Addressing Challenges in Leak Testing for Cold Chain and Terminally Sterilised Products

Leak testing for cold chain and terminally sterilised products presents unique challenges due to factors such as condensation and entrapped moisture, which can compromise the accuracy of traditional detection methods.

Challenges Posed by Condensation and Entrapped Moisture

Cold chain and terminally sterilized products are particularly susceptible to moisture-related issues during leak testing:

1. Condensation in Cold Chain Products

Many injectables including vaccines and biologics require stringent temperature control throughout storage and distribution. 

When these products transition from cold environments to ambient conditions, condensation may form on or within the packaging. This moisture can:

• Interfere with vacuum decay based testing methods.
• Create false rejects by mimicking leak signatures.

2. Entrapped Moisture in Terminally Sterilised Products

Terminal sterilisation processes, such as steam sterilisation, involve high-pressure steam to ensure sterility. This can result in moisture retention within packaging components again leading to false rejects by mimicking leak signatures.

Wilco’s Non-Destructive Leak Testing Solutions

Wilco AG offers advanced Container Closure Integrity Testing (CCIT) solutions tailored to specific packaging requirements and leak sensitivity levels. Their platform accommodates various packaging formats, including ampoules, vials, blow-fill-seal (BFS) containers, ophthalmic containers, pouches, flow wraps, and IV bags, ensuring precise integrity testing across diverse product types.

Wilco’s technologies are engineered to achieve low false rejection rates and high-test efficiencies. 

Their solutions effectively address the challenges posed by condensation and entrapped moisture in cold chain and terminally sterilized products. For containers of oncological and hormonal products, Wilco provides solutions that minimise operator exposure during testing.

Summing Up

Leak testing for cold chain and terminally sterilised products necessitates specialised solutions to overcome challenges associated with condensation and entrapped moisture which Wilco delivers with precision thereby reducing false rejections and optimising costs while upholding the highest standards of packaging integrity.

For more information, please contact us at [email protected] or +91 98211 11623.