Esco Aster offers Container Closure
Integrity Testing (CCIT) as a standalone contract testing service per USP 1207
and ASTM or and as an integral component of our integrated Drug Product Fill
& Finish capabilities.
Our CCIT programs begin with a
comprehensive assessment of the client's primary and secondary packaging
systems, including a review of the Drug Product Quality Target Therapeutic
Profile and intended product application.
Based on these requirements, we determine
the most suitable integrity testing methodology and design a customized test
solution tailored to the specific container closure system.
To support method development, our in-house
engineering team develops a detailed Statement of Work (SOW) outlining the
design, fabrication, and qualification activities required.
Custom container holders and test chambers
are engineered and manufactured in-house for vacuum-decay using PTI VeriPac
465, based on the ASTM F2338-09 Triple-Cycle Vacuum Decay method. This
technique detects molecular, micro, and large leaks.
Prototype test chambers are typically
produced using 3D printing technology to verify dimensional accuracy and
container fit prior to fabrication of the final testing apparatus.
Following completion of the custom test
chamber, Esco Aster proceeds with method development, optimization,
qualification, and validation of the selected CCIT method for the client's
container closure system.
Studies are conducted in accordance with
applicable regulatory expectations and industry best practices to demonstrate
the integrity and suitability of the packaging system including ICH Q2:
Validation of analytical procedures to validate CCIT key parameters including
accuracy, precision, and detection limit.
Upon completion, a comprehensive technical
report is provided, documenting the method development, qualification,
validation, and testing outcomes. This documentation may be used to support
regulatory submissions, including IND, BLA, NDA, and other global health
authority filings.
USP 1207 Sterile Product – Package Integrity Evaluation Introduction
1207.1 Package Integrity and Test Method Selection
1207.2 Package Integrity Leak Test Methods
1207.3 Package Seal Quality Test Methods