Leak Testing in the Pharma Industry: Why is it important?


Leak Testing Pharma Packaging

Pharmaceutical products can be extremely delicate and need to be kept sterile.  It is important that packaging for pharmaceuticals is of the highest standards as the packaging does not only affect the brand, but faulty packaging can also become a health and safety issue. By including leak testing in pharma production and packaging, you can ensure that your products are reaching end consumers without spoilage, contamination, or deterioration. This article will explain why package seal integrity and leak testing are important in the pharmaceuticals industry, and why is the best choice to ensure your product has a proper, airtight seal. 

Flexible Testing Options Comply with Industry Regulations

There are some unique challenges that are faced by the pharmaceutical industry when designing and testing packaging.  Firstly, the pharmaceutical industry is strictly regulated, and as such must undergo specific testing requirements at different stages of the packaging process. Secondly, due to the nature of pharmaceutical products, a variety of different packaging types are needed, even when dealing with similar products. Pills, for example, could be contained within individually sealed blister packs or in airtight bottles, depending on the medication’s ingredients and corresponding regulations. It is important that leak testing equipment must be accurate, versatile, and able to perform different types of tests on a variety of packaging types.  

High Sensitivity Testing Detects Miniscule Leaks

Another challenge that pharmaceuticals face is the need for sensitive testing.  Due to both regulations and safety concerns, pharmaceutical products must be tested at a much more sensitive level than other products, such as food or beverages. Contamination from bacteria, other organisms, chemicals, or elements (even air!) can compromise a product’s sterility, effectiveness, and even safety. The  Internal Pressurization Assembly (FPIPA) allows users to perform ASTM Testing Standard F2096, which has an increased sensitivity and can detect micro leaks that are normally undetectable by a standard bubble emission test.  This increased sensitivity makes it ideal for pharmaceutical manufacturers who must keep products sterile, and whose packaging could be compromised by the smallest leak.   

Prevent Contamination to Ensure Health & Safety

Finally, it is important that pharmaceutical products reach consumers in their manufactured condition, as they may otherwise be deemed unsafe for use or rendered ineffective. While some pharmaceuticals have a long shelf life and will be effective after prolonged exposure to air, this is not the case in all circumstances – pharmaceutical products often have a short half-life, losing their effectiveness quickly. Other products may be unsafe when exposed to air, which could allow microorganisms such as bacteria to penetrate sterile materials or cause adverse reactions when brought into contact with air.  Leak testing is crucial to ensure that pharma products are not losing effectiveness or becoming contaminated prior to use. Failing to conduct proper leak testing could lead to harmful results for consumers and patients. 

Test Methods 

Package Leak Detectors provide several leak testing solutions to suit your needs within the pharma industry. As different products require different testing conditions, ’s diverse seal integrity tests can ensure your packages meet the required ASTM testing standards. 

Bubble Leak Testing: Bubble Leak Testing is completed in an acrylic vacuum chamber.  The sealed product is submerged in water and, when put under pressure, bubbles will form at any compromised points in the packaging.  Bubble Leak Testing is an easy visual test that will ensure your packaging’s integrity while adhering to the ASTM D3078 testing standard.

Detecting Gross Leaks In Packaging By Internal Pressurization: The ASTM F2096 Testing Standard provides highly accurate testing for pharmaceutical and medical packaging, allowing users to detect leaks, substrate holes, and channels accurately and reliably.  The sensitive nature of this test means it can detect leaks that a standard Bubble Leak test cannot, and it can also be used with a variety of package shapes and sizes. 

Altitude Simulation Testing: Altitude Simulation testing, the ASTM D6653 testing standard, is a package integrity testing method that simulates the extreme pressure changes a package may undergo during transport. An altitude test will simulate ascent and descent rates, as well as a set altitude for an extended period of time, ensuring that the packaging can withstand its transport and reach consumers intact.  

Dry Chamber Tests: A Dry Chamber Test is performed without liquid in a leak detector tank.  This procedure is best suited for packages containing liquids, such as condiment sachets or bottles with lug-style and threaded caps.  The package is placed within the chamber on an absorbent material and, when put under pressure, any leaks will result in the presence of liquid within the dry tank. The ASTM D5094 testing standard is performed in a dry tank environment. 

Leak testing is an important step in the manufacturing process, and can help to ensure that pharmaceuticals and medical products are maintaining their integrity until they are ready for use. offers custom solutions to ensure your packaging is at its best and can work with you to find the best equipment to meet your needs.  

From Fruit to Pharmaceuticals, Meat to Medicine, and anywhere in between, is the most reliable solution when it comes to package seal integrity and leak testing equipment.  Contact us now at (416) 399-5583 or visit us at https://flexpakinc.com for more information or to request a quote.  

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