PTS™/MCS™ Cartridge Compliance

Licensed by the US FDA in 2006, our pre-calibrated, single-use disposable LAL test cartridge utilizes traditional chromogenic LAL reagent and substrate. The cartridge is used in conjunction with a CE certified portable or multi-cartridge spectrophotometer for end product release testing. The cartridge contains four channels - two channels with CSE and LAL, which serve as the positive control channels, and two channels with LAL for testing of samples. The cartridge is designed to allow duplicate test results, consistent with current U.S. Pharmacopeia bacterial endotoxin test (BET) photometric techniques (Method D chromogenic kinetic) for quantitative limulus amebocyte lysate (LAL) methods.

The LAL test cartridge technology has been approved and licensed by the US FDA for final product, in-process and raw material testing, under the compendia BET Chapter requirements for the Method D chromogenic kinetic technique, a fact that was reiterated recently in a presentation given at the Bacterial Endotoxin Summit by Dr. Robert J. Mello, FDA Senior Review Microbiologist. Furthermore, the British Pharmacopoeia Commission (BP) and the European Directorate for the Quality of Medicines and HealthCare (EDQM) both confirmed that our LAL test cartridge uses traditional chromogenic LAL reagent and is sufficiently covered by the text of the current harmonized test. No further elaboration to the text was considered necessary unless further developments were to place a demonstrably suitable technique outside the scope of the current described test. Therefore, experts in the field understand and agree that this test is nothing more than a kinetic chromogenic LAL assay, covered under the Photometric Methods section in the Harmonized BET.

Technical Documents

Endosafe®-PTS™ and Regulatory Requirements: USP BET<85> or EP BET<2.6.14>

This technical sheet provides an overview of USP/EP requirements for the Endosafe®-PTS™.

Endosafe®-PTS™ and Regulatory Requirements: FDA Guidelines

The Endosafe®-PTS™ technology was not available when the 1987 and 1991 FDA Guidelines Interim Guidance documents were written. These guidelines stated that archived standard curve requirements apply to LAL test systems that a) require daily preparations of PPC, which is a significant source of variability in the LAL laboratory, and b) require reconstituted multi-test LAL reagent.

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