Lyophilizer Leak Testing

HVS Leak Detection provides leak testing of vacuum freeze drying equipment and lyophilizers used in the pharmaceutical and biotech industry. We helium leak test pharmaceutical plant and biotech laboratory equipment and systems including: production lyophilizers, pilot lyophilizers, and light production freeze dryers.

Helium Leak Testing Lyophilizers

Pharmaceutical freeze dryers and lyophilizers should be leak tested to maintain the integrity of their vacuum systems and refrigeration systems as well as any freeze drying sub-systems such as process vessels, chambers, condensers, vacuum isolation valves, vacuum lines & vacuum seals.

Our technicians helium leak test lyophilizers to check for gross leaks in the freeze dryer vessel itself, which can prevent the vessel from reaching the pressure necessary for proper operations.

The primary and secondary drying phases of the lyophilization cycle must take place in a vacuum. The lyophilization process occurs in an evacuated vessel which must maintain the sterility of the product in the vacuum. We can helium leak test lyophilizers to measure the tightness of the system and detect and measure any inleakage that might affect product sterility.

We helium leak test lyophilizers for small leaks that allow the system to operate but reduce its efficiency. These leaks can be due to flaws in the vacuum lines, gas supply, compressors, condensers, valves.

Lyophilizer & Freeze Dryer Maintenance

• Leak Test Vacuum System
• Leak Test Vacuum Line
• Leak Test Vacuum Pump
• Leak Test Vacuum Seals
• Leak Test Refrigeration System
• Leak Test Condenser
• Leak Test Compressor
• Leak Test Regulating Valves

Common points for In-leakage

• Door Seals
• Main Vapor Valve Flanges
• Instrumentation Connections
• Thermocouple Feedthroughs
• Relief Valves
• Process Valves

Real Leaks and Virtual Leaks in Lyophilizers

When performing vacuum integrity tests, it is necessary to distinguish between real leaks and virtual leaks. Virtual leaks are not actual leaks caused by a breach in the vessel or seals. Gas pockets, humidity or fluids contained in the vessel can create the appearance of a defect in the physical structure of the vessel. It is important to eliminate virtual leaks when leak testing lyophilizers and freeze dryers.