Wolf Heinz, Stauffer Tony, Chen Shu-Chen Y, Lee Yoojin, Forster Ronald, Ludzinski Miron, Kamat Madhav, Mulhall Brian, Guazzo Dana Morton
Packaging Technologies & Inspection, LLC, Tuckahoe, NY 10707, USA.
PDA J Pharm Sci Technol. 2009 Sep-Oct;63(5):489-98.
Part 1 of this series demonstrated that a container closure integrity test performed according to ASTM F2338-09 Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method using a VeriPac 325/LV vacuum decay leak tester by Packaging Technologies & Inspection, LLC (PTI) is capable of detecting leaks > or = 5.0 microm (nominal diameter) in rigid, nonporous package systems, such as prefilled glass syringes. The current study compared USP, Ph.Eur. and ISO dye ingress integrity test methods to PTI's vacuum decay technology for the detection of these same 5-, 10-, and 15-microm laser-drilled hole defects in 1-mL glass prefilled syringes. The study was performed at three test sites using several inspectors and a variety of inspection conditions. No standard dye ingress method was found to reliably identify all holed syringes. Modifications to these standard dye tests' challenge conditions increased the potential for dye ingress, and adjustments to the visual inspection environment improved dye ingress detection. However, the risk of false positive test results with dye ingress tests remained. In contrast, the nondestructive vacuum decay leak test method reliably identified syringes with holes > or = 5.0 microm.
本系列的第1部分表明，使用包装技术与检验有限责任公司（PTI）的VeriPac 325/LV真空衰减泄漏测试仪，按照ASTM F2338 - 09《真空衰减法无损检测包装泄漏的标准试验方法》进行的容器密封完整性测试，能够检测刚性、无孔包装系统（如预填充玻璃注射器）中直径大于或等于5.0微米（标称直径）的泄漏。当前研究将美国药典（USP）、欧洲药典（Ph.Eur.）和国际标准化组织（ISO）的染料渗入完整性测试方法与PTI的真空衰减技术进行比较，以检测1毫升玻璃预填充注射器中同样的5微米、10微米和15微米激光钻孔缺陷。该研究在三个测试地点进行，使用了多名检验员并设置了多种检验条件。未发现有标准染料渗入方法能可靠地识别所有带孔注射器。对这些标准染料测试的挑战条件进行修改增加了染料渗入的可能性，对目视检查环境进行调整改善了染料渗入检测。然而，染料渗入测试仍存在假阳性测试结果的风险。相比之下，无损真空衰减泄漏测试方法能可靠地识别出有大于或等于5.0微米孔洞的注射器。
