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Bonfiglioli Vacuum Decay Leak Detection for Pre-filled Syringes
Bonfiglioli Engineering (BE) has developed Vacuum Decay Leak Detection as an effective method of testing for leaks in pre-filled syringes, carpules and injection devices that can be integrated into different types of machines to be applied in laboratory and 100% in-line testing at various stages of the package lifecycle.
The technology allows end users to ensure efficient and productive manufacturing and packaging while also meeting safety requirements, international regulations, and market quality standards.
Vacuum Delay Leak Detection method and benefits
Vacuum Delay Leak Testing takes place in a patented airtight Testing Chamber in which a pressure differential is applied to detect container leakages by measuring attained pressure level as well as pressure change over the test period. The test will result in a Pass, Fail Gross, or Fail differential pressure (ΔP) outcome that can be displayed on the Human Machine Interface (HMI) screen. The high reliability and reproducibility of the method allows integrity of the tested container to be assessed in a few seconds.
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 repeated tests at different times to validate stability of packaging assemblies and can be applied as an in-process control (IPC) to ensure robust package container closure integrity (CCIT).
Vacuum delay leak testing technology can also be integrated and combined with Automatic Visual Inspection and Headspace Gas Analysis to support the end user in required testing processes
The Vacuum Decay testing method is based on ASTM F2338-09 for leak testing containers, which is a consensus standard recognized by the US Food & Drug Administration (FDA) and included in the list of Deterministic Leak Test Technologies in the US Pharmacopeia (USP) General Chapter <1207>.
Bonfiglioli Engineering machines have a SCADA system for full data collection and control capability. The computerized system contains the required technical elements to be compliant with EU Annex 11 and 21 CFR part 11 to meet the latest updates on regulatory requirements in terms of data integrity.
The equipment qualification and validation comply with requirements stated in EU Annex 15. The equipment manufacturing process and materials are compliant with applicable GMP requirements.
Bonfiglioli Leak Detection Solutions
Bonfiglioli Engineering provides varied leak detection solutions from lab to inline machines, for pre-filled syringes, cartridges and carpules. The machines include features like quick format changeovers, automatic drying systems for no testing chamber contamination, auto test in real time and Manufacturing Execution System (MES) for remote machine data exchange and download.
Bonfiglioli Engineering offers a range of three leak detection platforms that use the Vacuum Delay method:
- LF-S11: Compliant with requirements of 21 CFR part 11 as suitable for laboratory applications, statistical purposes, and off-line leak testing, this machine performs leak testing after the pre-filled syringe is manually loaded into the vacuum test chamber by an operator. After testing, containers are manually unloaded from the chamber and managed according to test results of the test.
- LF-SMH: suitable for laboratory applications, statistical purposes, and off-line testing, this machine also performs leak testing process after pre-filled syringes are manually loaded into its vacuum test chambers but can simultaneously test up to five syringes, offering significant time savings. While one set of Pre-filled Syringes is being tested, another set can be loaded into the chambers for fast turnaround. Following the testing process, the containers are manually unloaded and managed according to test outcomes.
- PK-SY: Suitable for 100% In-Line and off-Line testing, this machine performs leak testing in continuous operation by means of testing chambers under vacuum disposed on a rotating central carousel. After testing, containers are automatically unloaded from the testing area and sorted according to test results.
When a container is inserted into Vacuum Delay chamber, differential pressure is generated inside and outside. Once equilibrium pressure is established, a sensor monitors any change in the pressure between sequential readings to determine if gas is leaking or liquid is evaporating into the chamber. The HMI displays one of three distinct outcomes:
a) Pass: Achieving and maintaining equilibrium pressure (red line)
b)Gross Fail to achieve equilibrium pressure (blue line) indicating container with large leak
c)Fail ΔP: Initial achievement of equilibrium with fall away on second reading, indicating small leak.