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Over the years, major parenteral preparations and injections have been made in various packaging devices. The most popular ones include those that are used to contain lyophilized substances, such as vials and ampoules. However, there has been a dire need for devices such as ampoules leak detectors due to the chances of experiencing leakages.

Ampoules must be fully sealed since even the smallest opening can taint the sterile contents inside. Hence, an effective ampoule leak test procedure is very much essential for safeguarding the medications and sterile contents in an ampoule. If you are interested in learning how it works, stick around to find out!

What Is An Ampoules Leak Tester?

An ampoules leak tester is a device used to test for leaks in ampoules used for pharmaceutical and medical products. This device comes with added advantages for the food and pharmaceutical industries. If you are looking for a way to improve the safety of your product, a leak detector is definitely worth considering.

For those who aren't familiar with what an ampoule container is. It is a plastic or glassware in the form of a tiny single-dose vial with a sealed neck. In the laboratory, the neck is usually sealed with an open flame to avoid contamination. This results in an obstruction that is airtight, thereby preventing water, moisture, and air from contaminating the sample in it.

The Importance Of Ampoules Leak Detector

Nowadays, there are a lot of dangers associated with leaking samples, especially those used to package parenteral products. These dangers could be detrimental to the health of pharmacists and patients alike. Hence, there is a need for a leak-free container to work with.

An ampoule leak detector will always ensure that your ampoules are safe and effective for use. This will ensure they are not causing any harm or damage to patients. Additionally, this device offers numerous advantages to individuals and companies as a whole. Here are some benefits of this device:

-Extends the shelf life of products

-Protects against external contaminants

-Ensures accurate sample results.

●Extends The Shelf Life Of Products

Ampoules leak detectors are used by companies to detect the weak points of ampoules used while ensuring that high-quality ones are produced. These high-quality containers are hermetically sealed and will guarantee the sample's purity, thereby extending its shelf life. In other words, it will be ideal for diagnostic standards, lyophilization, and cryogenic storage.

The ampoule leak detection device is created to test numerous ampoules simultaneously. It uses a differential pressure method to find both large and small leaks.

●Protects Against External Contaminants

Ampoule leak detectors will ensure that you end up with a tamper-evident seal to guard against external contamination. Following health protocol and upholding industry standards for quality depends on this contamination-free container.

The ampule leak test procedures can also be used to test the quality of ampoules' seals before using them to package highly sensitive products. In a way, this device ensures the user's safety first by preventing cross-contamination and guarding against glass splinters.

●Ensures Accurate Sample Result

To get an accurate sample result, the closure of the container must be strong enough to prevent air ingress. This is why leak tests are carried out on ampoules to determine their quality before use. 

Ampoule leak detectors will ensure that damaged containers are marked out to prevent the risk of compromised samples. Then, you can be sure of a hundred percent accurate result with zero contaminants. That means, no air ingress and no product degradation.

How Does The Ampoules Leak Detector Work?

Certainly, leakage in ampoules will obviously affect the sterility and efficacy of the drug. Any damaged ampoule will pose a risk to the patient's safety since the substance will be injected directly into the bloodstream. This shows how far you need to double-check these containers before use.

Over the years, various systems and procedures have been developed for screening ampoule packages for leakage. However, the ampoule leak test procedure is the most widely used method. This procedure involves using a short vacuum chamber for testing the integrity of ampoules with various sizes.

The ampoule leak test procedure is a leak testing technique with high throughput and doesn't require human effort. This method is based on the high voltage test method and the electrical conductivity of the product contained in an ampoule. It uses a leak detection device to carry out in-line leak testing completely and automatically. 

If there is a leak, the discharged current will flow through the pinhole into the container. This container will instantly be rejected upon detection of this current. The ampoule leak detection device is made up of the following fundamental parts: 

  • Ampoule feeding systems to the leak detector

  • Product holders for the transport system

  • Switch for ampoule separation

  • Inspection electrode

  • Ampoule discharge system

  • Machine guards

  • Ozone exhaust system

  • Electrical panel with all electrical inspection devices

  • PLC and color monitor.

Ampoules Leak Detector For Pharmaceutical Industries

There is no doubt about it; ampoules are a vital tool in the pharmaceutical industry and other industries at large. In the pharmaceutical industry, they are used for packaging and transporting medications. They are a crucial part of any pharmacy's inventory but can be hazardous if they are not in proper condition.

Typically, products inside a leaking ampoule can be affected via microbiological contamination, gas exposure, water vapor exposure, and solvent loss. A small leak is just enough to destroy a good product. This whole phenomenon has resulted in the need for a well effective testing device.

In medieval times, vacuum-pressure treatment and methylene blue dye solution were used for leak-testing glass injectable ampoules. Up till now, this technique is still adopted by most testing devices. The ampoule leak detection device used today still works by means of a vacuum-pressure technique.

The ampoule leak test procedure can be used to create flexible ampoule cards that hold sterile pharmaceutical solutions. This can be incorporated into the production line for ampoule packages. 

Above all, it takes a modular approach to select the best leak detector for ampoule devices. If you are  experiencing any problem with your ampoule devices, do not hesitate to get in touch with us at or telephone number +370 689 24325. We offer the best leak detection service needed to test the integrity of your medical devices before use.

Ampoules Leak Detector



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