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 or leak artifacts for test method development and validation.
Most companies as of late, are focused on implementing cGMP-current Good Manufacturing Practice-in all of their validation processes. While there is much focus on leak test equipment, whether it be legacy equipment for vacuum decay and dye ingress leak testing, or newer leak test equipment such as laser headspace analysis systems or high voltage leak detection systems, it is important not to forget the requirement for good positive controls with calibrated leaks. Positive controls ensure that your leak testers are working properly, and that the testers are able to find even the most challenging leak artifacts.
Positive controls or calibrated leaks are created by drilling a known, measured micro hole in a package. These are used in the production process by defining the maximum allowable leak limit (MALL) and 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 5µm to 100µm (and larger) in glass vials, glass ampoules, plastic vials, blister packs, IV bags, intravenous pouches, and other drug containers/container closure systems. Our laser systems are also able to drill in different locations in a package, e.g. the neck, body, or bottom of a vial. In addition, Oxford Lasers provides precision pin holes or calibrated leaks in various metals. Precision drilled in 3mm discs that can be easily affixed to container closure systems such as blister packs , vials, and plastic packs covering a larger less precise hole that exists in the pack or container.
Employing the industry demands in good manufacturing practices (cGMP) Oxford Lasers currently supplies micron scale holes for CCIT and leak testing to pharmaceutical end users, leak test equipment OEMs, as well as pharmaceutical and medical process consultants throughout the world. We are a leader in providing Positive Controls used for test method development and validation. Call on us today to help you with your CCIT needs.
If you would like more information or to request a quote, please contact us today.
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