Suitability-for-Use Considerations for Prefilled Syringes - Pharmaceutical Technology

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Suitability-for-Use Considerations for Prefilled Syringes
The nature of their application and their mode of use mean that prefilled syringes meet the regulatory definitions of immediate packaging or container–closure systems.

Pharmaceutical Technology

Closing observation

The issue of suitability for use of container–closure systems in general and prefilled syringes in particular is complex and multidimensional. This is especially true for prefilled syringes, because of the nature of the syringe system and the functional sensitivity of the biopharmaceutical products that are the most significant potential market for these systems. A high degree of diligence must be used when examining the product quality and safety aspects of drug product–container closure compatibility. Given the complexity of establishing suitability for use, it is clear that no single approach or method is adequate and that an effective and efficient suitability-for-use assessment requires the use of multiple and orthogonal strategies and tactics.

Dennis Jenke is a senior research scientist at Baxter Healthcare Corporation, Technology Resources Division, 25212 W. Illinois Route 120, Round Lake, IL 60073, tel. 847.270.5821, fax 847.270.5897,


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