Blog

Bubble Leak Testing for Pharmaceutical Products

14 February 2022

Bubble Leak testing is a method of detecting leaks in sealed packaging by visually inspecting them against changes in pressure.

 

This process is used to asses the integrity of packaging’s seal and the integrity of the sterile barrier before and during releasing the final products on the markets.

 

There are several industries that require Bubble Leak testing such as:

✅ Pharmaceutical

✅ Food

✅ Automotive

✅ Military

✅ Transportation

 

Many defects can lead to leakage during the manufacturing and packaging of the product. That is why this test allows us to detect defects in the packaging before final production and shipment to the customer. This test allows us to test multiple forms of packaging, whether they are in a protective atmosphere or even in a vacuum.

 

Bubble Leak Testing is performed as follows:

1️⃣ The packaging is immersed under water in a specialised test chamber.

2️⃣ Medistri increases or decreases the pressure in the chamber to visualise the reaction of the product.

3️⃣ The pressure change in the equipment is done at a predetermined velocity.

4️⃣ The packaging is observed throughout the procedure. The observation is made by a steady stream of air bubbles that form if there is a failure zone on the product’s seal.

5️⃣ If a steady stream of bubbles is observed, it would indicate a breach of the sterile barrier.

 

For pharmaceutical products, Medistri routinely performs this test following ASTM F2096 (Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurisation (Bubble Test).

 

Medistri is also able to perform this bubble test according to the following other standards:

👉 ASTM D3078

👉 ASTM D4169

👉 ASTM D4991

👉 ASTM D5094

 

🎯 To learn more about our bubble leak testing services, visit our website www.medistri.swiss or contact our team directly at contact@medistri.swiss or here.

- The Medistri Team