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Area of Technology:Engineering Sciences

Title of the Innovation: Process Technology for Leak Test Hole Drilling for Container Closure Integrity Testing (CCIT)

Brief About Innovation

Process Technology for Leak Test Hole Drilling for Container Closure Integrity Testing (CCIT)

Laser drilling of micro-holes into glass and polymer vials/ ampoules 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.

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)

Specification:
Depending upon the wall thickness of the vial/ampoule, hole sizes can be as small as 1 µm
Level of Development:
Ready for Technology Transfer
Major Plant Equipment and Machines required:
High Precision Ultra Fast Pulsed Laser Micro Machining System
Packaging Elements for CCIT:
Vials, Ampoules, Pouches (filled or unfilled), Bags, Filled and Sealed Bottles, Metal containers, Foil and blister packs

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.

Techno economics :
Indigenous development of technology and having high potential in the commercialization of the process
Technology Package:
Process Technology for Laser machining
Industries / Application include: