Endotoxin Indicators Vials

The Endotoxin Indicator Vials are ready-to-use vials composed of E. coli O55:B5 (>1000 EU/vial) for performing depyrogenation validation studies to ensure that a process is effectively inactivating and/or destroying endotoxin. These vials may be tested using reagents from our PYROSTAR™ ES-F series.

Key Features

  • E. coli 055:B5 (> 1000 EU/vial)
  • Ready to use vials, no preparation needed
  • Used for dry heat oven validation studies
Catalog Number Contents
EIV-025 25 vials (>1000 EU/vial)

FAQ: Endotoxin Indicators Vials

Q: Can the Endotoxin Indicator Vials withstand a temperature greater than 250°C?

A: The Endotoxin Indicators Vials were designed to withstand 250°C for 30 minutes.

Q: How is the three-log reduction for gel clot assays calculated?

A: Calculation of the minimum three-log reduction is as follows:

Log Reduction = log (endotoxin potency unbaked vial) – log (endotoxin potency baked vial)

Example: This example calculation is performed by using a LAL sensitivity 0.25 EU/mL, an Endpoint Dilution Factor of 1:10,000 for the unbaked control vial, and a negative reaction for the baked vial.

Note: The dilution factor for undiluted samples is 1.

Original endotoxin potency of the unbaked vial:

Endotoxin Potency (EU/vial): 0.25 EU/mL x 1 mL/vial x 10,000 = 2,500 EU/vial

The negative reaction in the baked vials indicates a final endotoxin potency:

Endotoxin Potency (EU/vial): <0.25 EU/mL x 1 mL/vial x 1= <0.25 EU/vial

Calculation of the minimum log reduction:

Log Reduction: log 2,500 EU/vial – log 0.25 EU/vial = 4

Q: How is the three-log reduction for kinetic assays calculated?

A: Calculation of the minimum three-log reduction:

Log Reduction = log (endotoxin potency unbaked vial) – log (endotoxin potency baked vial)

Example: The software determined that the endotoxin concentration of the unbaked vial was 4,200 EU/mL and endotoxin concentration of the baked vial was 0.20 EU/mL.

Original endotoxin potency of the unbaked vial:

Endotoxin Potency (EU/vial) = 4,200 EU/mL x 1 mL/vial = 4,200 EU/vial                                                      

The endotoxin potency of the baked vial:

Endotoxin Potency (EU/vial) = 0.20 EU/mL x 1 mL/vial = 0.20 EU/vial

Calculation of the minimum log reduction:

Log Reduction: log 4,200 EU/vial – log 0.20 EU/vial= 4.322