RT Journal Article
SR Electronic
T1 Vacuum Decay Container/Closure Integrity Testing Technology. Part 1. ASTM F2338-09 Precision and Bias Studies
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 472
OP 488
VO 63
IS 5
A1 Heinz Wolf
A1 Tony Stauffer
A1 Shu-Chen Y. Chen
A1 Yoojin Lee
A1 Ronald Forster
A1 Miron Ludzinski
A1 Madhav Kamat
A1 Phillip Godorov
A1 Dana Morton Guazzo
YR 2009
UL http://journal.pda.org/content/63/5/472.abstract
AB ASTM F2338-09 Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method is applicable for leak-testing rigid and semi-rigid non-lidded trays; trays or cups sealed with porous barrier lidding materials; rigid, nonporous packages; and flexible, nonporous packages. Part 1 of this series describes the precision and bias studies performed in 2008 to expand this method's scope to include rigid, nonporous packages completely or partially filled with liquid. Round robin tests using three VeriPac 325/LV vacuum decay leak testers (Packaging Technologies & Inspection, LLC, Tuckahoe, NY) were performed at three test sites. Test packages were 1-mL glass syringes. Positive controls had laser-drilled holes in the barrel ranging from about 5 to 15 μm in nominal diameter. Two different leak tests methods were performed at each site: a “gas leak test” performed at 250 mbar (absolute) and a “liquid leak test” performed at about 1 mbar (absolute). The gas leak test was used to test empty, air-filled syringes. All defects with holes ≥5.0 μm and all no-defect controls were correctly identified. The only false negative result was attributed to a single syringe with a <5.0-μm hole. Tests performed using a calibrated air leak supported a 0.10-cm3 · min−1 (ccm) sensitivity limit (99/99 lower tolerance limit). The liquid leak test was used to test both empty, air-filled syringes and water-filled syringes. Test results were 100% accurate for all empty and water-filled syringes, both without holes and with holes (5, 10, and 15 μm). Tests performed using calibrated air flow leaks of 0, 0.05, and 0.10 ccm were also 100% accurate; data supported a 0.10-ccm sensitivity limit (99/99 lower tolerance limit). Quantitative differential pressure results strongly correlated to hole size using either liquid or gas vacuum decay leak tests. The higher vacuum liquid leak test gave noticeably higher pressure readings when water was present in the defect. Both the ASTM F2338-09 test method and the precision and bias study report are available by contacting ASTM International in West Conshohocken, PA, USA (www.astm.org). © PDA, Inc. 2009