A leak is a material flow from or into a product in excess of allowable limits. Leak from flexible biocontainers can cause contamination of the products in the bag and also pose risk to operator safety as well as general environment. Contaimination is considered as a serious risk and often results in disposal of very valuable products, such as cell culture resuspension, bioreactor materials, final formulation, and final fill materials. In order to qualify and eliminate leaks from biocontainers and preserve product sterility, a non-destructive method has to be used prior to flexible biocontainer usages. There are several integrity tester available in today’s market with various technologies, including pressure decay, vacuum decay, flow rate, mass flow, and helium integrity testing. They are also different in sensitivity, testing bag sizes and shapes, accessories, and operation interfaces.
inSITE™ True Point-of-Use Inflation & Integrity Test System is a point-of-use integrity testing system that allows users in a biopharmaceutical manufacturing environment to confirm the integrity of single-use BPCs inside the tank that is about to be filled. inSITE™ system has the ability to find flaws on any type of bag. The inSITE functions to inflate single-use bags after they have been installed and then monitors the bag looking for a decay in pressure that would indicate a leak. View video ›
Palltronic® Flowstar LGR Test Instrument enables point-of-use leak testing of single-use systems up to 200 L nominal volume and also provides the ability to test the integrity of the filters within the single-use systems (Product Brochure). This technology is based on flow measurement, it has small footprint, easy to use, and suitable for both pre and post-use integrity tests of filters and integrated single-use systems. The instrument allows end users to test endless configurations of single-use systems and filters without compromising the sterility of the system.
ATC leak testing products, based on ATC patented Micro-Flow Technology with optional accessories, are designed for testing containers under pressure or vacuum. Mass Extraction technology are based on Mass Extraction and Micro-Flow Technology, the products use air and offer an alternative to Helium and other tracer gas leak testing methods. Pressure Based Model are also based on patented Micro-Flow Technology and are designed for testing under pressure. ATC also work closely with customers throughout the process of designing and building Custom Leak Test Machine to meet unique operational requirements.
Nikka Densok USA (part of Nikka Densok LTD), specializes in integrity testing using High Voltage Leak Detection (HVLD). Nikka Densok Pinhole Inspectors are designed for non-destructive testing of a wide variety of packages including glass, plastic and flexible packaging that contain an electrically conductive solution. Nikka Densok Pinhole Inspectors products are available for IV Bag Inspection, Small Volume Bottle Inspection, Large Volume Bottle Inspection, and Vial Inspection.
Cincinnati Test Systems (CTS) designs and manufactures leak test systems, leak detection equipment, gas charge and reclaim handling equipment, and related components and accessories. Testing solutions include Function Test Systems, Tracer Gas Leak Test Systems, Mass Flow Test Systems, Pressure Decay Test Systems, Pressure Gain Systems, Pressure Testing, and Vacuum Leak Test Systems. CTS also offer a variety of Leak Test Accessories to compliment for air leakage testing equipment such as high and low pressure gauges, leak finder pro, tracer gas leak standards, Gas Handling Equipment, seals, luer connectors, and more.
FlexAct® BT is a Bag Tester solution based on Pressure Decay Method at the point of use. FlexAct® BT features the Sartocheck® 4 Plus bag tester and a set of two plate holders to perform pressure decay testing. Datasheet: Sartocheck® 4 Plus Filter Integrity Tester
Wilco leak detection methods and instruments include LFC “Liquid Filled Container” that meaures the loss of vacuum inside a test chamber as a result of gas leakage or liquid vaporization from a leak; Laser based Headspace Analysis, HSA is non-destructive measurement of oxygen concentration/partial pressure, or carbon dioxide concentration/partial pressure, or total pressure conditions inside a container (mainly parenteral packaging); Infrared Laser, AE/GD is Laser based, non-contact leak testing of filled aerosol cans. Pressure decay combined with high pressure test, AE is leak testing technologies for empty steel or aluminum aerosol cans; Vacuum and pressure decay, PV is for detecting leaks in empty containers; Force Sensor technology, FS is a non-destructive system for flexible packages like blister, IV bags or induction sealed bottles. This technology is applied combining mechanical forces, squeezing, or vacuum forces, generated with a vacuum pump.
- Integrity Testing of Flexible Containers
- Integrity Testing of Flexible 2D/3D Bags and Manifolds Using Helium Integrity Testing Platform (HIT™)
- Pharmaceutical container/closure integrity. V: An evaluation of the WILCO “LFC” method for leak testing pharmaceutical glass-stoppered vials
- Closure Integrity Testing for Pharmaceutical Containers & Products
- Advanced Leak Test Methods
- Micro-Flow vs. Helium Mass Spectrometry (Chamber Test)
- Mass Extraction for sterile product CCIT
- Laser Based Headspace Analysis
- Pressure Decay Method for Postinstallation Single-Use Bioreactor Bag Testing
- Single-Use Integrity Testing Goes Mobile
- Helium Integrity Testing of Single-Use Vessels
- FlexAct BT for Integrity Testing of Single-Use Bags
- Preuse, Poststerilization Filter Integrity Testing for Single-Use and Stainless-Steel Installations
- Ensuring Integrity and Sterility of Single-Use Assemblies
- Pressure Rating for Bioprocess Single-Use Assemblies
- Point-of-Use Disposable Bag Testing
- Single-Use Connections Enable Advancements in Aseptic Processing