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, firstname.lastname@example.org
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