Validated Shipping Of Filled Labtainer Pro BioProcess Containers (BPCs)

Scope

Wet shipping tests are performed to ensure that Thermo Scientific™ Labtainer™ Pro BioProcess Containers (BPCs) maintain  integrity, keeping contents contained and protected. During shipping, wave action within a fluid-filled BPC exerts stress on the film, which can lead to cyclic fatigue of the materials. A variety of shipping tests were conducted on the Labtainer Pro BPC product line, including vibration testing, compression testing, and drop testing. Following the completion of this testing, all chambers were integrity-tested for leaks.

Testing

The packaging and shipping of liquid-filled Labtainer Pro BPCs were tested per International Safe Transit Association (ISTA™) 2A and 3E standards. Four packaging configurations were developed and qualified to support the range of sizes for the Labtainer Pro BPCs (Tables 2–4).

All porting configurations are included in the liter chamber testing (2-, 3-, and 4-ports). All chambers were gamma-irradiated at 40–80 kGy, and filled to nominal volume with water.

Results

All configurations were tested for both the ISTA 2A standard (individually packaged product testing) and the ISTA 3E standard (palletized testing). The Labtainer Pro BPCs passed 13 different tests as detailed in Tables 6 and 7.