785 related articles for article (PubMed ID: 25691719)
1. Non-destructive vacuum decay method for pre-filled syringe closure integrity testing compared with dye ingress testing and high-voltage leak detection.
Simonetti A; Amari F
PDA J Pharm Sci Technol; 2015; 69(1):108-22. PubMed ID: 25691719
[TBL] [Abstract][Full Text] [Related]
2. Feasibility of Using Fluorescence Spectrophotometry to Develop a Sensitive Dye Immersion Method for Container Closure Integrity Testing of Prefilled Syringes.
Lu X; Lloyd DK; Klohr SE
PDA J Pharm Sci Technol; 2016; 70(1):39-50. PubMed ID: 26889055
[TBL] [Abstract][Full Text] [Related]
3. Vacuum decay container/closure integrity testing technology. Part 2. Comparison to dye ingress tests.
Wolf H; Stauffer T; Chen SC; Lee Y; Forster R; Ludzinski M; Kamat M; Mulhall B; Guazzo DM
PDA J Pharm Sci Technol; 2009; 63(5):489-98. PubMed ID: 20158053
[TBL] [Abstract][Full Text] [Related]
4. Comparing Physical Container Closure Integrity Test Methods and Artificial Leak Methodologies.
Peláez SS; Mahler HC; Herdlitschka C; Wertli T; Kahl M; Koulov A; Matter A; Singh SK; Widmer M; Germershaus O; Mathaes R
PDA J Pharm Sci Technol; 2019; 73(3):220-234. PubMed ID: 30651337
[TBL] [Abstract][Full Text] [Related]
5. Method Development for Container Closure Integrity Evaluation via Headspace Gas Ingress by Using Frequency Modulation Spectroscopy.
Victor KG; Levac L; Timmins M; Veale J
PDA J Pharm Sci Technol; 2017; 71(6):429-453. PubMed ID: 28733333
[TBL] [Abstract][Full Text] [Related]
6. Vacuum decay container/closure integrity testing technology. Part 1. ASTM F2338-09 precision and bias studies.
Wolf H; Stauffer T; Chen SC; Lee Y; Forster R; Ludzinski M; Kamat M; Godorov P; Guazzo DM
PDA J Pharm Sci Technol; 2009; 63(5):472-88. PubMed ID: 20158052
[TBL] [Abstract][Full Text] [Related]
7. Vacuum decay container closure integrity leak test method development and validation for a lyophilized product-package system.
Patel J; Mulhall B; Wolf H; Klohr S; Guazzo DM
PDA J Pharm Sci Technol; 2011; 65(5):486-505. PubMed ID: 22293838
[TBL] [Abstract][Full Text] [Related]
8. Container Closure Integrity Testing-Practical Aspects and Approaches in the Pharmaceutical Industry.
Brown H; Mahler HC; Mellman J; Nieto A; Wagner D; Schaar M; Mathaes R; Kossinna J; Schmitting F; Dreher S; Roehl H; Hemminger M; Wuchner K
PDA J Pharm Sci Technol; 2017; 71(2):147-162. PubMed ID: 27789803
[TBL] [Abstract][Full Text] [Related]
9. 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.
Nieto A; Roehl H; Brown H; Adler M; Chalus P; Mahler HC
PDA J Pharm Sci Technol; 2016; 70(4):313-24. PubMed ID: 27020649
[TBL] [Abstract][Full Text] [Related]
10. Development of a dye ingress method to assess container-closure integrity: correlation to microbial ingress.
Burrell LS; Carver MW; DeMuth GE; Lambert WJ
PDA J Pharm Sci Technol; 2000; 54(6):449-55. PubMed ID: 11107837
[TBL] [Abstract][Full Text] [Related]
11. Balancing Container Closure Integrity and Aesthetics for a Robust Aseptic or Sterile Vial Packaging System.
Oni Y; Song X; Schrader M; Kulshrestha A; Franck J; Asselta R; Flores-Crespo C; Mantri RV
PDA J Pharm Sci Technol; 2019; 73(6):572-587. PubMed ID: 31101708
[TBL] [Abstract][Full Text] [Related]
12. Mass extraction container closure integrity physical testing method development for parenteral container closure systems.
Yoon SY; Sagi H; Goldhammer C; Li L
PDA J Pharm Sci Technol; 2012; 66(5):403-19. PubMed ID: 23035025
[TBL] [Abstract][Full Text] [Related]
13. Container Closure Integrity Testing of Prefilled Syringes.
Peláez SS; Mahler HC; Matter A; Koulov A; Singh SK; Germershaus O; Mathaes R
J Pharm Sci; 2018 Aug; 107(8):2091-2097. PubMed ID: 29626532
[TBL] [Abstract][Full Text] [Related]
14. Container Closure Integrity Testing-Method Development for Freeze-Dried Products Using Laser-Based Headspace Oxygen Analysis.
Hede JO; Fosbøl PL; Berg SW; Dahl S
PDA J Pharm Sci Technol; 2019; 73(2):170-180. PubMed ID: 30361284
[TBL] [Abstract][Full Text] [Related]
15. High-voltage leak detection of a parenteral proteinaceous solution product packaged in form-fill-seal plastic laminate bags. Part 1. Method development and validation.
Damgaard R; Rasmussen M; Buus P; Mulhall B; Guazzo DM
PDA J Pharm Sci Technol; 2013; 67(6):634-51. PubMed ID: 24265304
[TBL] [Abstract][Full Text] [Related]
16. Risk Mitigation of Plunger-Stopper Displacement Under Low Atmospheric Pressure by Establishing Design Space for Filling-Stoppering Process of Prefilled Syringes: A Design of Experiment (DoE) Approach.
Mehta SB; Cook J; Liu W; Brisbane C
J Pharm Sci; 2022 Jul; 111(7):2038-2048. PubMed ID: 35122830
[TBL] [Abstract][Full Text] [Related]
17. Integrity performance assessment of a closed system transfer device syringe adaptor lock as a terminal closure for Luer-Lock syringes.
Wilkinson AS; Walker KE; Ozolina L; Machníková R; Johnson AJ; Bhogal N; Pegg K
Eur J Hosp Pharm; 2023 Dec; 31(1):50-56. PubMed ID: 35410874
[TBL] [Abstract][Full Text] [Related]
18. Draft guidance for industry; container and closure integrity testing in lieu of sterility testing as a component of the stability protocol for sterile products; availability--FDA. Notice.
Fed Regist; 1998 Jan; 63(18):4272-3. PubMed ID: 10177326
[TBL] [Abstract][Full Text] [Related]
19. Evaluation of Container Closure System Integrity for Storage of Frozen Drug Products: Impact of Capping Force and Transportation.
Nieto A; Roehl H; Adler M; Mohl S
PDA J Pharm Sci Technol; 2018; 72(6):544-552. PubMed ID: 29853608
[TBL] [Abstract][Full Text] [Related]
20. Container Closure Integrity Test Using Frequency Modulation Spectroscopy Headspace Analysis with Carbon Dioxide as a Tracer Gas.
Caudill AA; Victor K; Timmins M; Veale J
PDA J Pharm Sci Technol; 2021; 75(2):157-172. PubMed ID: 33067331
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]