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Ampoule Leak Test

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Ampoule Leak Tester

An ampoule leak test is essential for detecting defects in sealed glass vials that may cause leakage. Since ampoules store sensitive products like vaccines, antibiotics, and cosmetics, ensuring their integrity prevents contamination, spoilage, and loss of efficacy.

Standard

ASTM F2338，USP 1207

Product Features

Detects micro-leaks accurately
Non-destructive testing
Easy touchscreen operation
Automated process
Complies with USP, ASTM, GMP

Principle

Principle of Vacuum Decay Method:

Placing the Ampoule into the Sealed Test Chamber
The ampoule is placed inside a sealed testing chamber, which is designed to maintain a vacuum environment.
Evacuating the Test Chamber
A vacuum pump removes the air from the chamber, creating a low-pressure environment.
Pressure Stabilization Stage (Equilibrium Phase)
Once the desired vacuum level is reached, the system maintains a stable pressure for a set period to observe any changes.
Monitoring Pressure Changes

- If the ampoule is properly sealed: The pressure inside the chamber remains stable without significant fluctuations.
- If the ampoule is leaking: Air enters the ampoule through the defect, causing further pressure drop or fluctuations in the chamber, indicating the presence of a leak.

Technical Parameters

Test Range	1Pa
Sensitivity	1~3μm
Chamber size	Made-On-Demand
Vacuum pump	to be prepared by user
Power Supply	AC 110~220V 50Hz

Common Ampoule Leak Testing Methods

Test Method	Principle	Applicable Scenarios	Advantages	Disadvantages
Vacuum Decay	The ampoule is placed in a sealed chamber, vacuum is applied, and pressure drop is monitored to detect leaks.	Routine quality control, inline testing	Non-destructive, high sensitivity, automation-ready	Relatively high equipment cost
Pressure Decay	Positive pressure is applied to the ampoule, and pressure change over time is observed to identify leaks.	Suitable for rigid containers	Simple operation, compatible with various containers	Lower accuracy compared to vacuum decay
Dye Penetration	The ampoule is immersed in dye solution and pressurized; dye intrusion indicates leakage.	Lab sampling, low-cost testing	Low cost, intuitive method	Destructive, subject to human error
Helium Leak Detection	Helium is applied to the ampoule; in vacuum, escaping helium is detected to identify microleaks.	High-end pharmaceutical, R&D use	Extremely high sensitivity, detects microleaks	High cost, complex operation

Usage Precautions

Please read the user manual and safety instructions carefully before operating the device.
Keep the equipment clean and prevent liquids or dust from entering the test chamber.
Perform regular calibration to maintain testing accuracy and reliability.
Do not exceed the specified ampoule sizes or pressure ranges recommended by the manufacturer.
In case of any abnormalities or malfunctions, contact the manufacturer’s after-sales support promptly.

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Ampoule Leak Test Importance

Container Closure Integrity Testing pharmaceutical

Necessity Of Ampoule Leak Test

1. Product Safety and Patient Health

The primary purpose of ampoule leak testing is to ensure the safety of the contents, especially in pharmaceutical and biomedical applications. Any leakage can allow contaminants such as bacteria, moisture, or air to enter the ampoule, compromising the sterility and effectiveness of the product. This is particularly critical for injectable drugs, vaccines, or biological solutions, where contamination can result in severe health risks for patients, including infections or allergic reactions.

2. Quality Control and Process Integrity

Leak testing is an essential part of the quality control process in ampoule production. It ensures that each unit meets the strict integrity standards before reaching the market. Consistent implementation of leak tests helps manufacturers maintain uniform product quality across batches, detect process issues early, and validate sealing equipment performance. This contributes to a reliable production workflow and minimizes variations in final product quality.

3. Regulatory Compliance and Industry Standards

Regulatory agencies such as the FDA, EMA, and organizations enforcing GMP (Good Manufacturing Practice) guidelines mandate that all sterile containers, including ampoules, must be free of leaks. Failing to comply with these regulations can result in product recalls, warning letters, or even manufacturing shutdowns. Leak testing provides documented evidence that ampoules meet container closure integrity (CCI) requirements, which is a critical element in regulatory audits and product approvals.

Cell Instruments Advantages

Professional manufacturer background

With many years of R&D and production experience, we focus on packaging, medicine, food, and electronics. We have a strong R&D team and modern manufacturing system to ensure leading product quality and technical level.

Strong custom development capabilities

With deep technical accumulation, we provide tailor-made solutions, including function adjustment, software customization, and automation transformation, to flexibly respond to various testing needs and improve testing efficiency.

Complete after-sales service system

With a technical support and after-sales service network covering the national and overseas markets, we provide full-service services such as operation training and remote diagnosis to ensure that customers are worry-free and minimize downtime.

Ampoule Leak Test