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inSITE Integrity Testing System

Although BioProcess Containers (BPCs) undergo testing at the manufacturer’s facility, improper handling and loading procedures could introduce flaws to the BPC system. Using sterile air, the inSITE Integrity Testing System is able to find gross and fine flaws at the most critical stage—immediately prior to filling.

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 inside the tank that is about to be filled.

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Advantages of the inSITE Integrity Testing System

The inSITE Integrity Testing System involves:

  • Point-of-use integrity testing: BPCs are tested in the tank that is to be filled.
  • Guided validation setup suitable for containers up to 5,000 L.

Advantages of the system include:

  • Able to detect gross and fine leaks for quick and efficient confirmation of integrity.
  • Inflation procedure helps improve loading and placement within the tank.
  • When the BPC is ready to be filled with product, the liquid filling cycle moderates the internal pressure within the BPC as fluid is introduced.

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

  1. 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.
  2. 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.
  3. 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.
  4. 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.

The inSITE Integrity Testing System involves:

  • Point-of-use integrity testing: BPCs are tested in the tank that is to be filled.
  • Guided validation setup suitable for containers up to 5,000 L.

Advantages of the system include:

  • Able to detect gross and fine leaks for quick and efficient confirmation of integrity.
  • Inflation procedure helps improve loading and placement within the tank.
  • When the BPC is ready to be filled with product, the liquid filling cycle moderates the internal pressure within the BPC as fluid is introduced.

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

  1. 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.
  2. 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.
  3. 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.
  4. 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.

inSITE Integrity Testing System Overview Video

See how the inSITE system operates and provides the confidence of a final integrity test prior to use, at the point-of-use.

Related products

Available in standard or custom configurations, covering a range of applications, sizes, and connection systems.

Outer support containers are designed for storage, collection, harvest and other processes.

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