practically consider: design, set up, control, and management of stopper sealing performance. In addition, cosmetic vial assembly acceptance through proper considerations in container closure system (CCS) and capping processes was discussed. These techniques are intended for the purpose of ensuring sufficient sealing performance throughout the entire sealed product life cycle.
Vaccines have helped reduce the instance of infectious diseases around the globe, nearly eradicating past plagues, such as smallpox and polio. A very effective method of delivery is intradermal (ID) injection – now made easier with two novel products on the market.
The pharmaceutical industry is shifting toward pre-filled syringes (PFS) as the optimal delivery system for many drug products. The utility of a syringe system is dependent upon its ability to maintain good container closure integrity (CCI) through drug product shelf life.<br />
Particles in parenteral drug products are a serious concern; they can cause issues such as product recalls, or worse, immunogenic responses. Sources of particles are varied; they can be from aggregates of biologic API’s, excipient contaminants, components, or silicone oil used to promote syringe function. With emphasis on safe and efficient delivery of drug products, West is focused on strategies to both measure particles, and mitigate their presence.
Recently, there has been increased scrutiny from regulatory authorities to quantify and qualify subvisible particles in biopharmaceutical products. Such particles, which can cause a protein to denature, are of concern to pharmaceutical manufacturers since they can affect the efficacy of the drug product. As regulatory bodies continue to raise the bar on quality, industry is looking for “zero defect” and particle free components as well as a way to minimize quality variation.
Selecting the right package for a drug product is essential. To do this, it is necessary to understand the surface chemistry of the components of the package to determine if any unwanted interaction with the drug product is likely.
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