Pharmaceutical container/closure integrity I: Mass spectrometry-based helium leak rate detection for rubber-stoppered glass vials

PDA Journal of Pharmaceutical Science and Technology

Volumn 51, Issue 5, 1997, Pages 187-194

  Kirsch, Lee E ^a,b   Nguyen, Lida ^a   Moeckly, Craig S ^a  

^a UNIVERSITY OF IOWA   (United States)

^b 118 Pharmacy Building ^*  (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EPOXIDE; GLASS; HELIUM; RUBBER; TRACER;

AMBIENT AIR; ARTICLE; CONTAINER; CONTROLLED STUDY; GAS FLOW; GAS PERMEABILITY; MASS SPECTROMETRY; PHARMACEUTICS; PRESSURE;

DRUG PACKAGING; GLASS; HELIUM; MASS SPECTROMETRY;

EID: 0030657646     PISSN: 1076397X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (7)

1. "Guidance for Industry for the Submission of Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products," FDA guideline 11/94
2. Dana K. Morton, "Container/closure integrity of parenteral vials," Journal of Parenteral Science & Technology, 41:145 (1987).
3. PDA Newsletter, 31(2):16 (1995).
4. Introduction of Helium Mass Spectrometer Leak Detection. Varian Associates, Palo Alto, 1980, pp. 21-22 and 67-70.
5. Nondestructive Testing Handbook, Volume 1, R. C. McMaster, editor, ASNT, USA, 1982, pp. 89-99 and 730.
6. Gary E. Greene, "Warehousing of pharmaceutical closures," Bulletin of the Parenteral Drug Association, 31:103 (1977).
7. Personal communication, Jack Handy, World Precision Instruments