ASTM F1929-23: Seal Leaks In Porous Medical Packaging

Dentist hands in white sterile gloves holding dental tools for surgical use packed in a protective foil that adheres to ASTM F1929-23 medical packaging requirements.

Products in pharmaceutical industries are prone to spoilage, and leaks in the packages or bottle seals can lead to air penetration, making the product unsafe for consumption. Since harmful biological or particulate contaminants may enter the medical package through leaks (typically found at seals), it is critical to assure package integrity and seal strength via medical package leak testing. ASTM F1929-23: Standard Test Method For Detecting Seal Leaks In Porous Medical Packaging By Dye Penetration provides test methods to observe the presence of channel defects by the leakage of dye through them.

What Is ASTM F1929-23?

The test method in ASTM F1929-23 defines materials and procedures that detect and locate a leak equal to or greater than a channel formed by a 50 µm (0.002 in.) wire in package edge seals formed between a transparent material and a porous sheet material. Since these test methods are designed to detect leaks, components that exhibit any indication of leakage are normally rejected. Upon testing, a dye penetrant solution is applied locally to the seal edge of a package to be tested for leaks. After contact with the dye penetrant for a specified time, the package is visually inspected for dye penetration.

Leak Testing in the Pharma Industry: Why Is It Important?

It is important that packaging for pharmaceuticals is of the highest standards because faulty packaging can become a health and safety issue. By including leak testing in pharma production and packaging, pharma industries can assure that their products are reaching end consumers without spoilage, contamination, or deterioration. Even the smallest leak in these products can lead to contamination, moisture buildup, and even damage to the product itself, compromising the safety and efficiency of these products. The leak testing method is applied to all types of pharmaceutical packaging like pouches and sachets, packs, and flexible or rigid containers.

Primary packages, for example, come into close contact with drugs and include vials, ampoules, blister packs, and prefilled syringes. Pharma industries combine drugs and medicine with boxes, cartons, and injection trays to ease shipping. As a result, pharma companies should conduct leak tests to prevent cross-contamination and ensure the drugs are safe. Leak testing equipment must be accurate, versatile, and able to perform different types of tests on a variety of packaging types. This test enables products to safely reach the consumers in the intended state.

Types of Medical Packaging Testing

Packaging in pharmaceuticals and medical varies depending on the product—ranging from IV sets, catheters, pills, respiratory devices, wound drainage systems, etc.  Different packaging materials offer varying degrees of barrier protection. As such, it is essential to choose the right material based on the specific requirements of the medical device or product.

Another important aspect to consider when selecting medical packaging materials is sterilization. Different materials have varying levels of resistance to sterilization methods, which assure medical devices and products are free from contaminants and safe for use. The packaging material must be compatible with the chosen sterilization method, such as gamma radiation, ethylene oxide (EO), or a steam autoclave because this compatibility assures that the packaging maintains its integrity and protective properties after undergoing the sterilization process.

Dye Penetration Test Methods in ASTM F1929-23

Three dye application methods are covered in ASTM F1929-23: injection, edge dip, and eyedropper. These test methods are for use on packages with edge seals formed between a transparent material and a porous sheet material. They are limited to porous materials which can retain the dye penetrant solution and prevent it from discoloring the seal area for a minimum of 5 seconds. Uncoated papers are especially susceptible to leakage and should be evaluated carefully for use with each test method. These test methods require that the dye penetrant solution have good contrast to the opaque packaging material.

ASTM F1929-23: Standard Test Method For Detecting Seal Leaks In Porous Medical Packaging By Dye Penetration is available on the ANSI Webstore.

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