Pyrogen-free LAL test consumables

The LAL test is a delicate and sensitive analysis, even to substances that can interfere with the enzymatic reaction underlying the test. For this reason it is essential to use certified pyrogenic consumables, free of endotoxins and interfering substances.

To set up the test, the following dedicated, non-pyrogenic and interfering agent-free consumables are required:

Water
Glassware
Plasticware
Buffer, acid or basic solutions

Pyrogen-free LAL Reagent Water

Pyrogen-free glassware for LAL test

Pyrogen-free plasticware for LAL test

Pyrogen-free buffers, acid or basic solutions

LAL Water (LRW)

Both LAL and CSE reagents (and also RSE and BRP) are supplied as a lyophilized powder, and must be reconstituted with water. LRW (LAL Reagent Water) is defined as the water that can be used for the LAL Test, both for the reconstitution of the reagents and for the preparation of the product during the test.

LAL water is supplied in glass bottles of various volumes and is certified with endotoxin content < 0.001 EU/ml).

Water for injection (WFI) has an endotoxin limit of 0.25 EU/ml and cannot therefore be used to prepare the LAL test.

Non-pyrogenic glassware

Tubes for testing and sample preparation, pipettes for dispensing, containers of various kinds.

The preferred materials are borosilicate and soda glass, the latter only for some test tubes. The pyrogenic glassware is certified with a limit of 0.001 EU/ml and free of interfering factors.

Non-pyrogenic plasticsware

Various containers, tips, pipettes and test tubes. When choosing these materials, some parameters must be taken into consideration:

• endotoxin content: generally plastic products are certified with a maximum content of 0.005 EU/ml, although more often they are certified like medical devices, i.e. 0.5 EU/ml.

• type of plastic: polypropylene is the material that best meets the needs of the LAL test; for the other materials (polystyrene, polyethylene) interference with the test has been demonstrated, mainly due to the tendency of the endotoxin to stick to the walls and to the release of interfering substances.

Pyrogenic plasticware is certified with a limit of 0.5-0.005EU/ml and free of interfering factors.

Buffer solutions, acidic or basic

Buffers and solutions for adjusting pH and interferences.