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,


1. D.E. Overcashier, E.K. Chan, and C.C. Hsu, "Technical Considerations in the Development of Prefilled Syringes for Protein Products," Am. Pharm. Rev. 9 (7), 77–83 (2006).

2. M.N. Eakins, "The Design and Construction of Prefilled Syringes", Am. Pharm. Rev. 10 (6), 47–51 (2007).

3. B. Harrison and M. Rios, "Big Shot: Developments in Prefilled Syringes," Pharm. Technol. 30 (5), 42–48 (2007).

4. Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics (US Department of Health and Human Services, Food and Drug Administration, Rockville, MD, May, 1999).

5. Guideline on Plastic Immediate Packaging Materials (European Medicines Agency, CPMP/QWWP/4359/03, EMEA/CVMP/205/04, May, 2005).

6. D. Jenke, "Evaluation of the Chemical Compatibility of Plastic Contact Materials and Pharmaceutical Products; Safety Consideration related to Extractables and Leachables," J. Pharm. Sci. 96 (10), 2566–2581 (2007).

7. M.J. Akers, S.L. Nail, and W. Saffell-Chamber, "Top Ten Hot Topics in Parenteral Science and Technology," PDA J. Pharm. Sci. Technol. 61 (5), 337–361 (2007).

8. K. Nicholas, "Extractables and Leachables Determination: A Systematic Approach to Select and Qualify a Container Closure System For a Pharmaceutical Product," Am. Pharm. Rev. 9 (3), 21–27 (2006).

9. I. Markovic. "Evaluation of Safety and Quality Impact of Extractable and Leachable Substances in Therapeutic Biologic Protein Products: A Risk-Based Perspective," Expert Opin. Drug. Saf. 6 (5), 487–491 (2007).

10. D.J. Ball, D.L. Norwood, and L. Nagao, "Utility and Application of Analytical and Safety Thresholds for the Evaluation of Extractables and Leachables in Drug Products," Am. Pharm. Rev. 10 (5), 16–21 (2007).

11. H. Lee et al., "Tungsten Leaching from Prefilled Syringes and Impact on Protein Aggregation," poster presented at the PDA Extractables/Leachables Forum, Confronting Extractables and Leachables Issues in an Evolving Industry, Bethesda, Maryland, November 6–8, 2007.

12. R.E. Osterberg, "Potential Toxicity of Extractables and Leachables in Drug Products," Am. Pharm. Rev. 8 (2), 64–67 (2005).


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