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Research ArticleRESEARCH ARTICLE

Development of a Dye Ingress Method to Assess Container-Closure Integrity: Correlation to Microbial Ingress

Lana S. Burrell, Mary W. Carver, George E. DeMuth and William J. Lambert
PDA Journal of Pharmaceutical Science and Technology November 2000, 54 (6) 449-455;
Lana S. Burrell
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  • For correspondence: lana_burrell@eisai.com
Mary W. Carver
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George E. DeMuth
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William J. Lambert
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Abstract

To demonstrate maintenance of parenteral product sterility, container-closure integrity over the shelf life of the product is critical. In the past, sterility testing has been used to ensure closure integrity. However, because of the limitations associated with sterility testing, there is a need for an improved method for evaluating containerclosure integrity. This article describes the development of a physical test method (dye ingress) for the evaluation of container-closure integrity. FD&C Red No. 40 dye was used in dye ingress studies. The dye solution visual detection limit was similar to the spectophotometric detection limit. This limit was approximately 0.0025 μL of dye/mL, which corresponds to an absorbance of approximately 0.002 absorbance units at 506 nm. Breached vials with various sizes of microtubes were utilized to correlate the dye ingress method with a microbial ingress method. The inner diameter of the microtubes ranged from 2 to 75 μm. The dye ingress and microbial ingress methods had similar sensitivity to breached vials. One advantage of the dye method over microbial ingress is that it may be utilized with vials containing formulations that are cidal or static to microbes. Thus, the dye ingress method is considered an excellent test method for evaluating container-closure integrity.

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PDA Journal of Pharmaceutical Science and Technology
Vol. 54, Issue 6
November/December 2000
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Development of a Dye Ingress Method to Assess Container-Closure Integrity: Correlation to Microbial Ingress
Lana S. Burrell, Mary W. Carver, George E. DeMuth, William J. Lambert
PDA Journal of Pharmaceutical Science and Technology Nov 2000, 54 (6) 449-455;

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Development of a Dye Ingress Method to Assess Container-Closure Integrity: Correlation to Microbial Ingress
Lana S. Burrell, Mary W. Carver, George E. DeMuth, William J. Lambert
PDA Journal of Pharmaceutical Science and Technology Nov 2000, 54 (6) 449-455;
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Cited By...

  • Single-Use System Integrity I: Using a Microbial Ingress Test Method to Determine the Maximum Allowable Leakage Limit (MALL)
  • Comparing Physical Container Closure Integrity Test Methods and Artificial Leak Methodologies
  • Method Development for Container Closure Integrity Evaluation via Headspace Gas Ingress by Using Frequency Modulation Spectroscopy
  • Container Closure Integrity Testing--Practical Aspects and Approaches in the Pharmaceutical Industry
  • Artificial Leaks in Container Closure Integrity Testing: Nonlinear Finite Element Simulation of Aperture Size Originated by a Copper Wire Sandwiched between the Stopper and the Glass Vial
  • Feasibility of Using Fluorescence Spectrophotometry to Develop a Sensitive Dye Immersion Method for Container Closure Integrity Testing of Prefilled Syringes
  • Mass Extraction Container Closure Integrity Physical Testing Method Development for Parenteral Container Closure Systems
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