Test-O-Pac expands its Medical Device Package Testing field!

Accurate and Reliable Data for Burst Testing, Creep Testing and Leak Integrity Testing

Test-O-Pac keeps growing and as a result we are investing in a new state of the art equipment to meet our client's requirements and expectation.

We have acquired BT Inegra-Pack© Package Tester to be able to cover all of the stages of Medical Device Package Testing including: Environmental Conditioning (ASTM D4332), Accelerated Aging (ASTM F1980), Package Performance Testing (ASTM D4169) and Package Integrity: Gross Leak Test (ASTM F2096), Dye Penetration Testing (ASTM F1929), Tensile/Seal Strength "Peel Test" (ASTM F88), Burst Testing (F1140) and Pressure Decay Testing (ASTM F2095).

Burst Testing San Jose

Instrument Overview

The TME BT Integra-Pack is a bench-top, high-resolution test instrument with a small footprint and user-friendly ease of operation. The instrument performs four pneumatic tests on packaging: Burst, Creep, and Creep-to-Failure (for porous or non-porous packages), and Pressure Decay Leak (for non-porous packages). Electronic pressure and flow control provide precise and repeatable test conditions, while automatic and high flow output allow testing of large porous packages. Application cover a range of flexible or rigid, porous and non-porous, open or sealed packages. Its objective is to enable you to produce a package that is as valid as the product enclosed.

 

ASTM F1140 Testing

Extensions - TS01 Open Package Fixture (ASTM F1140)

Open package test fixture is designe ot operate with the BT Integra-Pack tester. The fixture is used to clamp three sided flexible bags or pouches and provide a sealed assembly for Burst or Creep testing.

ASTM F1140 - "Standard Test Methods for Internal Pressurization Failure of Unrestrained Packages" consists of three Test Methods:

Test Method A (Burst Test)

Packages are tested in an apparatus that internally pressurizes the package until the package fails. The pneumatic supply and pressurization equipment need the capability to maintain an increasing pressure until the package bursts. The test measure is the maximum pressure detected before the package fail.

Test Method B1 (Creep Test)

Packages are tested in apparatus that internally pressurizes the package to a specified pressure and maintains that internal package pressure for a specific time. The test measure is pass/fail.

Test Method B2 (Creep to Failure)

Packages are creep-tested and held until the package fails. Test setup is similar to that of the Creep Test except the pressure setting will need to be higher to ensure the package fails in a reasonable amount of time (that is, about 15s). The test measure is the time until failure.

 

Medical Device Package Testing - Test-O-Pac Industries, Inc. San Jose,CA

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