Method Development for Container Closure Integrity Evaluation via Headspace Gas Ingress by Using Frequency Modulation Spectroscopy | PDA Journal of Pharmaceutical Science and Technology

References

1.↵
U.S. Pharmacopoeia. USP 39 <1207>. Sterile Product Packaging—Integrity Evaluation. United States Pharmacopoeial Convention, Inc.: Rockville, MD, 2016.
2.↵
1. Guazzo D. M.
Container Closure Integrity, Regulations, Theory, Test Methods, Application. 2014 PDA Europe Conference, Brussels, Belgium, 2014, pp 1–230.
3.↵
1. Akers M. J.
1. Guazzo D. M.
Sterile Product-Package Integrity Testing. In Sterile Drug Products; Akers M. J., Ed.; CRC Press: Boca Raton, FL, 2010; pp 455–472.
4.↵
1. Morton D. K.,
2. Lordi N. G.,
3. Ambrosio T. J.
Quantitative and Mechanistic Measurements of Parenteral Vial Container/Closure Integrity. Leakage Quantitation. J. Parenter. Sci. Technol. 1989, 43 (2), 88–97.
OpenUrl PubMed
5.↵
1. Morton D. K.,
2. Lordi N. G.,
3. Troutman L. H.,
4. Ambrosio T. J.
Quantitative and Mechanistic Measurements of Container/Closure Integrity. Bubble, Liquid, and Microbial Leakage Tests. J. Parenter. Sci. Technol. 1989, 43 (3), 104–108.
OpenUrl PubMed
6.↵
1. Kirsch L. E.,
2. Nguyen L.,
3. 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.
OpenUrl Abstract/FREE Full Text
7.↵
1. Kirsch L. E.,
2. Nguyen L.,
3. Moeckly C. S.,
4. Gerth R.
Pharmaceutical Container/Closure Integrity II: The Relationship between Microbial Ingress and Helium Leak Rates in Rubber-Stoppered Glass Vials. PDA J. Pharm. Sci. Technol. 1997, 51 (5), 195–202.
OpenUrl Abstract/FREE Full Text
8.↵
1. Kirsch L. E.
Pharmaceutical Container/Closure Integrity VI: A Report on the Utility of Liquid Tracer Methods for Evaluating the Microbial Barrier Properties of Pharmaceutical Packaging. PDA J. Pharm. Sci. Technol. 2000, 54 (4), 305–314.
OpenUrl Abstract/FREE Full Text
9.↵
1. Burrell L. S.,
2. Carver M. W.,
3. DeMuth G. E.,
4. Lambert W. J.
Development of a Dye Ingress Method To Assess Container-Closure Integrity: Correlation to Microbial Ingress. PDA J. Pharm. Sci. Technol., 2000, 54 (6), 449–455.
OpenUrl Abstract/FREE Full Text
10.↵
1. Keller S.,
2. Marcy J.,
3. Blakistone B.,
4. Hackney C. R.,
5. Carter W. H.,
6. Lacy G. H.
Application of Fluid and Statistical Modeling To Establish the Leak Size Critical to Package Sterility. J. Appl. Pack. Res. 2006, 1 (1), 11–21.
OpenUrl
11.↵
1. Morrical B. D.,
2. Goverde M.,
3. Grausse J.,
4. Gerwig T.,
5. Vorgrimler L.,
6. Morgen R.,
7. Büttiker J.-P.
Leak Testing in Parenteral Packaging: Establishment of Direct Correlation between Helium Leak Rate Measurements and Leak Microbial Ingress for Two Different Leak Types. PDA J. Pharm. Sci. Technol. 2007, 61 (4), 226–236.
OpenUrl Abstract/FREE Full Text
12.↵
1. Nguyen L. T.,
2. Muangsiri W.,
3. Schiere R.,
4. Guazzo D. M.,
5. 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.
OpenUrl Abstract/FREE Full Text
13.↵
1. Wolf H.,
2. Stauffer T.,
3. Chen S.-C.,
4. Lee Y.,
5. Forster R.,
6. Ludzinski M.,
7. Kamat M.,
8. Godorov P.,
9. Guazzo D. M.
Vacuum Decay Container/Closure Integrity Testing Technology. Part 1. ASTM F2338-09 Precision and Bias Studies. PDA J. Pharm. Sci. Technol. 2009, 63 (5), 472–488.
OpenUrl Abstract/FREE Full Text
14.↵
1. Patel J.,
2. Mulhall B.,
3. Wolf H.,
4. Klohr S.,
5. Guazzo D. M.
Vacuum Decay Container Closure Integrity Leak Test Method Development and Validation for a Lyophilized Product-Package System. PDA J. Pharm. Sci. Technol. 2011, 65 (5), 486–505.
OpenUrl Abstract/FREE Full Text
15.↵
1. Yoon S.-Y.,
2. Sagi H.,
3. Goldhammer C.,
4. Li L.
Mass Extraction Container Closure Integrity Physical Testing Method Development for Parenteral Container Closure Systems. PDA J. Pharm. Sci. Technol. 2012, 66 (5), 403–419.
OpenUrl Abstract/FREE Full Text
16.↵
1. Templeton A. C.,
2. Han Y.-H.,
3. Mahajan R.,
4. Chern R. T.,
5. Reed R. A.
Rapid Headspace Oxygen Analysis for Pharmaceutical Packaging Applications. Pharm. Technol. 2002, 26 (7), 44–61.
OpenUrl
17.↵
1. Lin T. P.,
2. Hsu C. C.,
3. Kabakoff B. D.,
4. Patapoff T. W.
Application of Frequency-Modulated Spectroscopy in Vacuum Seal Integrity Testing of Lyophilized Biological Products. PDA J. Pharm. Sci. Technol. 2004, 58 (2), 106–115.
OpenUrl Abstract/FREE Full Text
18.↵
1. Templeton A. C.,
2. Chern R. T.,
3. Reed R. A.,
4. Mahajan R.
Frequency Modulation Spectroscopy. A Novel Nondestructive Approach for Measuring Moisture Activity in Pharmaceutical Samples. Pharm. Technol. 2005, 29 (10), 44–61.
OpenUrl
19.↵
1. Lysfjord J.
1. James Veale J
. New Inspection Techniques for Aseptic Processing. In Practical Aseptic Processing Fill and Finish; Lysfjord J., Ed.; Parenteral Drug Association: Bethesda, MD, 2009; pp 305–327.
20.↵
1. Marrero T. R.,
2. Mason E. A.
Gaseous Diffusion Coefficients. J. Phys. Chem. Ref. Data 1972, 1 (1), 3–118.
OpenUrl
21.↵
1. Welty J. R.,
2. Wicks C. E.,
3. Rorrer G. L.,
4. Wilson R. E.
Fundamentals of Momentum, Heat, and Mass Transfer, 5th ed.; Wiley: New York, 2007.
22.↵
1. Davy J. G.
Model Calculations for Maximum Allowable Leak Rates of Hermetic Packages. J. Vac. Sci. Technol. 1975, 12 (1), 423–429.
OpenUrl
23.↵
1. Morton D. K.
Container/Closure Integrity of Parenteral Vials. PDA J. Pharm. Sci. Technol. 1987, 41 (5), 145–158.
OpenUrl Abstract/FREE Full Text
24.↵
1. Kittel C.,
2. Kroemer H.
Thermal Physics, 2nd ed.; W. H. Freeman and Company: New York, 1980.
25.↵
1. Guazzo D. M.
Personal correspondence, 2017.
26.↵
1. Nieto A.,
2. Roehl H.,
3. Brown H.,
4. Adler M.,
5. Chalus P.,
6. Mahler H.-C.
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. PDA J. Pharm. Sci. Technol. 2016, 70 (4), 313–324.
OpenUrl Abstract/FREE Full Text