Visualization techniques for assessing design factors that affect the interaction between pharmaceutical vials and stoppers

PDA Journal of Pharmaceutical Science and Technology

Volumn 64, Issue 2, 2010, Pages 182-187

  Lam, Philippe ^a   Stern, Al ^b  

^a GENENTECH INC   (United States)

^b NONE   (United States)

Author keywords

Pharmaceutical stopper; Pharmaceutical vial; Primary package; Sealing surface

Indexed keywords

ARTICLE; DRUG INDUSTRY; FREEZE DRYING; PACKAGING MATERIAL; SCREENING; DRUG PACKAGING; HUMAN; PHARMACEUTICS;

DRUG PACKAGING; HUMANS; TECHNOLOGY, PHARMACEUTICAL;

EID: 78149293970     PISSN: 10797440     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (10)

1. See, for example, the following documents: ISO 8362-1: Injection Containers and Accessories - Part 1: Injection Vials Made of Glass Tubing - 2nd ed.; ISO 8362-2: Injection Containers and Accessories - Part 2: Closure for Injection Vials - 2nd ed.; ISO 8362-4: Injection Containers and Accessories - Part 4: Injection Vials Made of Moulded Glass - 2nd ed.; ISO 8362-5: Injection Containers and Accessories - Part 5: Freeze Drying Closures for Injection Vials - 2nd ed.
2. The DIN documents are identical to the first-edition ISO documents with the same title.
3. See, for example: GPI Glass finish number 2710: Biological Finish.
4. Morton, D. K. Container/closure integrity of parenteral vials. J. Parenter. Sci. Technol. 1987, 41 (5), 145-158.
5. Morton, D. K.; Lordi, N. G.; Ambrosio, T. J. Quantitative and mechanistic measurements of parenteral vial container/closure integrity. Leakage quantitation. J. Parenter. Sci. Technol. 1989, 43 (2), 88-97.
6. Morton, D. K.; Lordi, N. G.; Troutman, L. H.; Ambrosio, T. J. Quantitative and mechanistic measurements of parenteral vial container/closure integrity. Bubble, liquid, and microbial leakage tests. J. Parenter. Sci. Technol. 1989, 43 (3) 104-108.
7. Kirsch, L. E.; Nguyen, L.; Moeckly, C. S. Pharmaceutical container/closure integrity. I: mass spectrometry-based helium leak rate detection for rubber-stoppered glass vials. PDA J. Pharm. Sci. Technol. 1997, 51 (5), 187-194.
8. Kirsch, L. E.; Nguyen, L.; Moeckly, C. S.; Gerth, R. Pharmaceutical container/closure integrity. II: the relationship between microbial ingress and helium leak rate in rubber-stoppered glass vials. PDA J. Pharm. Sci. Technol. 1997, 51 (5), 195-202.
9. Kirsch, L. E.; Nguyen, L.; Gerth, R. Pharmaceutical container/closure integrity. III: validation of the helium leak rate method for rigid pharmaceutical containers. PDA J. Pharm. Sci. Technol. 1997, 51 (5), 203-207. (Pubitemid 27485883)
10. Nguyen, L. T.; Muangsiri, W.; Schiere, R.; Guazzo, D. K.; Kirsch, L. E. Pharmaceutical container/closure integrity. IV: development of an indirect correlation between vacuum decay leak measurement and microbial ingress. PDA J. Pharm. Sci. Technol. 1999, 53 (4), 211-216.