Endotoxin Control
Fujifilm
“>Founded in 1981, FUJIFILM Wako Chemicals U.S.A. Corporation has become a trusted global supplier of high-purity chemicals and reagents, currently operating from its headquarters in Richmond, Virginia. In 2012, they introduced the PYROSTAR™ ES-F series, a precise and reliable solution for bacterial endotoxin detection. This LAL reagent, along with a range of complementary products, offers a complete solution for endotoxin testing. Recognized for its commitment to quality and customer service, FUJIFILM Wako’s dedicated team strives to help laboratories maintain the highest standards in quality control.
LAL Techniques
GEL CLOT
Gel-clot assays operate on both a qualitative and semi-quantitative basis. Gel-clot assays are subjected to incubation at 37°C ± 1°C for 60 ± 2 minutes using a water bath, dry block incubator, or tube reader. Following the incubation period, the tube is carefully inverted 180° to assess the formation of a firm gel at the bottom of the tube. If the gel structure within the tube remains undisturbed and retains its integrity, the result is considered positive. If the gel disrupts or collapses, the result is considered negative.
TURBIDIMETRIC
Turbidimetric assays utilize changes in turbidity to assess the presence of endotoxins. The end-point turbidimetric reaction is quantified after a defined period following the combination of the reagent and the sample. The kinetic-turbidimetric reaction determines the time required to achieve a pre-established optical density or threshold value. Both methodologies can be measured at approximately 405 nm under incubation at 37°C ± 1°C using a microplate or tube reader and are capable of generating a linear regression of the standards.
CHROMOGENIC
Turbidimetric assays utilize changes in turbidity to assess the presence of endotoxins. The end-point turbidimetric reaction is quantified after a defined period following the combination of the reagent and the sample. The kinetic-turbidimetric reaction determines the time required to achieve a pre-established optical density or threshold value. Both methodologies can be measured at approximately 405 nm under incubation at 37°C ± 1°C using a microplate or tube reader and are capable of generating a linear regression of the standards.
FUJIFILM Wako provides a new line of reagents formulated to perform each of the three endotoxin detection assays: the Gel-Clot assay, the Kinetic Turbidimetric assay (KTA), 1 and the Kinetic Chromogenic assay (KCA). Traditional LAL reagents are untreated, 2 meaning they react not only with endotoxins but also with (1,3)-β-D-glucan, a component of fungal cell walls that initiates the coagulation cascade by activating the Factor G pathway (see page 6). (1,3)-β-D-glucan activation will generate a false positive endotoxin result because it is difficult to determine which pathogen is being measured.
LAL activation by (1,3)-β-D-glucan in a sample can be avoided by adding a high amount of carboxymethyl curdlan (CMC), which does not interfere with endotoxin quantification. FUJIFILM Wako first utilized these findings when developing an endotoxin-specific buffer containing high concentrations of CMC. Each reagent also contains buffering components that help maintain most assay mixtures within the pH range necessary for accurate and reliable results (6.0–8.0).
Available only in Fujifilm authorized countries.
PYROSTAR™ | ES-F SERIES
The PYROSTAR™ ES-F series of reagents is specific for endotoxins and is specifically formulated not to react with (1,3)-β-D-glucan. Furthermore, these products serve a dual purpose, meaning they are formulated for use in either the Gel-Clot or Kinetic Turbidimetric assay. They are available in single-test or multi-test configurations.
These reagents require only one Certificate of Analysis (CoA), regardless of whether they are used for the Gel-Clot or Kinetic Turbidimetric assay. PYROSTAR™ ES-F/Plate requires a separate CoA. All reagent kits are matched with specific Control Standard Endotoxins (CSE). These reagents perform well with colored samples or samples that present quantification difficulties with KCA.
PYROSTAR™ ES-F SINGLE TEST
The single-test vials come with LAL reagent already dispensed for a single measurement. This configuration is used by adding 0.2 mL of the sample directly to the reaction vial with the lyophilized reagent. The test vial is designed for use with our Toxinometer® measurement system to assist laboratories in the transition from the gel-clot method to the Kinetic Turbidimetric method. The single-test configuration is ideal for testing a small number of samples or for a less experienced user.
| Catalog Number | Gel Clot Sensitivity (EU/mL) | Kinetic Turbidimetric Quantitative Range (EU/mL) |
|---|---|---|
| WPESK-0015 | 0.015 | 0.001 to 10 |
| WPESK-0003 | 0.03 | 0.01 to 10 |
| WPESK-0125 | 0.125 | 0.01 to 10 |
| WPESK-0025 | 0.25 | 0.01 to 10 |
PYROSTAR™ ES-F MULTI-TEST
This multi-test vial is designed for use with a water bath, heat block, or Toxinometer®. With this configuration, the user dispenses 0.1 mL of reconstituted LAL reagent into the appropriate reaction tube and adds 0.1 mL of sample. This multi-test vial is ideal for users performing assays on a large number of samples.
| Catalog Number | Gel Clot Sensitivity (EU/mL) | Kinetic Turbidimetric Quantitative Range (EU/mL) |
|---|---|---|
| WPEK4-20015 | 0.015 | 0.001 to 10 |
| WPEK4-20003 | 0.03 | 0.01 to 10 |
| WPEK4-20006 | 0.06 | 0.01 to 10 |
| WPEK4-20125 | 0.125 | 0.01 to 10 |
| WPEK4-20025 | 0.25 | 0.01 to 10 |
| Catalog Number | Gel Clot Sensitivity (EU/mL) | Kinetic Turbidimetric Quantitative Range (EU/mL) |
|---|---|---|
| WPEK4-50015 | 0.015 | 0.001 to 10 |
| WPEK4-50003 | 0.03 | 0.01 to 10 |
| WPEK4-50006 | 0.06 | 0.01 to 10 |
| WPEK4-50125 | 0.125 | 0.01 to 10 |
| WPEK4-50025 | 0.25 | 0.01 to 10 |
| Catalog Number | Gel Clot Sensitivity (EU/mL) | Kinetic Turbidimetric Quantitative Range (EU/mL) |
|---|---|---|
| WPEM-20015 | 0.015 | 0.001 to 10 |
| WPEM-20003 | 0.03 | 0.01 to 10 |
| WPEM-20006 | 0.06 | 0.01 to 10 |
| WPEM-20125 | 0.125 | 0.01 to 10 |
| WPEM-20025 | 0.25 | 0.01 to 10 |
| Catalog Number | Gel Clot Sensitivity (EU/mL) | Kinetic Turbidimetric Quantitative Range (EU/mL) |
|---|---|---|
| WPEM-50015 | 0.015 | 0.001 to 10 |
| WPEM-50003 | 0.03 | 0.01 to 10 |
| WPEM-50006 | 0.06 | 0.01 to 10 |
| WPEM-50125 | 0.125 | 0.01 to 10 |
| WPEM-50025 | 0.25 | 0.01 to 10 |
PYROSTAR™ ES-F /PLATE
This multi-test vial format is specifically designed for use with microplate readers. The assay procedure in this format involves dispensing 0.05 mL of the sample into a microplate well and subsequently adding 0.05 mL of the reconstituted LAL reagent. This assay method is particularly well-suited for processing a high throughput of samples.
| Catalog Number | Gel Clot Sensitivity (EU/mL) | Kinetic Turbidimetric Quantitative Range (EU/mL) |
|---|---|---|
| WPEPK4-20015 | 2.0 | 0.01 to 10 |
| WPEPK4-50015 | 5.2 | 0.01 to 10 |
| Número de catálogo | Volumen (mL) | Rango Cuantitativo Cinético Turbidimétrico (UE/mL) |
|---|---|---|
| WPEPM-20015 | 2,0 | 0.01 a 10 |
| WPEPM-50015 | 5,2 | 0.01 a 10 |
LIMULUS COLOR KY SERIES
The Limulus Color KY series offers quantitative kinetic chromogenic assays (KCA) specific for endotoxins that do not react with (1,3)-β-D-glucan. This series includes a multi-assay kit and a single-assay kit, which utilize a synthetic substrate that produces a yellow color to detect endotoxins with high sensitivity. All reagent kits are matched with Control Standard Endotoxins (CSE). These reagents work well with turbid samples or samples that present quantification difficulties with the Kinetic Turbidimetric Assay (KTA).
LIMULUS COLOR KY SINGLE TEST
The Limulus Color KY single-assay vials come with LAL reagent pre-dispensed for a single measurement. This configuration is used by adding 0.2 mL of the sample directly to the reaction vial containing the lyophilized reagent. The 1 single-assay vial is ideal for a user performing assays on a smaller number of samples or a less experienced user.
| Catalog Number | Kinetic Chromogenic Quantitative Range (EU/mL) | Number of Tests |
|---|---|---|
| 291-53601 | 0.0002 to 5 | 25 tests |
LIMULUS COLOR KY MULTI TEST
Limulus Color KY single-assay vials come with LAL reagent pre-dispensed for a single measurement. This configuration is used by adding 0.2 mL of the sample directly to the reaction vial containing the lyophilized reagent. The 1 single-assay vial is ideal for users performing assays on a smaller number of samples or less experienced users.
| Catalog Number | Kinetic Chromogenic Quantitative Range (EU/mL) | Number of Tests |
|---|---|---|
| 291-53101 | 0.0005 to 5 | 60 tests |
LIMULUS PS SINGLE TEST
The Limulus PS single test contains single-test vials specific for LAL endotoxins and an affinity resin suspension known as PyroSep™, designed to overcome product interference by adsorbing potential endotoxins in the samples while removing inhibitory components.
Practical Applications: Using the Limulus PS Single Assay
Endotoxin Detection in Peritoneal Dialysate/Replacement Fluid
Two different concentrations of Endotoxin Reference Standard were added to 5 mL samples of commercially available dialysate (dialysate X) and two types of replacement fluids for dialyzers (fluids Y and Z): 0.1 EU/mL and 1.0 EU/mL. The samples were analyzed using the PyroSep™ method. All endotoxin additions showed recovery within an acceptable range of 50-200%.
Endotoxin Recovery from Peritoneal Dialysate/Replacement Fluid Using the PyroSep™ Method
| SAMPLE | ENDOTOXIN SPIKE (EU/mL) | ENDOTOXIN RECOVERY (%) |
|---|---|---|
| Dialysate X | 0.1 | 80 |
| Dialysate X | 1.0 | 72 |
| Fluid Y | 0.1 | 144 |
| Fluid Y | 1.0 | 102 |
| Fluid Z | 0.1 | 108 |
| Fluid Z | 1.0 | 118 |
| Catalog Number | Contents |
|---|---|
| 299-54501 | -20 LAL ES single-test vials
-PyroSep™ resin suspension -LAL reconstitution solution -Wash solution -Sample diluent -20 glass capillary columns |
| Catalog Number | Contents |
|---|---|
| 294-33311 | -12 syringes (20 mL)
-12 T-shape stopcocks R Type -20 Dedicated adapters -12 Bulldog clips -25 Polystyrene tubes (5 mL) -25 Polystyrene tubes (14 mL) -Test tube rack |
PYROSTAR™ Neo is based on a genetic engineering principle to produce the reactive factors necessary for endotoxin detection at medical device and pharmaceutical manufacturing sites. It also facilitates the same sensitivity in endotoxin detection as our Limulus Amebocyte Lysate (LAL) reagent, PYROSTAR™ ES-F.
This reagent uses the Kinetic Chromogenic Assay (KCA) to measure endotoxin content. It is composed of recombinant reactive factors equivalent to Factor C, Factor B, and a proclotting enzyme, which constitute the natural endotoxin reaction system of the horseshoe crab, enabling endotoxin detection with the same sensitivity as the LAL reagent. Furthermore, the absence of Factor G eliminates interference due to reaction with β-glucan, improving specificity.
PYROSTAR™ Neo is a new line of endotoxin detection reagents developed using recombinant technology. It mimics traditional LAL reagents with three recombinant factors (Factor C, Factor B, and proclotting enzyme) and the pNA chromogenic group. It offers an assay with high sensitivity and specificity for endotoxin detection.
SLP-HS II SINGLE REAGENT KIT
Quantitative determination of peptidoglycan (PG) and (1->3)-β-D-glucan (BDG) in parenteral solutions and active pharmaceutical ingredients.
The SLP-HS II Single Reagent Kit is capable of detecting both peptidoglycan (PG) and (1->3)-β-D-glucan (BDG). The product utilizes a self-defense mechanism found within the hemolymph of the 1 Bombyx mori silkworm, which causes a color change by generating a black melanin pigment in the presence of microbial contamination. Since PG is found in all bacterial cell walls 2 and BDG in most fungi, the SLP (silkworm 3 larval plasma) reagent constitutes a high-sensitivity, broad-spectrum method for detecting microbial contamination.
| Número de Catálogo | Nombre de Producto | Número de Ensayos |
|---|---|---|
| 296-81001 | Juego de Reactivos Único SLP-HS II | 20 ensayos |
FUJIFILM Wako provides analysis systems with user-friendly software capable of performing all LAL assay methodologies.
αBET™ RAPID ENDOTOXIN DETECTION SYSTEM
The CMD αBET™ system is a fully integrated testing system that provides a rapid and sustainable solution for endotoxin testing without compromising sensitivity or performance. Utilizing our FDA-licensed Limulus Amebocyte Lysate (LAL) turbidimetric reagent, quantitative results are provided in less than half the time of other test formats, with reduced reagent consumption and minimal user intervention.
| Número de Catálogo | Nombre de Producto | Contenidos |
|---|---|---|
| CMD-A-0007-EN | Instrumento CMD αBET™ | Cable de alimentación, adaptador universal, manual de usuario, tarjetas con código de barras |
| CMD-A-0006-C | Paquete de consumibles CMD αBET™ | 25 cartuchos + 5 reactivos CMD |
TOXIMASTER® QC8 SOFTWARE
Toximaster® QC8 software supports data processing based on protocols compliant with three pharmacopoeias (USP, EP, JP) for bacterial endotoxins tests. This software complies with FDA 21 CFR Part 11 ERES (Electronic Records/Electronic Signatures), which requires accurate record-keeping of all parties involved in sample testing. Toximaster® QC8 offers excellent audit trail capabilities, can provide statistical processing of means and standard deviations, and has robust data processing functions. These data processing functions can be applied by defining sample types such as standards, controls, and test samples.
| Catalog Number | Model | Contents |
|---|---|---|
| 297-35981 | Part 11 software PC set | Toximaster® QC8 Software with 1 Personal Computer |
| 293-35961 | Part 11 software only | Toximaster® QC8 Software |
| Catalog Number | Model | Contents |
|---|---|---|
| 292-35931 | Part 11 software PC set | Toximaster® QC8 Software with 1 Personal Computer |
| 290-35971 | Part 11 software only | Toximaster® QC8 Software |
TOXINOMETER® ET-7000 – ENDOTOXIN MEASUREMENT SYSTEM
The Toxinometer® ET-7000 is a computer-operated kinetic incubating tube reader designed for exceptional ease of use. Our state-of-the-art expansion modules can be connected to enable endotoxin testing across a wide range of applications and sample quantities.
The Toxinometer® ET-7000 works well with all LAL assay methodologies (Gel-Clot, Kinetic Turbidimetric, and Kinetic Chromogenic assays). The instrument has 16 wells in a single-test configuration to easily detect erroneous readings or contamination associated with each well. The kinetic incubating tube 1 reader has two uniform temperature settings of 30 °C and 37 °C.
| Catalog Number | Model | Power Source | Contents |
|---|---|---|---|
| 294-35871 | Toxinometer® ET-7000/U Part 11 Set | 100–120 ± 10% VAC (USA) | – 1 Toxinometer® ET-7000 – Toximaster® QC8 Software – 1 Personal Computer – System Validation Doc. |
| 299-35821 | Toxinometer® ET-7000/E Part 11 Set | 220–240 ± 10% VAC (Europe) | – 1 Toxinometer® ET-7000 – Toximaster® QC8 Software – 1 Personal Computer – System Validation Doc. |
| Catalog Number | Catalog Number | Power Source | Contents |
|---|---|---|---|
| 297-35861 | Toxinometer® ET-7000/U Expansion Module | 100–120 ± 10% VAC (USA) | 16-well expansion unit |
| 294-35811 | Toxinometer® ET-7000/E Expansion Module | 220–240 ± 10% VAC (Europe) | 16-well expansion unit |
BIOTEK MICROPLATE READERS
BioTek microplate readers provide great flexibility for handling and analyzing your data. These multi-channel readers continue BioTek’s tradition of offering the tightest specifications of any microplate reader, ensuring accurate and repeatable results. The ELx808 features a superior 4-zone™ incubator, which provides excellent stability for temperature-sensitive assays such as endotoxin analysis and long-term bacterial and yeast growth studies. FUJIFILM Wako now offers you a highly precise instrument with convenient, portable, and specifically designed software for LAL assays.
| Catalog Number | Model | Contents |
|---|---|---|
| BIOT-808IU | ELx808 | – 1 BioTek ELx808 unit |
| Catalog Number | Model | Contents |
|---|---|---|
| BIOT-35931 | ELx808 | – 1 BioTek ELx808 unit
– 1 Personal Computer – Toximaster® QC8 Software |
| Número de Catálogo | Modelo | Contenidos |
|---|---|---|
| BIOT-800GS | 800TS | -1 Unidad BioTek 800TS |
FUJIFILM Wako offers a collection of endotoxin-free accessories including pipette tips, microplates, test tubes, caps, and LAL reagent water designed for hassle-free endotoxin testing.
BIOCLEAN SERIES – PIPETTE TIPS
BioClean series pipette tips and microplates are endotoxin-free. These micropipette tips and microplates are individually wrapped to reduce the possibility of contamination and are perfect for all types of LAL assays. Wako® BioCleanTips are available in 200 µL and 1000 µL volumes, with the 200 µL volume offered in standard and extended sizes. Extend S tips are used for taking multiple assay reagent aliquots in gel-clot reaction tubes, Limulus-S test tubes, or BioCleanPlate Wako™. This pipette tip can deliver the reagent to the bottom of the tubes/wells without introducing contamination.
| Catalog Number | Product Name | Volume Size | Quantity |
|---|---|---|---|
| 291-35021 | BioCleanTip Wako® 200 II | 200 µL/tip | 100 tips |
| 298-35031 | BioCleanTip Wako® 1000 II | 1000 µL/tip | 100 tips |
| 294-35011 | BioCleanTip Wako® Extend S | 200 µL/tip | 100 tips |
| 293-35221 | BioCleanPlate Wako™ | 96 wells/plate | 50 plates |
LAL REAGENT WATER
LAL reagent water can be used for all aspects of endotoxin assays. LAL reagent water provides reliable and reproducible data when combined with our specific endotoxin LAL reagents, from the reconstitution of CSE and LAL for the preparation of standard curves to product dilutions.
| Catalog Number | Product Name | Quantity |
|---|---|---|
| LRW-12100 | LAL Reagent Water, 100 mL | 12 x 100 mL glass bottles |
| LRW-2030 | LAL Reagent Water, 30 mL | 20 x 30 mL glass bottles |
| LRW-12125 | LAL Reagent Water, 125 mL | 12 x 125 mL plastic bottles |
GEL-CLOT REACTION TUBES
Our gel-clot reaction tubes are manufactured from high-quality borosilicate glass and depyrogenated at 250°C. This provides you with an endotoxin-free tube designed for accurate LAL gel-clot assays using heating blocks and water baths.
| Catalog Number | Product Name | Quantity |
|---|---|---|
| CT-1075 | 10 x 75 mm Borosilicate Test Tubes | 200 tubes/pkg |
| CT-1075B | 10 x 75 mm Borosilicate Test Tubes, Bulk | 1250 tubes/pkg |
LIMULUS TEST TUBE-S
Our specialized Limulus Test Tube-S tubes are manufactured from high-quality borosilicate glass and depyrogenated at 250°C. These tubes feature a special curvature that allows the appropriate amount of light to transmit through the sample to measure endotoxin concentration according to the method used. These glass tubes are designed for the Toxinometer® measurement system.
| Catalog Number | Product Name | Dimensions | Quantity |
|---|---|---|---|
| 292-32751 | Limulus Test Tube-S with Aluminum Cap | 12 x 75 mm | 80 caps/tubes |
| 293-26551 | Limulus Test Tube-S | 12 x 75 mm | 100 tubes |
DEPYROGENATED DILUTION TUBES
Our depyrogenated dilution tubes are manufactured from high-quality borosilicate glass and depyrogenated at 250°C. This provides you with endotoxin-free tubes capable of accurate LAL dilution series, from standard curve creation to sample dilutions, with minimal potential for contamination.
| Catalog Number | Product Name | Quantity |
|---|---|---|
| DL-13100 | 13 x 100 mm Borosilicate Test Tubes | 50 tubes |
ALUMINUM CAPS
Our aluminum caps help reduce potential contamination by preventing any additional substances or materials from accessing the test tubes.
| Catalog Number | Product Name | Dimensions | Quantity |
|---|---|---|---|
| 293-28251 | Aluminum Cap-S | 14.7 x 18 mm | 100 caps/pkg |
Our endotoxin assay-related products are additional specialized kits that aid in the successful performance of bacterial endotoxin assays.
CONTROL STANDARD ENDOTOXIN
Our control standard endotoxin is a lyophilized product composed of 500 ng of endotoxin, purified from the UKT-B strain of E. coli, serving as a standard for endotoxin assays.
| Catalog Number | Contents |
|---|---|
| CSE4037-5006 | 6 vials (500 ng/vial) |
LPS FOR ENDOTOXIN INDICATORS
LPS for endotoxin indicator is composed of E. coli O55:B5 (>100,000 EU/vial) and serves as a stock solution for preparing multiple endotoxin indicators for depyrogenation validation studies. Prepared endotoxin indicators can be assayed using reagents from our PYROSTAR™ ES-F series.
| Catalog Number | Contents |
|---|---|
| WLPS-0100K | 6 vials (>100,000 EU/vial) |
ES BUFFER
The ES buffer is an endotoxin-specific buffer ideal for untreated LAL. While all LAL reagents produced by FUJIFILM Wako are endotoxin-specific, other commercially available LAL reagents are not. Without this 1 buffer, assays may activate (1,3)-β-D-glucan when attempting to determine the endotoxin concentration in the sample.
| Catalog Number | Contents |
|---|---|
| ESB-0006 | 6 vials x 5.2 mL |
ENDOTOXIN EXTRACTION SOLUTION
Traditionally, water or saline solution was used to extract endotoxins in assays with medical devices or equipment. However, the effectiveness of this extraction method is currently being debated. To provide our customers with a more reliable method, FUJIFILM Wako has developed a solution containing human serum albumin (HSA) capable of extracting endotoxins that cannot be extracted with water or saline.
| Catalog Number | Contents |
|---|---|
| 293-51601 | 4 vials x 10 mL |
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