Andrea Simonetti, Director Business Development, QA & Validation Manager – Bonfiglioli Engineering S.p.A., a TASI GROUP Company
Container Closure Integrity Testing (CCIT) for pharmaceuticals, has significant relevance in terms of quality, safety and correct functionality of drug products. Also, it is linked both to financial aspects and to the image of the manufacturing company.
In this context, the use of dye solutions, such as methylene blue, in combination with extended application of negative pressure levels (vacuum), is an industrial standard named Dye Ingress Test, that is widely used, throughout the pharmaceutical field, to determine containers integrity defects and to reject containers that do not conform to specifications. Dye Ingress Test, due to its destructive nature, does not allow complete examination of the entire production; for this reason, it is generally performed on samples, at regular intervals, during the production cycle. In reason of this, when containers, that do not conform to integrity specifications, are detected, the entire batch (or at least a substantial portion of it) is rejected. Therefore, none of the containers produced, between two successive sampling stages, are placed on the market, since real testing has not been performed and it is assumed that the integrity status is equal to that of the small sample examined. Furthermore, this approach is unquestionably linked to the subjectivity of operators, who visually inspect the reference containers, to check whether there is any dye solution inside them. Finally, further limitations, linked to the use of this approach, include the randomness of the process, the total cost and the low sensitivity of the measurement.
