Plastic components

Plastic components

Extractables, Leachables, and Nitrosamines: Where Pharmaceutical Packaging Risk Assessments Commonly Miss Risk

Extractables, Leachables, and Nitrosamines: Where Pharmaceutical Packaging Risk Assessments Commonly Miss Risk

Pharmaceutical packaging systems are designed to protect products throughout manufacturing, storage, transportation, and patient use. As a result, packaging risk assessments have become a routine part of pharmaceutical development and quality management programs. However, one important challenge remains: not all packaging-related risks are immediately visible. While many packaging assessments focus on material compatibility, stability, and […]
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Nitrosamine Risk in Packaging and Storage: The Overlooked Source After Manufacturing

Nitrosamine Risk in Packaging and Storage: The Overlooked Source After Manufacturing

Nitrosamine impurities have become one of the most closely scrutinized classes of pharmaceutical contaminants due to their potential carcinogenic risk and increasing regulatory attention. Following several high-profile product recalls, pharmaceutical manufacturers have implemented extensive risk assessment and testing programs to identify and control potential sources of nitrosamine formation. Most discussions surrounding nitrosamines focus on manufacturing […]
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