What is Container Closure Testing?
Container Closure Integrity Testing (CCIT), often known as leak detection, is an indispensable facet of packaging inspection. Its primary purpose is to maintain the aseptic barrier, crucial for preserving the sterility of pharmaceutical products.
Additionally, it requires confirmation that leak testing equipment is functioning optimally. This comprehensive validation process is widely recognized as CCIT (Container Closure Integrity Testing) or CCI testing. This protocol mandates the inclusion of positive controls or leak artifacts during test method development and validation.
Why is Container Closure Testing important?
Ensuring the integrity of the container closure is critical for maintaining the safety of pharmaceutical products. Without proper testing, there is a risk of contamination and loss of sterility of the product, which can lead to product recalls and harm to patients.
Leading regulatory bodies, including the European Medicines Agency (EMA) and the United States Pharmacopeia (USP), underscore the significance of Container Closure Testing by incorporating it into their guidelines for pharmaceutical manufacturing. Compliance with these guidelines is necessary for obtaining and maintaining product approval.
Container Closure Integrity testing methods
The choice of CCIT method depends on the specific objectives, such as measuring the container's overall leak rate, assessing the potential for microbial ingress, or detecting the presence of leak paths.
To conduct Container Closure Integrity Testing, it is essential to establish both positive and negative controls, considering various factors like design, materials, anticipated package leak characteristics and content. These controls are designed to replicate potential defects and are evaluated alongside intact samples.
One effective method for creating positive controls is through laser-drilled hole simulation. This approach maintains the sample's original geometry and closely mimics natural defects found in glass (such as cracks) and polymers (like microholes). Since natural leaks often follow meandering paths rather than forming perfect holes, the size of the simulated leak in the laser-drilled pinhole requires precise calibration.
Laser-drilled pinholes for Container Closure Integrity Testing
Leak Test Samples (LTS), or reference samples meticulously tailored for leak testing equipment, play a vital role in adhering to the stringent compendial requirements governing Container Closure Integrity Testing (CCIT) for parenteral products, aligning with industry standards such as the USP, EP and JP.
The key feature of eyetec’s Leak Test Samples is the presence of micron-sized pinholes, crafted with precision using state-of-the-art ultra-precision laser technology. Our advanced laser micromachining systems enable us to drill microholes ranging from 2µm to 100µm in various pharmaceutical containers such as glass vials, glass ampoules or cartridges carpoules, syringes, plastic vials, blister packs, IV bags, intravenous pouches, rubber stoppers and more.
Rely on eyetec for your CCIT needs
At eyetec, we are committed to meeting the stringent standards of good manufacturing practices (cGMP) set by the industry. We're your reliable source for Calibrated microholes crucial in CCIT and leak testing. As trailblazers in providing Positive Controls for test method development and validation, we're ready to support you with your CCIT needs.
Find out more about eyetec’s CCIT services and download our factsheet:
