#Product Trends
ASTM F2338 Leak Testing for Pharmaceutical Vials and Bottles with the TSC 500
Non-destructive vacuum decay leak detection for small pharmaceutical containers with repeatable testing, traceability, and faster batch inspection
In pharmaceutical packaging, identifying leaks in small containers such as vials and bottles remains a major quality concern. The inspection method must be sensitive enough to reveal defects that could affect package integrity, while also avoiding product destruction, production delays, and unnecessary waste.
For this type of requirement, ASTM F2338 is an important reference for non-destructive leak detection based on the vacuum decay method. To show this method in a practical context, we use the TSC 500, a solution developed for non-destructive testing of small pharmaceutical containers in applications aligned with ASTM F2338.
How the TSC 500 Performs the Test
The TSC 500 detects leaks through vacuum decay or pressure decay, using differential measurement with sensitivity at the pascal level. Its test sequence follows a controlled cycle:
- Vacuum generation
- Stabilization
- Test
- Verification
- Return to atmospheric pressure
This sequence is intended to provide reliable, repeatable measurements and to support a more standardized testing routine.
The equipment includes an integrated vacuum pump with electronic regulation down to -700 mbar. Its reduced internal volume contributes to faster test cycles and improved measurement sensitivity, which is especially relevant when testing small containers. Its integrated sealing system and drawer-style closing mechanism also support easier day-to-day operation.
Built for Pharmaceutical Industrial Environments. The TSC 500 is intended for industrial pharmaceutical use and includes:
- 5-inch color touchscreen
- 64 test programs
- USB data export
- RJ45 connectivity
- Optional serial printer
- Integrated vacuum pump
- Electronic vacuum regulation
- Audit Trail functionality
For pharmaceutical quality teams, traceability is an essential part of the testing process. The Audit Trail function helps reinforce data integrity by supporting controlled records of system activity, test execution, and process history.
Increasing Efficiency in Batch Inspection
The goal today is not only to improve how testing is performed. It is also to improve how efficiently it can be carried out.
Consider a situation where more than 100 bottles must be inspected before releasing a production batch. In that context, reducing inspection time becomes highly important. Because the TSC 500 can test up to four products simultaneously, it can help reduce the time needed to inspect a full sample batch while maintaining the sensitivity and reliability required in pharmaceutical quality control.
Depending on the application and test setup, the TSC 500 may help achieve time savings of up to 50%, supporting more efficient operator workflow and faster quality decisions.
Support from DVACI
At DVACI, we support each project by helping define the most appropriate approach for the application. This support may include needs assessment, configuration selection, equipment installation, and validation support for the specific product and testing process.
Every pharmaceutical container behaves differently. Container size, rigidity, closure system, product characteristics, and the expected type of defect can all influence both the test method and the final parameters. For that reason, selecting the right configuration is as important as selecting the right standard.
Evaluate This Method with Your Own Products
Would you like to assess this method on your own vials, bottles, or pharmaceutical containers?
Contact DVACI to discuss your testing requirements, product characteristics, and the configuration most suitable for your application. Our technical team can help you improve your pharmaceutical leak testing process with a non-destructive, repeatable, and efficient solution.
