Calibrated microapertures for container closure integrity testing (CCIT) aid in the validation of packaging processes.

Leak testing is a critical part of any pharmaceutical packaging line. Pharmaceutical standards such as USP 1207 and EU Annex 1 require that packaging be definitively leak tested and that leak testing equipment be confirmed to be functioning properly. These processes are often referred to as CCIT (Container Closure Integrity Testing) or CCI testing and require positive controls.

Positive controls are created by drilling a known, measured microscopic hole in the package. These are used during production to provide definitive proof that the leak tester is operating properly.

Shanghai Qiyi Instruments has a large number of laser micromachining systems that are designed and manufactured to process a variety of materials, including challenging materials such as glass and plastic. As a result, we are able to drill micro holes as low as 1 micron in glass bottles, glass ampoules, plastic bottles, blister packs, bags and other pharmaceutical containers. Our systems are also able to drill holes in different locations in the packaging, such as the neck, bottle body or vial bottom.

Shanghai Qiyi Instruments currently provides micro-apertures for CCIT and leak testing to pharmaceutical end users and pharmaceutical and medical process consultants. Call us to help you with your CCIT needs.