Container closure integrity (CCI) testing has been steadily moving up the pharmaceutical manufacturing agenda for some years now.
The latest research shows that it’s not just ampoules that are prone to CCI defects. Other primary packaging types such as vials, cartridges and syringes require equally thorough testing, especially when filled with lyophilised products. Consequently, the United States Pharmacopeia (USP) has revised its General Chapter 1207, calling for more quantitative, validated CCI test methods. A significant shift is expected towards non-destructive technologies.
CCI defects might be highly hazardous to patients if not detected prior to administration. In fact, they can be even more dangerous than particles contained in pharmaceutical liquids, as they might lead to a change in the active pharmaceutical ingredient (API).
As a result, drugs can lose their efficacy or lead to unexpected side-effects. In terms of stability, CCI issues could result in oxidation, hydrolysis or loss of vacuum, and have a significant impact on the drug’s effectiveness and shelf-life.
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