Page 149 - Assurance of Sterility for Sensitive Combination Products and Materials

Package/container closures 131

integrity: Correlation to microbial ingress, PDA J. Pharm. Sci. Technol. 54 (6) (2000)
449–455.
[41] Keller, S., Determination of the leak size critical to package sterility maintenance, in
Food Science and Technology. 1998, Faculty of Virginia Polytechnic Institute and State
University: Blacksburg, Virginia. p. 191.
[42] M.J. Akers, Sterile Drug Products: Formulation, Packaging, Manufacturing, and
Quality, Informa Healthcare. ix, New York, 2010, p. 505.
[43] E.T. Hackett, et al., How small is small? The effects of pinholes on medical packaging,
Medical Device and Diagnostic Industry 22 (8) (2000) 52–66.
[44] ASTM International, F1886/F1886M—09 Standard Test Method for Determining
Integrity of Seals for Flexible Packaging by Visual Inspection. 2009: West Consho-
hocken, PA 19428-2959, United States.
[45] ASTM International, ASTM F1929-15 Standard Test Method for Detecting
Seal Leaks in Porous Medical Packaging by Dye Penetration, 2015 (West Consho-
hocken - PA 19428-2959, United States).
[46] ASTM International, F2096-11 Standard Test Method for Detecting Gross Leaks in
Packaging by Internal Pressurization (Bubble Test). 2011: West Conshohocken, PA.
[47] ASTM International, ASTM F2338-09(2013)—Standard Test Method for Nonde-
structive Detection of Leaks in Packages by Vacuum Decay Method. 2013, ASTM
International.
[48] ASTM International, ASTM F3004-13e1—Standard Test Method for Evaluation of
Seal Quality and Integrity Using Airborne Ultrasound. 2013, ASTM International.
[49] L. Jones, et al., Quest of Sterile Packaging: Part I—Approaches to Package Testing,
Medical Device and Diagnostic Industry, 1995.
[50] J. Hansen, et al., Quest of Sterile Packaging: Part II—Physical Package Integrity Test
Methods, Medical Device and Diagnostic Industry, 1995.
[51] A. Tallentire, C.S. Sinclair, Discriminating method for measuring the microbial barri-
er performance of medical packaging papers, Vol. 18, Medical Device and Diagnostic
Industry, 1996, p. 5.
[52] C.S. Sinclair, A. Tallentire, Definition of a correlation between microbiological and
physical particulate barrier performances for porous medical packaging materials,
PDA J. Pharm. Sci. Technol. 56 (1) (2002) 11–19.
[53] ASTM International, ASTM F2638-12e1—Standard Test Method for Using Aerosol
Filtration for Measuring the Performance of Porous Packaging Materials as a Surro-
gate Microbial Barrier, 2016.
[54] P. Herman, C. Larsen, Measuring Porous Microbial Barriers—Part I & II, MDDI, 2008.
[55] Wagner, T., ASTM F2638 Test Method, Porous Packaging Materials & Mi-
crobial Barrier Performance (https://www.packagingdigest.com/testing/
pmp-astm-f2638-test-method-porous-packaging-materials-microbial-barrier-per-
formance-130225). Pharmaceutical & Medical Packaging News, 2013.
[56] H. Dunkelberg, U. Schmelz, Determination of the efficacy of sterile barrier systems
against microbial challenges during transport and storage, Infect. Control Hosp. Epi-
demiol. 30 (2) (2009) 179–183.
[57] H. Dunkelberg, F. Fleitmann-Glende, Measurement of the microbial barrier effective-
ness of sterilization containers in terms of the log reduction value for prevention of
nosocomial infections, Am. J. Infect. Control 34 (5) (2006) 285–289.
[58] H. Dunkelberg, S. Rohmann, Test to determine sterile integrity of wrapped medical
products at a probability of recontamination of 1:1,000,000, Infect. Control Hosp.
Epidemiol. 27 (4) (2006) 367–371.
[59] J. Severin, et al., A new methodology for whole-package microbial challenge testing
for medical device trays, J. Test. Eval. 35 (4) (2007) 373–380.
[60] ASTM International, F88/F88M-09 Standard Test Method for Seal Strength of Flex-