Leak inspection is fundamental for the pharmaceutical industry

Vacuum Decay method for leak detection of Pre-filled syringes has proven to be an effective method of testing. In this application note, we demonstrate the benefits and its application to better understand how the technology works. The Vacuum Decay testing method is based on ASTM F2338-09* for leak testing containers which are a recognized consensus standard by the FDA and are included in the list of Deterministic Leak Test Technologies of USP General Chapter.

Tested products:

▪ Carpules,

▪ Injection Devices,

▪ Pre-filled Syringes.


Testing to prove containers integrity for proper sealing and absence of any product leak after packaging ensures pharmaceutical companies’ compliance with regulatory recommendations in the use of a deterministic test method for sterility and stability. Employing a non-destructive method allows for repeating tests also at different times, in order to validate the packaging assembly and components stability; it can also be a good business practice as an in-process control to ensure robust control of the package container closure integrity (CCIT).


The technology allows end-users to ensure efficient and productive manufacturing and packaging while also meeting safety requirements, authorities’ regulations, and market quality standards. The possibility to integrate the technology into different types of machines allows for its application to the various stages of the package lifecycle. This kind of flexibility helps the client to apply it to small scale testing as well as to 100% in-line testing.


The Leak Test takes place in an airtight Testing Chamber in which a pressure differential is applied (Patent No. 1225063 of 13-9-1988). The test objective is to detect container leakages by measuring the reached pressure level as well as the pressure change over the test period. The test will result in a Pass, Fail Gross, or Fail differential pressure (ΔP) outcome, and will be displayed on the Human Machine Interface (HMI) screen. The high reliability and reproducibility of the method allow determining in a few seconds the integrity of the tested container.


Bonfiglioli Engineering lab appliances and automatic machines have been successful in testing for critical defects in individual containers. The technology has been used and implemented for several applications with different types of Pre-filled Syringes, Carpules and Injection Devices, speed, and leak requirements. We offer excellent test capabilities for those looking for machines ranging from small manual units to 100% in-line solutions. Bonfiglioli Engineering test appliances have a long record as a proven non-destructive test method with a fast ROI compared to traditional destructive test methods such as blue dye and microbial ingress testing. Bonfiglioli Engineering solutions take advantage of electronic and pneumatic components state of the art which are a common factor between the entire range of testers for Lab, off-line and in-line applications. This allows end-users to utilize the same test method from the early stages in the lab, through clinical trials and into full-scale manufacturing with 100% inspection.

The LF-S11 SY is suitable for laboratory applications, statistical purposes, and off-line leak testing. It performs the leak testing process after the Pre-filled Syringe is manually loaded into the test chamber by an operator. Following the testing process, the containers are manually unloaded from the chamber and they are managed according to the results of the test. This equipment is fully compliant with the requirements of 21 CFR part 11.

To find out more about the Benchtop CFR21 Part 11 Compliant CCI Tester LF-S11 SY please contact our representatives.

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