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Find past articles at Click on Article Archive. Need info? New subscriber? www.tabletscapsules.com are not validated to detect leaks smaller than 50 microns and, as noted above, an even smaller leak can have a big impact on the package contents. How big an impact and how fast it occurs depend on how sensitive the active ingredient(s) is/are to ambient conditions. Once you determine that, scrutinize your test method's reliability and validate it according to leak size. If you find that ambient moisture and oxygen conditions don't affect the tablet or capsule, maybe the blue dye method is appropriate, at least for that application. Seek better methods Fortunately, superior technologies are available, including nondestruc- tive methods such as volumetric imaging under vacuum [2]. With this method, you enter the number of blister cavities, place the blister pack- age on the inspection plate, and press "Start." In less than 15 seconds, the equipment passes or fails the package and identifies the defective cavity (photo). It finds defects as small as 10 microns and requires no tools or changes to test parameters. With any inspection method or protocol, the reliability of the test results is key. If the results aren't reli- able, it's not really a test method. As drug products become more sensitive to environmental conditions, it's important to be vigilant and to re- evaluate your test methodology for its ability to provide reliable detec- tion of critical defects. T&C References 1. The revised standards took effect in August 2016. See the first supplement to USP 39-NF 34, US Pharmacopeia, Rockville, MD. 2. VeriPac UBV from PTI, Tuckahoe, NY. Oliver Stauffer is chief executive officer or Packaging Technologies and Inspec- tion, 145 Main Street, Tuckahoe, NY 10707. Tel. 914 337 2005. Website: www.ptiusa.com. 34 October 2016 Tablets & Capsules