Revolutionizing CCI Testing - Vacuum Decay for Vial package Integrity

Package integrity testing is a crucial aspect of pharmaceutical manufacturing to ensure product safety and efficacy. One of the most common packaging formats in the pharmaceutical industry is vials, which are used for a wide range of products, from vaccines to injectable drugs. Ensuring the integrity of vial packages is paramount to prevent contamination and product degradation. Traditional methods of CCI testing can be time-consuming, labor-intensive, and may not provide the necessary sensitivity for detecting subtle defects. In recent years, Vacuum Decay technology has emerged as a promising solution to revolutionize CCI testing for vials.

Vials: Challenges and Applications

Vials are versatile packaging formats with numerous applications in the pharmaceutical industry. However, they also present unique challenges for ensuring package integrity. Vials are often made of glass, which can be susceptible to cracks or delamination. Additionally, the sealing process, typically involving the use of rubber stoppers and aluminum crimps, can introduce potential defects. Ensuring the integrity of vial packages is critical to prevent contamination, product leakage, and degradation, which can have serious consequences for patient safety and product quality.

CCI Testing: Liquid vs. Lyophilized Products

When it comes to CCI testing for vials, it's important to distinguish between liquid and lyophilized (lyo) products. Each type presents unique challenges. Liquid products require a tight seal to prevent leakage and contamination, while lyophilized products must maintain integrity to ensure the stability of the dehydrated formulation. Traditional CCI testing methods such as dye ingress, pressure decay, and helium leak detection have their limitations, particularly in sensitivity and speed. Vacuum decay can be utilized for CCI of both liquid filled and lyophilized vials, making this technology a versatile all-around solution.?

CCI Testing Using Vacuum Decay Technology

Vacuum Decay is a test method that has been proven over decades as the most practical and sensitive vacuum-based leak test method. It is a simple test method that challenges container integrity based on fundamental physical properties. Vacuum Decay technology creates reliable and accurate quantitative results with a pass or fail determination and has been established as a non-destructive deterministic alternative method to the blue dye test. The standard vacuum decay leak test method (ASTM F2338), developed using PTI's VeriPac instruments, is recognized by the FDA as a consensus standard for container closure integrity testing. The test method is referenced in the United States Pharmacopeia Chapter on CCI (USP Chapter 1207)

Under this method, the leak testers are first connected to a test chamber that is specifically designed to hold the package to be tested. Vacuum is applied to the package placed inside the test chamber. Using single or dual vacuum transducer technology test chamber and level of vacuum are monitored along with a change in vacuum over a predetermined test time. The changes in absolute and differential vacuum indicate the presence of leaks and defects within the package. This inspection method is suitable for laboratory offline testing and can be designed for manual or fully automated operation. The test cycle is non-destructive to both product and package and takes only a few seconds. It provides significant savings by not wasting products for a leak test and generates a rapid return on investment.

Key Benefits of Vacuum Decay technology

·???????? Non-destructive and non-invasive, deterministic test method

·???????? No sample preparation

·???????? ASTM approved test method

·???????? FDA Recognized Consensus Standard

·???????? Allows for increased sampling

·???????? Quantitative results

·???????? Repeatable

·???????? Rapid test time

·???????? Eliminates cost and waste of destructive testing

·???????? Test results can be easily validated

·???????? SPC laboratory testing or online applications

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