Container Closure Integrity Testing
LexaMed offers testing of sealed, flexible, breathable packages via aerosolized spore challenge. We also have the capability to challenge the Container Closure Integrity (CCI) of non-porous packages, including vials, ampoules and bottles, by either dye or microbial ingress, with the option of employing dynamic pressure differentials. Our custom stainless steel, Teflon® coated pressure/vacuum vessel has a 5 gallon (~19 Liter) capacity and has been validated to maintain pressures ranging from 22 inHg vacuum to 50 psig and also offers a controlled rate of pressure differential testing that is consistent with commonly referenced standards such as ASTM D6653 and D4991. Positive control closure breach size can be varied utilizing needles, glass capillary tubing, or laser drilled holes. Microbial ingress testing utilizes Brevundimoas diminuta grown under conditions to result in small cell size.
Testing is covered under PDA Technical Report 27.