Derived from USP 1207.1

There is no testing method for leak detection or packaging quality testing of intact packaging sealing parts that is applicable to all product packaging. Different product packaging polyps have different testing methods to choose from, and usually within a product lifecycle, multiple testing methods will be adopted. The selection of packaging testing methods and integrity considerations will be discussed in the packaging integrity testing of the product lifecycle. The selection criteria for other leak testing methods will also be widely discussed. The properties and approximate functions of the testing can be found in "1207.2" and "Packaging Integrity Leak Testing Techniques" for the selection of testing methods.

1. Packaging content

The nature of the packaging content is the first determining factor in the selection of leak testing methods. Whether the packaging contains liquid or solid components, whether there are inert gases, air, vacuum headspace, or no headspace, can all affect the selection of leak testing methods. For example, testing liquid packaging through vacuum attenuation or material extraction may lead to solidification in the leakage path of grass components, thereby blocking the flow of cold gases and causing the test to be ineffective. In this case, conductivity and capacitance tests can be used, but this test requires liquid products to be more conductive than packaging materials.

2. Different packaging designs, component materials, and mechanisms have different designs. Due to different component materials and mechanisms, packaging sealing will be affected, and each variable affects the selection of leak testing methods, as shown below

1) Rigid or flexible packaging, with no sub packaging, can withstand leakage testing under various pressures or under 100% air discharge conditions. The packaging technology shows that it has been fully filled with air to reduce toxicity, and some material extraction machines have been tested for gas. However, some flexible packaging openings need to be specially designed to prevent packaging expansion and seal damage in order to withstand different bed forces. In order to ensure that the pressure difference between the inside and outside of the packaging is consistent, Packaging needs to be restricted.

2) Mobile or fixed components

Flexible packaging components, such as syringes, may need to be fixed in most leak testing seats under different pressure testing conditions to prevent overall positioning (such as tracer testing pressure drop or direct air drop test substance oil extraction test fluid bubble test and microbial immersion challenge test)

3) Under real testing conditions, packaging materials such as plastic boxes and bullet bodies may release volatile substances, which can improve the vacuum penetration test results and material extraction results, resulting in incorrect packaging leakage test results. Plastic packaging with high permeability components for tracer gases may not be compatible with helium tracer gas leakage detection, as hydrogen permeation from the packaging can produce incorrect results. For example, being mistaken for packaging leaks or potentially masking small leaks. A special fixed device used to limit the permeation effect of tracer gas and isolate the tracer gas from the sealed area to be measured has been used to alleviate these difficulties. 4) Packaging made of metal materials made of aluminum foil spreading material may not be compatible with conductivity and capacitance leakage detection, as this leakage method is most effective for packaging materials that are relatively non-conductive. However, the aluminum cap that fixes the elastic seal of the injection bottle will not hinder conductivity and capacitance testing, and the leakage point should be located between the seal and the injection bottle mouth in a timely manner.

5) Transparent or opaque materials. Transparent or semi transparent packaging allows for visual inspection or electromagnetic waves to pass through. Therefore, transparent or semi transparent materials can be tested using laser gas headspace analysis technology and tracer liquor intrusion or microbial intrusion methods. Opaque packaging cannot be tested using methods that require visual inspection of the packaging content.

3. For a discussion on the classification of seal types represented by various product packaging systems, please refer to (1207) Evaluation of Complete Components of Aseptic Product Packaging for food seal types and mechanisms. The design of the seal system and its leak prevention function (i.e. maximum allowable leakage), as well as the expected defect types, will all affect the selection of integrity testing methods.

4. Maximum allowable leakage speed

1) It is necessary to maintain sterility and product formula content, and there is no requirement to maintain gas headspace. Tracer gas testing using vacuum mode and laser gas headspace analysis testing methods are two examples of this type

2) It is necessary to maintain sterility, product formula content, and gas headspace content. For this type of product quality, leakage testing options include direct inspection of packaging headspace pressure and content, such as laser based gas headspace analysis technology

3) It is necessary to maintain sterility. Disease requires products to be used multiple times. The classification of product quality refers to those products containing multiple doses of packaging that, once used by the end user, require additional requirements for the integrity of the used packaging. The self sealing test mentioned in functional testing is a blue dye tracer test, aimed at detecting whether the seal can maintain sealing after puncture and preventing large amounts of liquid leakage.