Leak Test Hole Drilling (CCIT)
Potomac is a leader in laser drilling of calibrated holes for leak testing applications.
Potomac is able to laser drill micro-holes into glass and polymer vials/ampules for the purpose of leak test hole system validation. A range of hole sizes can be created in order to replicate defects in vials for use when calibrating leak detection devices. Depending upon the wall thickness of the vial/ampule, hole sizes can be as small as 1µm. In addition to vials, foil and blister packs can also be laser drilled. Potomac Photonics is ISO 13485 certified and we have drilled hundred of thousands of packages for the pharmaceutical, food and medical industries.
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
Industries / Application include:
- Pharmaceutical
- Medical Device
- Biotechnology
- Food / Packaging
Packaging:
- Vials
- Ampoules
- Pouches (filled or unfilled)
- Bags
- Filled and Sealed Bottles
- Metal contaners
- Foil and blister packs
Potomac Photonics has successfully completed thousands of leak testing projects (CCIT) for leading pharmaceutical companies, involving glass vials, plastic containers, gloves, and various other items critical to drug packaging and delivery. With their state-of-the-art laser technology, Potomac is capable of drilling holes as small as 1 micron, ensuring unmatched precision in their work. As an ISO 13485 certified company, Potomac Photonics upholds the highest quality standards and provides a Certificate of Conformance for each project, assuring clients of their commitment to excellence. The importance of leak testing (CCIT) in the pharmaceutical industry cannot be overstated, as it is directly linked to drug safety and contamination prevention. By partnering with Potomac Photonics, pharmaceutical companies can rely on cutting-edge technology and expertise to maintain the integrity of their container closure systems, ultimately protecting public health and ensuring regulatory compliance.
