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Items: 1 to 20 of 96

1.

Use of leftovers of monoclonal antibody products after partial extraction - A microbiological safety study.

Arnamo AH, Huitema AD, Beijnen JH, Nuijen B.

J Oncol Pharm Pract. 2019 Jun 2:1078155219850297. doi: 10.1177/1078155219850297. [Epub ahead of print]

PMID:
31156055
2.

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 Nov-Dec;72(6):544-552. doi: 10.5731/pdajpst.2017.008383. Epub 2018 May 31.

PMID:
29853608
3.

Container/Closure Integrity Testing and the Identification of a Suitable Vial/Stopper Combination for Low-Temperature Storage at -80 {degrees}C.

Zuleger B, Werner U, Kort A, Glowienka R, Wehnes E, Duncan D.

PDA J Pharm Sci Technol. 2012 Sep-Oct;66(5):453-65. doi: 10.5731/pdajpst.2012.00884.

PMID:
23035029
4.

Evaluation of Container Closure System Integrity for Frozen Storage Drug Products.

Nieto A, Roehl H, Brown H, Nikoloff J, Adler M, Mahler HC.

PDA J Pharm Sci Technol. 2016 Mar-Apr;70(2):120-33. doi: 10.5731/pdajpst.2015.006098. Epub 2016 Jan 21.

PMID:
26797976
5.

Quantifying the Vial Capping Process: Residual Seal Force and Container Closure Integrity.

Ovadia R, Streubel A, Webb-Vargas Y, Ulland L, Luemkemann J, Rauch K, Eder J, Lam P, Tegoulia V, Maa YF.

PDA J Pharm Sci Technol. 2019 Jan-Feb;73(1):2-15. doi: 10.5731/pdajpst.2018.008797. Epub 2018 Jun 27.

PMID:
29954924
6.

Characterization of surface properties of glass vials used as primary packaging material for parenterals.

Ditter D, Mahler HC, Roehl H, Wahl M, Huwyler J, Nieto A, Allmendinger A.

Eur J Pharm Biopharm. 2018 Apr;125:58-67. doi: 10.1016/j.ejpb.2017.12.018. Epub 2018 Jan 10.

PMID:
29331438
7.

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 Jul-Aug;70(4):313-24. doi: 10.5731/pdajpst.2015.006080. Epub 2016 Mar 28.

PMID:
27020649
8.

Novel Mechanism of Glass Delamination in Type 1A Borosilicate Vials Containing Frozen Protein Formulations.

Jiang G, Goss M, Li G, Jing W, Shen H, Fujimori K, Le L, Wong L, Wen ZQ, Nashed-Samuel Y, Riker K, Germansderfer A, Tsang P, Ricci M.

PDA J Pharm Sci Technol. 2013 Jul-Aug;67(4):323-35. doi: 10.5731/pdajpst.2013.00925.

PMID:
23872443
9.

The Pharmaceutical Capping Process-Correlation between Residual Seal Force, Torque Moment, and Flip-off Removal Force.

Mathaes R, Mahler HC, Vorgrimler L, Steinberg H, Dreher S, Roggo Y, Nieto A, Brown H, Roehl H, Adler M, Luemkemann J, Huwyler J, Lam P, Stauch O, Mohl S, Streubel A.

PDA J Pharm Sci Technol. 2016 May-Jun;70(3):218-29. doi: 10.5731/pdajpst.2015.006106. Epub 2016 Jan 21.

PMID:
26797973
10.

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 Mar-Apr;73(2):170-180. doi: 10.5731/pdajpst.2018.008680. Epub 2018 Oct 25.

PMID:
30361284
11.

"Product on Stopper" in a Lyophilized Drug Product: Cosmetic Defect or a Product Quality Concern?

Mehta SB, Roy S, Yang HC.

J Pharm Sci. 2018 Jun;107(6):1736-1740. doi: 10.1016/j.xphs.2018.02.001. Epub 2018 Feb 9.

PMID:
29432763
12.

Impact of Vial Capping on Residual Seal Force and Container Closure Integrity.

Mathaes R, Mahler HC, Roggo Y, Ovadia R, Lam P, Stauch O, Vogt M, Roehl H, Huwyler J, Mohl S, Streubel A.

PDA J Pharm Sci Technol. 2016 Jan-Feb;70(1):12-29. doi: 10.5731/pdajpst.2015.005876.

PMID:
26889053
13.

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 Nov-Dec;71(6):429-453. doi: 10.5731/pdajpst.2017.007518. Epub 2017 Jul 20.

PMID:
28733333
14.

Residual Seal Force Testing: A Suitable Method for Seal Quality Determination of (High Potent) Parenterals.

Buecheler JW, Luemkemann J, Gieseler H, Mohl S, Streubel A.

PDA J Pharm Sci Technol. 2019 Mar-Apr;73(2):111-120. doi: 10.5731/pdajpst.2018.008870. Epub 2018 Oct 25.

PMID:
30361287
15.

Predictions of vacuum loss of evacuated vials from initial air leak rates.

Prisco MR, Ochoa JA, Yardimci AM.

J Pharm Sci. 2013 Aug;102(8):2730-7. doi: 10.1002/jps.23652. Epub 2013 Jul 9.

PMID:
23839955
16.

Microbiological performance of a robotic system for aseptic compounding of cytostatic drugs.

Geersing TH, Franssen EJF, Pilesi F, Crul M.

Eur J Pharm Sci. 2019 Mar 15;130:181-185. doi: 10.1016/j.ejps.2019.01.034. Epub 2019 Jan 31.

PMID:
30710619
17.

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 Sep-Oct;66(5):403-19. doi: 10.5731/pdajpst.2012.00878.

PMID:
23035025
18.

Lack of latex allergen contamination of solutions withdrawn from vials with natural rubber stoppers.

Thomsen DJ, Burke TG.

Am J Health Syst Pharm. 2000 Jan 1;57(1):44-7.

PMID:
10630556
19.

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 Sep-Oct;65(5):486-505. doi: 10.5731/pdajpst.2011.00780.

PMID:
22293838
20.

A method to quantitatively define and assess the risk of cosmetic glass defects on tubing glass vials.

Loui AW.

PDA J Pharm Sci Technol. 2011 Jul-Aug;65(4):380-91. doi: 10.5731/pdajpst.2011.00677.

PMID:
22293525

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