Leak Test Hole Drilling (CCIT)

Leak testing or Container Closure Integrity Testing (CCIT) is an assay that evaluates the adequacy of container closure systems to maintain a sterile barrier against potential contaminants. Contaminants that could potentially cross a container closure barrier include microorganisms, reactive gases, and other substances (USP <1207>). Container closure systems should maintain the sterility and product quality of sterile final pharmaceutical, biological, and vaccine products throughout their shelf-life (Ewan, S. et al., 2015).

Container closure systems consist of primary packaging components and secondary packaging components (USP <1207>). Primary packaging components are those components that come into direct contact with the product, such as a glass vial or syringe. While, secondary packaging components are those components that are vital to ensure correct package assembly, such as aluminum caps over stoppers (USP <1207>). (Source: America Pharmaceutical Review)

Advantages of laser drilled leak test holes include:

• Better resemble natural defects in glass (cracks) and polymers (pinholes).
• Tight tolerances can be achieved in most material and thicknesses.
• Hole diameter sets and calibration packages can be customized based on customer requirements. 

A Certificate of Conformance and Quality Data Sheet is included with each Leak Test Hole Drilling Order.

• Leak test holes as small as 1 micron
• Accurate leak hole placement
• Expedited delivery if required.
• Our measurement equipment is calibrated utilizing a NIST traceable standard.
• We have partnered with industry leaders to provide them with leak test holes that are compatible with all detection technologies.

Our customers partner with us to drill leak test holes for testing methods such as:

• Electrical Conductivity and Capacitance Test (HVLD)
• Laser-based Gas Headspace Analysis
• Mass Extraction
• Pressure Decay
• Tracer Gas (vacuum mode)
• Vacuum Decay