CCIT Positive Control Samples

CCIT Positive control sample refers to packaging containers with known leakage pores created by laser punching, micro- pipette/capillary piercing, etc.
The positive sample is used for leak test method development and validation. Positive controls were used during the development and validation of the leak test method. Some also require the use of positive samples in routine testing.
Laser Drill - an authoritative positive sample preparation technology recommended by FDA and cited by USP1207.
A laser beam of a certain wavelength is applied to a point on the surface of the packaging system.
The laser beam is absorbed and heat is generated at the spot, and the material is melted and vaporized. The rate of drilling can be controlled by laser beam parameters, but the depth of the hole cannot be controlled. Therefore, for packaging materials with uneven wall thickness, the desired hole size can only be created by trial-and-error methods. The geometry of the laser drilling is a conical hole that partially protruded into the side wall and resulted in tiny cracks that formed a twisted irregular channel.

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