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Comparison of commercial pyrogen testing laboratories
American Journal of Hospital Pharmacy
|August 1, 1976
Summary
Pyrogen testing showed significant inconsistencies between laboratories. One lab had a high failure rate, passing none of the samples that other labs deemed safe. Regular testing of known safe samples is recommended.
Area of Science:
- Nuclear medicine
- Pharmacology
- Laboratory science
Background:
- Pyrogen testing is crucial for ensuring the safety of pharmaceutical products, especially radiopharmaceuticals.
- Inconsistencies in pyrogen testing can lead to the release of unsafe products and impact patient care.
- Radiopharmaceuticals require specialized testing due to their short shelf-life and radioactive nature.
Purpose of the Study:
- To evaluate the consistency of pyrogen test results across four different laboratories.
- To identify potential discrepancies in pyrogen testing protocols and outcomes.
- To assess the reliability of pyrogen testing for radiopharmaceutical preparations.
Main Methods:
- Comparison of pyrogen test results from four laboratories using identical samples.
- Testing included radiopharmaceuticals with negligible activity and positive controls of bacterial endotoxin.
- Eight-rabbit pyrogen tests were conducted using various drugs, including 99mTc-labeled agents and saline.
Main Results:
- Laboratory A exhibited a 52% failure rate in testing 36 preparations.
- Samples that failed in Laboratory A were consistently passed by Laboratories B, C, and D.
- Significant variability in pyrogen test outcomes was observed between the participating laboratories.
Conclusions:
- There are notable inconsistencies in pyrogen testing results among different laboratories.
- Users of pyrogen testing services should verify laboratory reliability.
- Periodic submission of known apyrogenic samples is recommended to ensure testing accuracy.