Comparison of commercial pyrogen testing laboratories.

Abstract

The pyrogen test results of four laboratories were compared to determine if any inconsistencies existed. Samples submitted for pyrogen testing were of two types: (1) radiopharmaceuticals which had been allowed to decay to negligible activity or mock radiopharmaceuticals prepared with saline instead of pertechnetate, and (2) positive controls of bacterial endotoxin. The drugs used in the eight-rabbit tests included 99mTc-macroaggregated albumin, 99mTc-human serum albumin, 99mTc-sulfur colloid, saline and iodinated fibrinogen. Laboratory A showed a 52% failure rate for the testing of 36 preparations. Samples identical to those not passed by laboratory A were passed by laboratories B, C and D. It is recommended that all users of pyrogen testing laboratories periodically submit samples of known apyrogenicity for testing.