"The experts at CTC work individually with each customer to help determine the right test method for their respective system.” said Sandy Almassou, Laboratory Manager, Cryopak Testing Center.
EDISON, N.J. (PRWEB) April 17, 2018
Cryopak announced today it is now offering deterministic Container Closure Integrity Testing (CCIT) methods at its Cryopak Testing Center (CTC) located at its headquarters in Edison, NJ. CCIT, as outlined in USP 1207, is a viable alternative to sterility testing of parenteral drug product or biologics. Container closure integrity (CCI), is defined as the ability of a container closure system to provide protection and therefore maintain the efficacy and sterility of a product throughout its shelf life.
“Container closure integrity testing can be performed using deterministic or probabilistic methods. Choosing the right method depends upon the container system being evaluated,” said Sandy Almassou, Laboratory Manager, Cryopak Testing Center. “The USP 1207 guidance document recommends the use of deterministic methods against probabilistic methods whenever possible, as they are less subject to error and provide quantitative results. The experts at CTC work individually with each customer to help determine the right test method for their respective system.”
The four deterministic CCIT methods the CTC will offer include:
- Tracer Gas Detection, Vacuum Mode (Helium Mass Spectrometry) – a deterministic test used to detect and locate small leaks for non-porous packaging such as vials, syringes, cartridges and flexible packaging.
- High Voltage Leak Detection (HVLD E-Scan 655) – a deterministic MicroCurrent conductivity test that is non-destructive which is ideal for testing vials, syringes, cartridges and other liquid filled containers and plastic bags or pouches.
- Frequency Modulation Spectroscopy (Headspace Analysis) – a deterministic, non-destructive gas analyzer for monitoring headspace concentration in sealed containers.
- Vacuum Decay – a deterministic, non-destructive test that is used to measure and verify container closure integrity of the package system by identifying package leaks that may not be visibly detectable.
Cryopak will be showcasing its CCIT capabilities along with its package and product testing capabilities in booth #1460 at the Interphex conference being held April 17-19 at the Javits Center in New York City, and in Booth #345 at the BIOMEDevice Boston conference being held April 18-19 at the Boston Convention & Exhibition Center.
Cryopak, a subsidiary of TCP Reliable, is a cold chain solutions provider for the pharmaceutical, life sciences, biotech and food industries. The company manufactures items for temperature-sensitive shipping needs, including insulated shipping containers, gel packs, phase change materials and temperature monitoring devices, and also offers package design and testing services in its ISTA certified lab. Cryopak delivers superior products and service from an industry-leading team of experts whose primary goal is to ensure and protect product integrity.
Cryopak is headquartered in Edison, New Jersey, with locations across the United States, Canada and France. TCP Reliable is the world’s leader in first mile-last mile temperature assurance packaging and testing.