DDL, Inc. has implemented a GMP compliant quality system at its Irvine, CA laboratory to govern its container closure integrity testing (CCIT) division.

Container closure integrity testing is a process of evaluating the effectiveness of the seal or closure of a container in maintaining the sterility and stability of a product. CCI testing is crucial in ensuring the quality and safety of the packaging for pharmaceutical products, as any breach in the container’s integrity can compromise the product’s stability and sterility.

The company said that with the addition of the new quality system, DDL is now able to perform CCI testing on sterile package systems for parenteral drug and biologic products that meet GMP regulatory requirements.

“As the pharmaceutical industry technologies advance, particularly with sterile package systems and novel administration methods, ensuring our quality management system meets or exceeds the industry requirement will provide a higher degree of confidence and reliability for our customer’s regulatory submissions and filings,” said Michael Dominguez, DDL/CCIT program manager. “Having a quality system that harmonizes with the multiple regulatory bodies across the globe will help ease the navigation and approach to the regulatory challenges our customers are facing, and ultimately instill a higher value of service for their programs.” 

DDL will highlight its CCI testing, as well as its package, medical device and material testing service offerings in Booth #1253 at the INTERPHEX conference April 25-27 at the Javits Center in New York.