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25691719,26889055,20158053,30651337,28733333,20158052,22293838,27020649,23035025,27789803,11107837,31101708,24265304,29626532,26797976,30361284,10177326,29853608,26659102,24265305,24265306,29030527,10754714,26797971,31004038,25336420,33067331,10754718,9846069,29954924,29444991,23035029,24265307,29545324,26889053,25691717,14677630,29030531,20088243,10969527,20527517,11057094,26797973,9357306,29730259,33858948,30651335,33709236,26797967,23839955,31545968,9357305,22634593,31732689,17933206,32789444,29343617,28538204,31751941,22293836,22293233,26865679,31051250,29853611,30361287,21319164,24643749,28928290,28089964,20632866,26048747,9691673,32060224,26006333,20088249,25769293,28089965,29954923,29158288,32540864,28632533,24955780,24643773,9357304,21057904,31420507,32817321,26654992,32862255,26714367,20227495,9038084,33504510,21538214,3953587,17308256,22293525,27974627,31308066,15113076,33452050,2278263,30075935,9610171,9038086,29432763,26659100,21324833,9846073,24668600,25681722,26397317,23035027,24668602,20039383,30153890,29373043,32023211,24084658,17969619,30263623,28279928,19822828,2732847,32675308,29746405,11367931,26337855,18541688,33540011,17585428,22293523,24938618,3918439,30828350,28416646,2709241,21501999,30296419,31420506,32743712,31420501,29242394,29284358,26490809,19483420,27325595,29331438,13130288,32274594,17823109,33585996,31277955,33217252,28928291,21502024,20484215,22293834,9428880,5675506,22492599,30770485,30030347,17468145,26659104,31473212,29602568,21502063,27100074,7671041,23071944,17077539,30422015,31004039,22307658,26889052,33199514,25364017,27789800,14521036,30232141,23129865,11740219,33983076,22767879,29274583,30339866,30471289,30391415,9615155,19890087,22767885,29478716,24494727,27100073,31732690,12586575,32414526,24084663,24610680,14531639,21414943,30379831,31615925,33307042,30232139,31156055,21057795,30586662,29981566,12779289,32679217,26659101,30361282,28804109,13130286,23872446,7677111,22293837,31628922,22293234,21502072,22492597,28804892,28465152,24084659,16512255,7412683,15292893,14503733,2192024,23506207,9585283,27974591,32871152,25228786,33359313,11089283,9766069,12870762,31302170,30232140,23872447,29972107,20076777,32745562,28935251,34024924,26659106,29579817,21501998,30013330,21502076,20204091,33990422,32107671,28948584,31519783,14622937,17877437,26659103,29030529,28790869,16595805,24265301,31475853,32415524,26412668,10469100,32990191,9101020,30788181,8587050,957113,3530058,31359743,2279005,9876591,32700608,13130287,6715560,34297692,21414939,31705211,3952790,31941793,2190636,30763471,34197975,7553439,14571396,34131016,9410433,23894868,17523004,2272940,2278394,28241221,29330637,12561669,33189808,29421215,8933421,19783459,12374072,3084173,1782904,29976851,32467178,1472748,34055435,30939700,32746351,15259760,3954348,26684535,19149527,11109250,7603744,30482802,32017902,32244706,28776899,1056972,11765040,28738580,29432266,34111968,29768959,31159077,32287169,13130285,32584864,26111307,3968369,16205578,32037027,30656503,1802979,347049,30098394,21566715,10740565,11931796,28404759,33990420,21096782,16761792,3334452,23035028,22888448,28804879,31717317,3772755,16875143,23833515,34131014,31003295,30205433,4045628,25361839,12448571,34297694,30027813,23231611,9842856,18653815,34153994,12779281,2272941,3275302,13919993,4115583,2710568,24102542,1089707,9237127,34288752,6349190,30196040,7436844,13114693,16030371,33354522,20268498,1994942,14262885,20957099,27078575,31988892,31552933,31195582,15418044,1747396,31159076,29497461,32559719,18139614,9179981,14183219,11258870,32478751,21014018,26106278,14328120,31315081,18148898,27906611,2339896,30856722,15945288,845797,14785536,7091618,14466140,32755240,29933589,33082147,20289476,15571203,10666798,25231152,21946318,629124,33656180,30696110,6660377,16570865,18146769,16178810,26242788,32467175,11463045,12790819,23385564,16570864,20342852,31051602,13757222,31948372,20270002,5072408,14616646,23226978,2511215,1493538,32621696,30856714,14899242,14773938,28788464,33655880,34089713,933294,31370467,31623301,31544599,1211592,16811010,33608468,2019507,21253,14890728,32315663,25294983,32425131,33493478,31532950,15348159,31625337,31062221,32023221,32365714,26272542,11315024,14587593,11235445,32154680,18130301,32158864,32290161,15434372,27493544,8734679,32655211,26417170,13051811,33536182,18101907,32438904,13030671,30399854,33362407,31167413,31336795,4725542,861772,28685999,33808625,32035940,8289127,31382614,20255128,31386458,25674480,8250179,30938795,34203022,8207702,27512177,34243264,29491691,33875826,28773149,20270625,32189760,10013318,31406936,32486706,33824687,30822940,10017186,10016394,10014686,10014112,10020196,10013759,9956380,9962858,21547200,32425113,9901928,18010315,10016868,10013397,10012231,9958273,9953046,9912508,9903232,9968724,16811112,9971385,9954435,26957878,27546943,5543469,30750058,33911656,30494569,16652758,24043174,23431280,10016268,33888237,33888236,28665080[uid]

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Page 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. Simonetti A, et al. PDA J Pharm Sci Technol. 2015 Jan-Feb;69(1):108-22. doi: 10.5731/pdajpst.2015.01004. PDA J Pharm Sci Technol. 2015. PMID: 25691719

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. Lu X, et al. PDA J Pharm Sci Technol. 2016 Jan-Feb;70(1):39-50. doi: 10.5731/pdajpst.2015.006015. PDA J Pharm Sci Technol. 2016. PMID: 26889055

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. Wolf H, et al. PDA J Pharm Sci Technol. 2009 Sep-Oct;63(5):489-98. PDA J Pharm Sci Technol. 2009. PMID: 20158053

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. Peláez SS, et al. PDA J Pharm Sci Technol. 2019 May-Jun;73(3):220-234. doi: 10.5731/pdajpst.2018.009332. Epub 2019 Jan 16. PDA J Pharm Sci Technol. 2019. PMID: 30651337

Method Development for Container Closure Integrity Evaluation via Headspace Gas Ingress by Using Frequency Modulation Spectroscopy.

Victor KG, Levac L, Timmins M, Veale J. Victor KG, et al. PDA J Pharm Sci Technol. 2017 Nov-Dec;71(6):429-453. doi: 10.5731/pdajpst.2017.007518. Epub 2017 Jul 20. PDA J Pharm Sci Technol. 2017. PMID: 28733333

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. Wolf H, et al. PDA J Pharm Sci Technol. 2009 Sep-Oct;63(5):472-88. PDA J Pharm Sci Technol. 2009. PMID: 20158052

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. Patel J, et al. PDA J Pharm Sci Technol. 2011 Sep-Oct;65(5):486-505. doi: 10.5731/pdajpst.2011.00780. PDA J Pharm Sci Technol. 2011. PMID: 22293838

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. Nieto A, et al. PDA J Pharm Sci Technol. 2016 Jul-Aug;70(4):313-24. doi: 10.5731/pdajpst.2015.006080. Epub 2016 Mar 28. PDA J Pharm Sci Technol. 2016. PMID: 27020649

Mass extraction container closure integrity physical testing method development for parenteral container closure systems.

Yoon SY, Sagi H, Goldhammer C, Li L. Yoon SY, et al. PDA J Pharm Sci Technol. 2012 Sep-Oct;66(5):403-19. doi: 10.5731/pdajpst.2012.00878. PDA J Pharm Sci Technol. 2012. PMID: 23035025

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. Brown H, et al. PDA J Pharm Sci Technol. 2017 Mar-Apr;71(2):147-162. doi: 10.5731/pdajpst.2016.006999. Epub 2016 Oct 27. PDA J Pharm Sci Technol. 2017. PMID: 27789803