Container Closure Integrity Testing (CCIT)

Preserving the safety, stability, and regulatory compliance of pharmaceutical and healthcare products largely relies on efficient packaging systems. Container Closure Integrity Testing (CCIT) is an essential process that verifies if a container system can maintain its protective covering against environmental factors such as moisture, oxygen, and light. At Chromak Research, we provide comprehensive container qualification testing services to support clients in satisfying regulatory expectations as well as patient safety.

USP <671> offers the functional needs of the packaging systems utilized in solid oral dosage forms (SODFs) and liquid oral dosage forms (LODFs). Its use, however, does not just stop there and is highly relevant to other types of products.

Two of the most important components for USP 671 permeation testing are:

Water Vapor Transmission Testing (Permeation): Verifies packaging gives required moisture protection.

Spectral Transmission Testing (Light Resistance): Tests light protection for “light resistant” marketed packaging.

Several types of containers are addressed by USP <671>, including:

Multiple-dose containers (bottles, closures)

Single-unit containers (stick packs, blister cavities)

Unit-dose containers (blister cards with more than one cavity)

USP has permitted a number of new test procedures, while leaving some criteria open-ended to provide manufacturers with options to choose the most appropriate container for their product.

The Chromak Research team has been testing closure integrity in containers for many years and can provide a customized test plan specific to your particular container system, product type, and regulatory needs.

Also referred to as “light percent” testing, spectral transmission measures the quantity of transmitted light from packaging systems. In the case of plastic containers requiring light-resistance, we apply advanced UV-Visible Spectrophotometry via specific equipment to measure light transmission quantitatively. This is crucial in plastic packaging systems to validate regulatory requirements.

The USP <661.1> and <661.2> sections regulate testing of plastic components used for pharmaceutical packaging.

These new specifications also brought higher safety and performance levels for packaging materials.

Chromak Research can offer USP 661.1 testing and USP 661.2 testing, utilizing cGMP-certified, FDA-registered laboratory services.

Pharmaceutical packing material qualification services are offered by Chromak Research to meet international standards. These include:

USP <671> Permeation of Containers and Moisture Vapor Transmission Testing

USP <659> Storage and Packaging Requirements

USP <661.1> Construction Plastic Materials

USP <661.2> Pharmaceutical Plastic Packaging Systems

USP <661.3> Plastic Materials Used in Pharmaceutical Manufacturing Systems

USP <670> Package Parts Auxiliary Packaging

Our hands-on experienced research scientists create customized test plans that address customer specifications and regulatory issues, as per FDA, USP, and international guidelines.

ISO 17025:2017 accredited and FDA-licensed laboratory

Sound qualification testing experience of containers

Advanced analytical instrumentation, including UV-Vis spectrophotometry, HPLC, GC-MS, ICP-MS, and stability chambers

Extended method development, validation, and regulatory submission service

Proven ability to reduce compliance risk and avoid costly product recalls

Whether you are developing a new drug product or qualifying packaging for regulatory submission, Container Closure Integrity Testing is the key to product success. At Chromak Research, we combine technical expertise, state-of-the-art facilities, and familiarity with regulations with an unwavering dedication to providing accurate and reliable results.

Partner with us to get your packaging systems up to par with the world standards of quality, safety, and performance.