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), require positive controls or certified leak defects for test method development and validation.

Most companies 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 or high voltage leak detection (HVLD) 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 artefacts whether it’s in their vial, for example, or the secondary packaging surrounding the vial.

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’ micromachining systems have been designed and built to machine a wide range of materials, including glass, plastics and metals. We are able to laser drill micro holes from 2µm to 100µm (and larger) into our customers’ samples to create calibrated positive control packages that are then placed into their quality control process for validation of their integrity testing system.  

When direct laser drilling into materials is not required, or not practical, Oxford Lasers provides precision pinhole stainless steel discs with certified holes down to 2µm. These precision-drilled pinhole discs can be affixed to packaging such as blister packs, plastic vials, and IV bags, sealing over a larger less precise hole that can be created by conventional piercing methods in the pack or container.

Employing the industry demands in current good manufacturing practices, Oxford Lasers currently supplies micron scale holes for CCIT and leak testing to pharmaceutical manufacturers, leak test equipment OEMs, as well as pharmaceutical and medical process consultants throughout the world.  We are a leader in precision laser-drilling of positive control packages used for test method development and validation.  Contact us today to help you with your CCIT positive control needs.