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On 8 March 2012, the TGA announced that CSL Biotherapies had advised that some batches of its human albumin product (ALBUMEX) had been contaminated with ethylene glycol. As a public health measure, TGA quarantined all batches of the product pending further analysis.
To expedite re-supply of ALBUMEX for essential health care requirements, the TGA is allowing CSL Biotherapies to release batches of the product from quarantine where TGA is satisfied that testing of those batches has been undertaken to an appropriate standard, and that this testing demonstrates that the batch does not contain harmful levels of ethylene glycol.
About the quarantine release process
The quarantine release process requires CSL Biotherapies to arrange testing of each batch according to protocols agreed by TGA, and provide the results to the TGA for assessment. The tests being undertaken are sufficiently sensitive to detect ethylene glycol at or above 0.5 parts per million (ppm), which is well below the internationally accepted safety limit for this compound.
TGA will audit the manufacturing process at CSL Biotherapies and will independently test some batches of ALBUMEX as a quality assurance measure. This testing by TGA will not delay release of ALBUMEX batches for essential health care requirements. Release of specified batches has now commenced.