Single-use equipment in biopharma manufacturing


Sartocheck 4 plus bag tester allows reliable pre-use testing of single-use bioreactors after installation

Sartorius Stedim Biotech (SSB), an international equipment supplier to the pharma and biotech industries, has added the Sartocheck 4 plus bag tester to its Sartocheck line.

The firm says this is the first device to allow reliable pre-use testing of single-use bioreactors after installation, based on pressure decay measurement.

The Sartocheck 4 plus bag tester is designed for cell cultivation, and single-use Biostat CultiBag STR bioreactors with working volumes of 50L and 200L can now be conveniently tested by the system. Later this year, the newly developed technology of this device will be extended to permit testing of 500L and 1,000L Biostat CultiBag systems.

The Sartocheck 4 plus bag tester performs a pre-use test of the entire bioreactor, including tubing. The device is capable of detecting leaks that might have been caused by operator handling errors on installation of a bioreactor. The bag tester can therefore eliminate the risk of filling a defective single-use bioreactor with expensive cell cultures. It can do this because of its patented fleece, which is inserted between the plastic film of the Biostat CultiBag STR and the bag holding device of the tester. This fleece acts as a porous spacer, preventing direct contact between the bag and the smooth stainless steel surface of the holder. In addition, the fleece substantially reduces environmental heat transfer and, most important, eliminates the effects of masking any potential pinholes.

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According to SSB, the high accuracy of the Sartocheck 4 plus bag tester in measuring the pressure drop, along with its patented fleece technology, provides unrivalled reliability and reproducibility for testing.