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Integrity Testing
inSITE Integrity Testing System
Although BioProcess Containers (BPCs) undergo quality testing at the manufacturer’s facility, improper handling and loading procedures can introduce flaws during shipping, storage, and unpacking.
The inSITE Integrity Testing System is a true point-of-use integrity testing system that allows users in a biopharmaceutical manufacturing environment to confirm the integrity of single-use BPCs. Using sterile air, the inSITE system can help detect gross and fine flaws at a very critical time—immediately prior to BPC filling. Multi-channel features enables conduct testing on multiple BPCs simultaneously—additionally, manifolds and assemblies can be tested. Regardless of geographical location, the inSITE system can be utilized without concern of region-specific electrical requirements.
Advantages of the inSITE Integrity Testing System
System features include:
- Single- and multi-channel, point-of-use integrity testing
- Universal electrical requirements eliminate concerns of region-specific power sources
- On-board blower makes the system completely mobile
- Built-in printer is used to print all test result labels
System capabilities include:
- Guided validation setup
- Tests BPCs up to 5,000 L
- Gross and fine leak detection
- Inflation procedure improves loading and placement in tanks
- Liquid filling cycle regulates internal pressure while fluid is being introduced
- Uninterrupted power supply provides 10-15 minutes of power to operate the computer system should there be a main power outage
Extend the level of quality assurance that Thermo Fisher Scientific offers to the end user
Although stringent standards—such as raw material inspections, in-process pressure decay testing, sealing validations, and packaging and shipping procedures—are maintained for all products, there is potential for damage after the product leaves the facility, specifically during BPC handling and placement. At the critical stage of fluid filling, the inSITE system offers a level of confidence to biopharmaceutical manufacturers by helping to ensure that their product will enter a viable BPC.
Four distinct phases to pressure decay testing
Inflation cycle:
Inflation is the period of time in which the BPC is being pressurized to a predetermined test pressure through an onboard blower. The air is forced through a 0.2 micron (μm) sterilizing-grade filter.Charge time:
During the charge time phase, the BPC stretches, allowing any creases that may be present to unfold. If necessary, the blower will add air to maintain the initial predetermined test pressure.Settle time:
The settle phase is the time allowed for the volume of the BPC to change and stabilize due to stresses introduced by pressurization. The adiabatic temperature also stabilizes during the settle phase.Test time:
The test time is the period during which the decay of pressure is measured and recorded. This decay in pressure will distinguish between a flawed and nonflawed BPC.
System features include:
- Single- and multi-channel, point-of-use integrity testing
- Universal electrical requirements eliminate concerns of region-specific power sources
- On-board blower makes the system completely mobile
- Built-in printer is used to print all test result labels
System capabilities include:
- Guided validation setup
- Tests BPCs up to 5,000 L
- Gross and fine leak detection
- Inflation procedure improves loading and placement in tanks
- Liquid filling cycle regulates internal pressure while fluid is being introduced
- Uninterrupted power supply provides 10-15 minutes of power to operate the computer system should there be a main power outage
Extend the level of quality assurance that Thermo Fisher Scientific offers to the end user
Although stringent standards—such as raw material inspections, in-process pressure decay testing, sealing validations, and packaging and shipping procedures—are maintained for all products, there is potential for damage after the product leaves the facility, specifically during BPC handling and placement. At the critical stage of fluid filling, the inSITE system offers a level of confidence to biopharmaceutical manufacturers by helping to ensure that their product will enter a viable BPC.
Four distinct phases to pressure decay testing
Inflation cycle:
Inflation is the period of time in which the BPC is being pressurized to a predetermined test pressure through an onboard blower. The air is forced through a 0.2 micron (μm) sterilizing-grade filter.Charge time:
During the charge time phase, the BPC stretches, allowing any creases that may be present to unfold. If necessary, the blower will add air to maintain the initial predetermined test pressure.Settle time:
The settle phase is the time allowed for the volume of the BPC to change and stabilize due to stresses introduced by pressurization. The adiabatic temperature also stabilizes during the settle phase.Test time:
The test time is the period during which the decay of pressure is measured and recorded. This decay in pressure will distinguish between a flawed and nonflawed BPC.
Related products
Available in standard or custom configurations, covering a range of applications, sizes, and connection systems.
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