|
|
|
MedDevice-Catalog Endotoxin (LAL) |
Bacterial Endotoxin Testing (BET) | ALSO CALLED: Limulus Amebocyte Lysate (LAL) Testing Pyrogens are fever-producing materials that most often originate from gram-negative bacterial cell walls, but can also originate as leachates from some chemicals and materials. Pyrogens from bacterial cell walls (the most commonly encountered type of pyrogen) are referred to as bacterial endotoxin and are readily detected by gel clot and kinetic chromogenic Limulus Amebocyte Lysate (LAL) testing systems. Chemical pyrogens, also called materials-mediated pyrogens, can only be detected using the USP Rabbit Pyrogen Test or Materials Mediated Test. [See Page B-18.] LAL gel clot testing is a semi-quantitative method that is well suited for lot release testing of most medical device products. The kinetic chromogenic LAL method provides direct quantification of the detected endotoxin level and is especially useful for very low level detection, determining the endotoxin reduction of various production processes, monitoring the quality of water systems, and for use with samples that cannot be tested with the gel clot method. AppTec follows the FDA, USP and AAMI guidelines when performing LAL tests. Each time a new device is produced, or a significant change in material formulation is made on an existing device, a validation must be performed on samples from three production lots. The purpose of this is to ensure that the materials used in the construction of the device do not impart an inhibiting or enhancing effect on the LAL test system. Sample requirements for both the validation testing and routine testing are typically determined by the size of the production lots from which the samples are selected. In this section Gel Clot LAL Limit Test – Finished Product Testing
Gel Clot LAL Test Validation
Gel Clot LAL Liquid Test
Gel Clot LAL Dilution Assay
Kinetic Chromogenic LAL Limit Test – Finished Product Testing
Kinetic Chromogenic LAL Test Validation
Kinetic Chromogenic LAL Liquid Test
| | Gel Clot LAL Tests Back to Top | Bacterial endotoxins are the most common type of pyrogenic (fever-inducing) substance, and these endotoxins are readily detected by Limulus Amebocyte Lysate (LAL) test systems. LAL testing can be performed by either the gel-clot method (semi-quantitative) or the kinetic chromogenic method (quantitative). A validation must be performed for each product type tested to ensure there is no interference between the test system and the product materials. All LAL testing is performed according to specified USP, FDA, and AAMI standards.
| 131100 | Semi-quantitative determination of pass/fail endotoxin limit for finished devices or other materials. SAMPLE REQUIREMENTS
For lots of less than 30 units – 2 sample devices
For lots of 30-100 units – 3 sample devices
For lots of greater than 100 units – 3% of lot, up to maximum of 10
[Samples should be sterile.] Specify endotoxin limit at which you would like product tested. | Gel Clot LAL Limit Test-
Finished Product Testing |
|
| 130200 | Sample extractant is "spiked" with endotoxin and run in a quadruplicate dilution series parallel with the standard endotoxin curve. Results are evaluated for an enhancing or inhibiting effect. SAMPLE REQUIREMENTS
FDA requires that samples from three (3) production lots be evaluated for inhibition and enhancement before this test is considered validated for use with the test product. Specify endotoxin limit at which you would like product tested. | | Gel Clot LAL Test Validation |
|
| 130400 | Endotoxin testing of water system samples or other liquids. SAMPLE REQUIREMENTS
15 ml in sealed endotoxin-free polystyrene or glass container. Specify endotoxin limit at which you would like product tested. | | Gel Clot LAL Liquid Test |
|
| 130300 | Determination of a semi-quantitative endotoxin value per product weight or volume. SAMPLE REQUIREMENTS
Positive LAL sample | | Gel Clot LAL Dilution Assay |
| | f | | Kinetic Chromogenic LAL Tests Back to Top |
| 130501 | Quantitative determination of endotoxin limit for finished devices or other materials. SAMPLE REQUIREMENTS
For lots of less than 30 units – 2 sample devices
For lots of 30-100 units – 3 sample devices
For lots of greater than 100 units – 3% of lot, up to maximum of 10
[Samples should be sterile.] | Kinetic Chromogenic
LAL Limit Test-
Finished Product Testing |
|
| 130601 | Quantitative determination of endotoxin limit for finished devices or other materials. SAMPLE REQUIREMENTS
FDA requires samples from three (3) production lots be tested for inhibition and enhancement before this test is considered validated for use with the test product. | Kinetic Chromogenic
LAL Test Validation |
|
| 130701 | Endotoxin testing of water system samples or other liquids. SAMPLE REQUIREMENTS
5 ml in sealed endotoxin-free polystyrene or glass container. | Kinetic Chromogenic
LAL Liquid Test |
| Back to Top |
|
|