Closures for Pharmaceutical Preparations: A Review of Design and Test Considerations - The author examines the use of closures for products intended for injection. - BioPharm International

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Closures for Pharmaceutical Preparations: A Review of Design and Test Considerations
The author examines the use of closures for products intended for injection.


BioPharm International
Volume 25, Issue 12, pp. 32-36

REFERENCES

1. L. Solomun et al., J. Pharm. Biomed. Anal. 48 (3), 744–8 (2008).

2. W. Curry et al., AAPS PharmSciTech. 11 (4), 1572–9 (2010).

3. USP 32–NF 27 (Rockville, MD, 2009), pp. 4133–4140 .

4. E.J. Smith and R.J. Nash, "Elastomeric Closures for Parenterals," in Pharmaceutical Dosage Forms: Parenteral Medications, K.E. Avis, H.A. Lieberman, L. Lachman Eds. (Marcel Dekker, New York, 1st ed., 1992), pp. 445–507.

5. G.D. Chanana, X. Guo, K.E. Avis, et al., J. Parenter. Sci. Technol. 47 (1), 22–5 (1993).

6. I. Markovic, Am. Pharm. Rev. 9 (6), 20-27 (2006).

7. D.R. Jenke, PDA J. Pharm. Sci. Technol. 59 (4), 265–281 (2005)

8. FDA Container and Closure Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products, (Rockville, MD, Feb. 2008).

9. L.S. Burrell, M.W. Carver, G.E. DeMuth, and W.J. Lambert, PDA J, Pharm. Sci. Technol. 54 (6), 449–55 (2000).

10. E. Kirsch et al., PDA J, Pharm. Sci. Technol. 51 (5), 195–202 (1997).

11. P. Kiang et al., J. Parenter. Sci. Technol. 46 (S2) (1992).


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