Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Experiment Videos

Evaluation of closure integrity after multiple penetrations

G D Chanana1, X Guo, K E Avis

  • 1Department of Pharmaceutics, College of Pharmacy, University of Tennessee, Memphis.

Journal of Parenteral Science and Technology : a Publication of the Parenteral Drug Association
|January 1, 1993
PubMed
Summary
This summary is machine-generated.

Related Concept Videos

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Experiments in the development of a lotion having an acid pH.

American journal of pharmacy and the sciences supporting public health·2010
Same author

Porcine kallikrein gene family: genomic structure, mapping, and differential expression analysis.

Genomics·2007
Same author

Novel animal models for Sjögren's syndrome: expression and transfer of salivary gland dysfunction from regulatory T cell-deficient mice.

Journal of autoimmunity·2007
Same author

Complete nucleotide sequences of Malvastrum yellow mosaic virus and its associated DNA beta molecule.

Archives of virology·2006
Same author

Genetic association study of insulin-like growth factor-I (IGF-I) gene with curve severity and osteopenia in adolescent idiopathic scoliosis.

Studies in health technology and informatics·2006
Same author

Persistent osteopenia in adolescent idiopathic scoliosis--longitudinal monitoring of bone mineral density until skeletal maturity.

Studies in health technology and informatics·2006

This study simulated in-use vial closure testing, finding particle generation increased after 20-30 needle penetrations. Autoclaved closures generally performed better, with leakage only in specific West 850 closures.

Area of Science:

  • Pharmaceutical Science
  • Materials Science
  • Drug Delivery Systems

Background:

  • Multiple dose vials require closures that maintain product integrity after repeated penetrations.
  • Understanding closure performance under simulated use is critical for drug safety and efficacy.
  • Particle generation and leakage are key indicators of closure compromise.

Purpose of the Study:

  • To simulate in-use conditions for vial closures.
  • To determine the maximum number of doses extractable without compromising closure integrity.
  • To evaluate particle generation and leakage from different closure types.

Main Methods:

  • Simulated in-use testing using a modified drill press.
  • Coring test development and evaluation of sterilization effects.

Related Experiment Videos

  • Assessment of particle generation with varying needle gauges (26G, 21G, 18G) and penetrations.
  • Exploratory studies on closure leakage under pressure differentials.

    • Main Results:

    • West 1888 and West 1535 closures generated minimal particles up to 20 penetrations, with a significant increase after 30.
    • Sterilized West 1888 closures showed increased particle generation after 20 insertions (21G, 18G needles).
    • West 1535 closures generated particles after 10 insertions; autoclaved closures produced fewer particles than non-autoclaved.
    • Leakage was exclusively observed in West 850 closures under high-pressure differential conditions.

    Conclusions:

    • Closure integrity, indicated by particle generation, is compromised after a specific number of penetrations (around 20-30).
    • Sterilization methods, particularly autoclaving, can influence particle generation, potentially improving closure performance.
    • West 850 closures exhibit a propensity for leakage under specific pressure conditions, necessitating careful consideration in product formulation and handling.