Calibrated micro holes for Container Closure Integrity Testing (CCIT) aid in the validation of packaging processes.
Leak testing is a critical part of any drug packaging line. Pharmaceutical standards such as USP 1207 and EU Annex 1 require deterministic leak testing of packages, as well as confirmation that leak testing equipment is functioning properly. These processes, often known as CCIT (Container Closure Integrity Testing) or CCI testing, require positive controls.
Positive controls are created by drilling a known, measured micro hole in a package. These are used in the production process thereby providing deterministic proof that the leak tester is operating properly.
Oxford Lasers houses numerous laser micromachining systems which have been designed and built to machine a wide range of materials, including challenging materials such as glass and plastics. We are therefore able to drill micro holes from 5um to 100um (and larger) in glass vials, glass ampoules, plastic vials, blister packs, bags, and other drug containers. Our systems are also able to drill in different locations in a package, e.g. the neck, body, or bottom of a vial.
We also provide precision pin holes in steel. These 3mm discs are stuck to product such as blister packs and plastic packs above a larger less precise hole.
Oxford Lasers currently supplies micro holes for CCIT and leak testing to pharmaceutical end users, leak tester OEM’s, and pharmaceutical and medical process consultants throughout the world. Call on us to help you with your CCIT needs.
If you would like more information or to request a quote, please contact us today.