PTI’s technologies are the most sensitive and most reliable solutions for pharmaceutical and biotech packaging applications where the results have a significant impact on stability studies, clinical trials, production performance and patient safety
When assuring the quality of all packaged products, container closure integrity testing (CCIT) is critical, especially for parenteral products. If there is a breach in the seal, even a microscopic defect, it affects the sterility and the stability of the products – the drug may not be as effective due to oxidation or moisture ingress impacting the active ingredient.
More importantly, a sealing or closure defect can lead to patient safety concerns. Parenterals are sterile preparations intended to be administered directly into the system circulation in humans or animals. A compromised parenteral container can act as a vehicle for microbial transmission and pose a significant risk to the patient.
PTI’s solutions cover container closure integrity from the R&D Laboratory to fully automated solutions for production and manufacturing.
E-Scan MicroCurrent HVLD technology can be used to quantitatively detect leaks without destroying the sample. When it is applied to a non-conductive package material that contains a semi-conductive product inside, a spike in the voltage reading would indicate a defect in the packaging. MicroCurrent technology can be applied for containers with liquids including proteinaceous products, products with suspensions or emulsions and sterile water for injection (WFI).
Vacuum decay is another deterministic technology that is known to provide reproducible and reliable results for CCI testing of high-risk package applications. The ASTM Test Method F2338 was developed using PTI VeriPac instruments and is also an FDA recognized standard. The test involves placing a package in a test chamber, applying vacuum, and monitoring the vacuum level for any change, which would indicate the presence of a leak.
Scalable CCI solutions from Laboratory to Automated Production Inline Testing
With PTI’s decades of experience and expertise in providing CCI solutions to the pharmaceutical and biotechnology industries, we understand the challenges and are ready to support you. We help to design a strategy for CCI testing according to regulatory requirements.
Our benchtop laboratory systems are scalable to fully automated testing on the production line and at-line small batch testing.
Helium Leak Detection and Low Temperature/Cold Storage Package Test Solutions
Complex drug and biologic formulations have resulted in a continuous drive toward deeper cold storage in an effort to maintain product quality attributes, requiring life science companies to drive toward deeper cold storage. Since these products are often cell or gene or proteinaceous in nature, they are required to be stored at below -20°C, and also needs storage and distribution environment that include dry ice (~-78.5°C), or even liquid nitrogen (~-200°C).
While the products demanding such intense cold storage may be complex, oftentimes, the package systems in which the products are placed are rather traditional in nature, such as a screw or crimp top vial. However, at these temperatures, many of the materials used in these package systems and responsible for maintaining package integrity are not typically assessed at these temperatures. When such packages are exposed to deep-cold or ultra-cold temperatures, materials reach or exceed their glass transition state. This particularly causes physical changes to elastomeric components and creates leaks at low temperatures that would otherwise not be observed while at room temperature. Common areas where such type of leakages are observed include primary seal areas, primarily between an elastomeric closure and glass vial being used below -60C. If manufacturers are able to test container closure integrity while at these low temperatures, they gain a number of benefits with regard to optimal package choice and design, assembly parameters, minimizing leakages as well as have a clear understanding of a package system’s performance in accordance with USP 1207.
PTI offers a line of low temperature add-on options that enable helium leak testing to as low as -150C for individual package samples. When using helium as a tracer gas, packages can be quantitatively tested to levels far exceeding bubble and dye penetration tests, pressure decay, mass extraction, and high voltage leak detection. The LDA systems follow the guidelines set forth by the USP 1207 general chapter test requirement and more specifically by ASTM F2391-05, standard leak test method for helium technology.