Blogs

As technological advancements lead to an ever-increasing world of routes of administration for new and existing drugs, packaging decisions for such options have become more challenging. There are multiple options for drug delivery container formats, and each should be continuously reviewed with reference to compliance and accuracy of delivery. Packaging is a critical point of concern whenever a new drug product is introduced into the market. When it comes to parenterals, there has been a dramatic increase in these packaging formats over the past 10 years. Apart from typical formats of vial and syringes, dual-chamber devices, cartridges and electronically enabled devices have been introduced, all which demand high levels of packaging accuracy. So how do we ensure the ability of the packages to maintain sterility of the drug? Quality assurance with the proper Container Closure Integrity Test (CCIT) method is critical.

CCI Testing using E-Scan 655 MicroCurrent HVLD

The E-Scan 655 technology utilizes the MicroCurrent conductivity test method to non-destructive evaluate container closure integrity. MicroCurrent technology exposes the package and product to lower voltage than other conductivity based solutions. This unique technology requires no sample preparation and is a non-contact and non-invasive test method. What makes E-Scan 655 technology unique is its ability to test a wide range of liquid-based products including low conductivity sterile water for injection (WFI) and proteinaceous products with suspensions. The system also features a fast test cycle and is simple to operate. Additional benefits include quick product changeover and an easy recipe set up to accommodate a wide range of products and applications. The offline E-Scan 655 method can be migrated from the laboratory to automated 100% inline testing applications at high production speeds.

Testing Procedure

Using a set of electrode probes, E-Scan system tests a non-conductive container that is sealed. The container material can vary from glass, plastic, or poly laminate. The container or package must contain liquid (minimum fill 30%). In case of any defect including pinhole or crack, there will be a resistance differential and change in current flow indicating a breach in the container. The approximate defect location can be identified.

Benefits of MicroCurrent HVLD technology:

• Non-destructive, non-invasive, no sample preparation
• High level of repeatability and accuracy
• Effective across all parenteral products, including extremely low conductivity liquids (WFI)
• Lower voltage exposure produces no ozone, eliminating risk to the product and environment
• Listed in USP Chapter <1207> as recommended method for parenteral liquid package integrity testing
• Robust method and approximate 3x Signal-Noise-Ratio for a wide range of product classes and package formats
• Simplifies the inspection and validation process