--> --> -->


Apr 2024

Feasibility Studies for Package Quality Testing

Feasibility Studies for Package Quality Testing

Package integrity testing plays a crucial role in ensuring that products are delivered to consumers in optimal condition. A package is not merely a container; it serves as a protective barrier against various external factors that could compromise the product's quality and safety.

Package integrity testing involves assessing the ability of packaging materials to maintain product quality and safety throughout the distribution chain. It encompasses various techniques and methods aimed at detecting any defects or vulnerabilities in packaging that could lead to product contamination, spoilage, or damage. It typically includes evaluating factors such as seal strength, leak detection, burst strength, and microbial barrier properties. These tests are essential for ensuring compliance with regulatory standards, meeting consumer expectations, and safeguarding brand reputation.

Why Consider Feasibility Studies for Package Quality Testing?

CCIT offers specialized expertise in the application of deterministic inspection technologies and test methods to assess the integrity of various packaging formats. An initial step in this process involves conducting either an experimental or a more comprehensive feasibility study to evaluate and determine the most suitable Container Closure Integrity (CCI) technology and test method for a specific application. The primary objective of such feasibility studies is to assess the efficacy of a recommended CCI solution and establish optimal test parameters, including the Limit of Detection (LoD). These studies are conducted in accordance with established standards such as USP 1207, ASTM, and ISO to ensure compliance with regulatory requirements, notably those set forth by agencies like the FDA.

The results obtained from these studies can be seamlessly integrated into production environments for rapid validation and deployment. Various test methods are available to assess and ensure package quality and performance, with the primary goal of identifying the most optimal inspection technology that yields accurate, sensitive, and reliable data for comprehensive package integrity verification.

Upon completion of a feasibility study, clients receive a detailed report outlining a quantitative test method tailored to their specific package format. This report encompasses the validation of the recommended approach, leveraging known good test samples and positive controls with predefined defects to establish the test method and confirm the Limit of Detection.

PTI is committed to delivering deterministic package integrity testing solutions to its customers, guiding them through the implementation of comprehensive CCI systems, and providing ongoing after-sales support and periodic certification mandated by regulatory bodies.

In conclusion, feasibility studies by PTI-CCIT are crucial for determining the most effective container closure integrity (CCI) solutions. Through meticulous assessment of inspection technologies and adherence to standards like USP 1207 and ASTM, PTI ensures clients receive compliant and tailored package integrity testing solutions. The detailed reports empower informed decision-making, enhancing product quality and regulatory compliance.

package integrity testing, container closure integrity testing, container closure integrity

Popular Blogs


CCIT for Pharmaceutical Package Integrity

Jul 23, 2021   |   2734

Container Closure Integrity Testing of pharmaceutical packaging ensures that the products remain intact throughout its shelf life or until it reaches the end user.

Why is Seal Integrity Testing of Medical Device Packaging Important

Jul 29, 2021   |   2472

For sterile medical devices, seal integrity testing ensures product efficacy, shelf-life stability, and microbial sterility. Airborne Ultrasound technology is a non-destructive Container Closure Integrity test method, capable of examining seal quality for defects.

A Guide to MicroCurrent HVLD Technology

Aug 05, 2021   |   2377

In the case of parenteral drug product containers, HVLD technology is ideal for CCI testing in cases where packaging is less conductive than the liquid within.

Pre-filled Syringes Leak Detection with Vacuum Decay Vs MicroCurrent HVLD Test Methods

Nov 23, 2021   |   2064

Container Closure Integrity (CCI) can be challenged using various test methods, not all of which are equally capable of detecting leaks in the package.

Evaluating Package Integrity Solutions for Vials

Nov 30, 2021   |   2063

CCI testing is a critical component of quality assurance for vials. The defects which cause a sterile vial to leak are not necessarily defects that will be detected.