En Do Toxin Catalog
Content
Endotoxin Detection Products
1-800-638-8174 www.cambrex.com/LAL
Revised 7-04 CAT-LAL-1, 07/04
Endotoxin Detection
History of Endotoxin Detection ..........................................................3 About Cambrex..................................................................................4 Gel Clot Assays .................................................................................5 Kinetic Assays....................................................................................9 PyroGene® Recombinant Factor C Assay........................................11 Chromogenic End-Point Assays ......................................................12 Instrumentation and Software..........................................................13 Accessory Products .........................................................................15 Testing Services...............................................................................16 Testing Services – Pre-Paid Europe Only .......................................17
NEW
PRODUCTS
PyroGene® Recombinant Factor C Assay........................................11 FLx800™ Fluorescent Microplate Reader.........................................13 PyroTherm Pyrogen Monitoring System..........................................13 WinKQCL® Software V 3.00.............................................................14 Eppendorf BioPur® Pipette Tips .......................................................15 Stepped Neutral Density Plate ........................................................15
Products manufactured by Cambrex Bio Science Walkersville, Inc.
1-800-638-8174 www.cambrex.com/LAL
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From Rabbits to Horseshoe Crabs, a Brief History of Endotoxin Detection
Ever since the pharmaceutical industry began manufacturing injectables, pyrogen detection tests have been an absolute necessity. Pyrogens are substances that can cause fever, shock and even death if high levels are introduced into a person’s body. are then returned unharmed to the sea. Next, the crabs’ blood cells (amebocytes) are separated and lysed to obtain the cellular proteins. As LAL became the preferred pyrogen detection test, different methods were developed, each with its own unique benefits. For example, Gel Clot LAL (PYROGENT®) provides a simple positive/negative result and is often mentioned in most pharmacopoeial monographs as the official referee test. Chromogenic End-Point LAL (QCL-1000®) offers a quantitative result and exhibits less product interference than LAL methods utilizing the clotting protein. Kinetic Turbidimetric (PYROGENT®-5000) gives quantitative results and for water and large volume parenterals, it offers an economical choice. Kinetic Chromogenic LAL (Kinetic-QCL®) provides automation and greater sensitivity detecting as low as 0.005 EU/mL. Currently the FDA, the United States Pharmacopoeia (USP), the European Pharmacopoeia (EP) and the Japanese Pharmacopoeia (JP) accept all of the above LAL methods, as do most individual country pharmacopoeias. For most of the 20th Century, the Rabbit Pyrogen Test was the standard method of testing for pyrogenicity. This test, which takes approximately four hours, is accomplished by injecting the drug being analyzed into a rabbit’s ear. If the animal develops a fever, it confirms the presence of pyrogens. The Limulus Amebocyte Lysate (LAL) test was commercially introduced during the 1970’s. In a notice published in the Federal Register on November 4, 1977, the FDA described conditions for the use of LAL as an end-product test for endotoxin in human biological products and medical devices. The FDA noted, it is widely recognized that the LAL test is faster, more economical and requires a smaller volume of product than does the rabbit pyrogen test. In addition, the procedure is less labor intensive than the rabbit test, making it possible to perform many tests in a single day. To obtain the lysate required for the LAL test, horseshoe crabs are taken from the ocean floor and a small amount of their blood is drawn. The animals The latest development in endotoxin detection technology is PyroGene®. This innovative product is a recombinant form of Factor C, the first component in the Limulus clotting cascade. PyroGene promises to reduce the dependence on animal-based endotoxin assays.
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About Cambrex
Cambrex Bio Science Walkersville, Inc. is the industry leader in sales and innovations for endotoxin detection products, services and software. First to commercialize quantitative chromogenic LAL… first to use polynomial regression… first to develop a recombinant endotoxin-activated detection method… first to use fluorescence in an endotoxin activation assay… first on-line endotoxin detection method for WFI… first in quality… first in compliance… first in customer relations. At Cambrex, we are focused on your endotoxin testing requirements – now and in the future.
Cambrex Bio Science Verviers, S.P.R.L.
32-87-32-16-11 • Fax: 32-87-35-19-67 [email protected]
Cambrex Bio Science Wokingham, Ltd.
44-118-979-5234 • Fax: 44-118-979-5231 [email protected]
Cambrex Bio Science Milano, S.P.R.L.
39-0363-35-14-70 • Fax: 39-0363-35-14-75
Cambrex Bio Ciencia Brasil Ltda.
55-11-5180-3677 • Fax: 55-11-5180-3648
Cambrex Chemicals Pvt. Ltd. (India)
91-22-5697-2883/84/85 • Fax: 91-22-5697-2888 [email protected]
Technical Service
Cambrex endotoxin detection expertise is just a phone call away. Our dedicated technical specialists are always ready to answer your endotoxin testing-related questions. For assistance in your lab, our technical sales force is available through a world-wide network. Workshops are conducted throughout this network to supply both the novice and the experienced LAL user with answers to the most difficult challenges. With over 20 years of LAL experience, Cambrex will provide you with the best technical support in the industry. For questions regarding the endotoxin detection assays, please contact our Technical Service Specialists. U.S. and other non-European locations, call (800) 654-4452 or (301) 898-7025 ext. 7822 or e-mail [email protected] Fax: (301) 852-5663 for U.S. and other non-European locations European customers can e-mail [email protected] Or, visit our web site at www.cambrex.com/LAL
Sales & Customer Service
Our customer service department is filled with tenacious problem solvers who are pleased to find the answers to your questions and to assist you with your order.
Cambrex Bio Science Walkersville, Inc.
8830 Biggs Ford Road • Walkersville, MD 21793 (888) 403-8772 or (301) 898-7025 Fax: (301) 845-8708 for domestic orders and (301) 845-8291 for international orders. www.cambrex.com • [email protected]
Kinetic-QCL, QCL-1000, PYROGENT, PyroGene and WinKQCL are registered trademarks of Cambrex Bio Science Walkersville, Inc. ELx808, ELx808R and FLx800 are trademarks of Bio-Tek. BioPur is a registered trademark of Eppendorf International, Inc. © 2004, Cambrex, Inc.
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Gel Clot Assays
PYROGENT® Gel Clot LAL
The PYROGENT Gel Clot Assay is a qualitative LAL test for Gram-negative bacterial endotoxin. PYROGENT is available as a lysate kit with sensitivities of 0.03, 0.06, 0.125 and 0.25 EU/mL. Standard kit sizes include 250 and 80 tests, and a 25-test kit in a single test vial format is available. These kits do not include a matched control standard endotoxin. However, the standard can be purchased separately (see Gel Clot Accessory Products, page 8). A Certificate of Quality is included with each kit. STORAGE CONDITIONS • 2°C – 8°C.
PYROGENT
Cat. No. F209 Size 50 tests Sensitivity EU/mL 0.06, 0.125, 0.25
Contains: 1 x 50 tests/vial of lysate
Complete 20 Test Kit
Cat. No. 50-500U-06 50-500U-12 Size 20 tests 20 tests Sensitivity EU/mL 0.06 0.125
ORDERING INFORMATION
PYROGENT
Cat. No. N104 N183-06 N184-06 N183-125 N184-125 N183-25 N184-25 Size 250 tests 80 tests* 250 tests** 80 tests 250 tests 80 tests 250 tests Sensitivity EU/mL 0.03 0.06 0.06
Contains: 22 single test vials 5 inhibition control vials 1 positive control vial 1 x 5 mL vial LAL reagent water 28 pipettes 1 sheet of labels
Limulus Amebocyte Lysate Control Kit
Cat. No. 50-510U Size 5 tests
0.125 0.125 0.25 0.25 Contains: 5 positive control vials 5 negative control vials
Inhibition Control
Cat. No. 50-506U Size 5 single test vials
*80 tests = Contains: 5 x 16 tests/vial of lysate **250 tests = Contains: 5 x 50 tests/vial of lysate
PYROGENT (Single Test Vials)
Cat. No. N189-03 N189-06 N189-125 N189-25 Size 25 tests 25 tests 25 tests 25 tests Sensitivity EU/mL 0.03 0.06 0.125 0.25
Contains: 25 single test vials of lysate
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Gel Clot Assays
PYROGENT® Plus Gel Clot LAL
The PYROGENT Plus Gel Clot Assay combines PYROGENT LAL with a matched control standard endotoxin. The Certificate of Quality documenting the FDA and USP required RSE/CSE correlation is included in each kit. PYROGENT Plus kits are available with sensitivities of 0.03, 0.06, 0.125 and 0.25 EU/mL. Standard kit sizes are 200 and 64 tests. Bulk configurations containing 4,000 tests are also available. STORAGE CONDITIONS • 2°C – 8°C.
PYROGENT Plus Single Test Vials
Cat. No. N289-03 N289-06 N289-125 N289-25 Size 24 tests 24 tests 24 tests 24 tests Sensitivity EU/mL 0.03 0.06 0.125 0.25
Contains: 1 x 1 mL vial endotoxin 24 single test vials of lysate
ORDERING INFORMATION
PYROGENT Plus
Cat. No. N204 N283-06 N284-06 N283-125 N284-125 N283-25 N284-25 Size 200 tests 64 tests 200 tests 64 tests 200 tests 64 tests 200 tests Sensitivity EU/mL 0.03 0.06 0.06 0.125 0.125 0.25 0.25
Contains: 1 x 10 ng/vial endotoxin 64 Tests = Contains: 4 x 16 tests/vial of lysate 200 Tests = Contains: 4 x 50 tests/vial of lysate
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Gel Clot Assays
Gel Clot Bulk Configurations
Bulk configurations are available for those laboratories using large volumes of reagents. These configurations are made to order, and production lead times are required. Please inquire for more information:
ORDERING INFORMATION
PYROGENT® Plus Bulk Kit
Cat. No. N488 N288-06 N288-125 N288-25 Size 4,000 tests 4,000 tests 4,000 tests 4,000 tests Sensitivity EU/mL 0.03 0.06 0.125 0.25
Contains: 20 x 10 ng/vial endotoxin 80 x 50 tests/vial of lysate
Bulk Lysate
Cat. No. E203L E203U E209L E209U F245U Size 25 x 50 test/vial 100 x 50 test/vial 25 x 50 test/vial 100 x 50 test/vial 100 x 16 test/vial Sensitivity EU/mL 0.03 0.03 0.06, 0.125, 0.25 0.06, 0.125, 0.25 0.06, 0.125, 0.25
Bulk Endotoxin
Cat. No. 7360L Size 25 vials, 10 ng/vial
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Gel Clot Assays
PYROGENT® Ultra Gel Clot LAL
The PYROGENT Ultra Gel Clot Assay contains a series of convenient pre-mixed liquid endotoxin standards at the concentrations necessary to create a standard curve. Designed to increase your productivity in the lab, these liquid endotoxin standards decrease time, hassle and potential human error by eliminating the need for dilution and vortexing. A Certificate of Quality is included with each kit. STORAGE CONDITIONS • 2°C – 8°C.
ORDERING INFORMATION
Gel Clot Accessory Products
Cambrex’s Control Standard Endotoxin is referenced against the USP Reference Standard Endotoxin following the procedures set forth in the Guidelines on Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices. Certificates of Quality showing potency are available upon request. STORAGE CONDITIONS • 2°C – 8°C.
PYROGENT Ultra
Cat. No. N403 N406 N412 Size 200 tests 200 tests 200 tests Sensitivity EU/mL 0.03 0.06 0.125
Contains: 5 x 5 mL gel clot liquid endotoxin standards (2 λ, λ, 0.5 λ, 0.25 λ, 20 λ) 4 x 50 tests/vial of lysate
ORDERING INFORMATION
Endotoxin (E. coli)
Strain O55:B5 Cat. No. N185 N186 Size 5 vials x 2.5 mg/vial 5 vials x 10 ng/vial
Endotoxin Challenge Vials
Cat. No. N187 Size 25 vials
Used for oven validations E. coli endotoxin (>1,000 EU/vial)
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Kinetic Assays
PYROGENT®-5000 Turbidimetric LAL
PYROGENT-5000 is a quantitative, kinetic assay for the detection of Gram-negative bacterial endotoxin. This assay has a sensitivity range from 100 EU/mL to 0.01 EU/mL and is ideal for testing water samples, large volume parenterals, and medical devices. The PYROGENT-5000 assay is performed in a 96-well plate allowing for high-throughput processing. The use of an incubating plate reader is required for this assay to measure change in turbidity (see Instrumentation and Software, page 13). The sample reaction times are then plotted against a standard curve to calculate endotoxin concentration. A Certificate of Quality is included in each kit. STORAGE CONDITIONS • 2°C – 8°C. N688
PYROGENT®-5000 Bulk Configurations
Bulk Configurations are available for those laboratories using large volumes of reagents. These configurations are made to order, and production lead times are required. Please inquire for more information.
ORDERING INFORMATION
Cat. No. N588 Description Sensitivity (EU/mL)
2,250 tests 0.01 – 100 Contains: 45 x 50 tests/vial lysate 45 vials reconstitution buffer 10 x 50 ng/vial endotoxin 4,500 tests 0.01 – 100 Contains: 45 x100 tests/vial lysate 45 vials reconstitution buffer 10 x 50 ng/vial endotoxin
ORDERING INFORMATION
PYROGENT-5000 Turbidimetric LAL
Cat. No. N383 N384 Size Sensitivity (EU/mL) 0.01 – 100 0.01 – 100 100 tests (2 x 50 tests/vial lysate) 200 tests (2 x 100 tests/vial lysate)
Contains: Lysate 2 vials reconstitution buffer 1 x 50 ng/vial endotoxin
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Kinetic Assays
Kinetic-QCL® Chromogenic LAL
Kinetic-QCL is a quantitative, kinetic assay for the detection of Gram-negative bacterial endotoxin. It is the most sensitive of the LAL assays, having a sensitivity range from 50 EU/mL to 0.005 EU/mL. Kinetic-QCL is ideal for testing small volume parenterals, vaccines, antibiotics, and biologicals. This assay is performed in a 96-well plate allowing for high-throughput processing. The sample reaction times are then plotted against a standard curve to calculate endotoxin concentration. An incubating plate reader is required for this assay (see Instrumentation and Software, page 13). A Certificate of Quality is included in each kit. STORAGE CONDITIONS • 2°C – 8°C.
Kinetic-QCL Bulk Configurations
Bulk Configurations are available for those laboratories using large volumes of reagents. These configurations are made to order, and production lead times are required.
ORDERING INFORMATION
Please inquire for pricing and more information. Cat. No. K50-643L Description Sensitivity (EU/mL)
600 tests 0.005 – 50 Contains: 25 x 24 tests/vial lysate 2,400 tests 0.005 – 50 Contains: 100 x 24 tests/vial lysate
K50-643U
ORDERING INFORMATION
Kinetic-QCL Chromogenic LAL
Cat. No. 50-650U Size 192 tests Sensitivity (EU/mL) 0.005 – 50
Endotoxin
Cat. No. E50-643L Description 25 x 10 ng/vial endotoxin
Contains: 8 x 24 tests/vial of Kinetic-QCL lysate 2 x 10 ng/vial endotoxin 3 x 30 mL vials LAL reagent water
Lysate and Endotoxin
Cat. No. 50-650 NV Description Sensitivity (EU/mL) 2,040 tests 0.005 – 50 Contains: 85 x 24 tests/vial lysate 15 x 10 ng/vial endotoxin 2,400 tests 0.005 – 50 Contains: 100 x 24 tests/vial lysate 10 x 10 ng/vial endotoxin
50-650H
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PyroGene Recombinant Factor C Assay
®
PyroGene Recombinant Factor C Endotoxin Detection System represents another first from the endotoxin detection technology leader. Our scientists have produced a recombinant form of Factor C, the first component in the Limulus clotting cascade activated by endotoxin. Once again, Cambrex leads the way with evolutionary technology that promises to reduce the dependence on animal-based endotoxin assays.
Figure 2: The rFC Assay and LAL Assays Measure Similar Endotoxin Potency in Purified LPS
Advantages of PyroGene:
• Greater endotoxin specificity • Elimination of false positive glucan reactions • Less lot-to-lot variability • No animal utilization
PyroGene represents a reliable, environmentally friendly alternative to LAL. We at Cambrex invite you to experience the PyroGene alternative.
Figure 1: rFC Endotoxin Standard Curves Using 4 Different Lots of rFC
Similar endotoxin potency is detected in purified lipopolysaccharides using PyroGene®, Kinetic-QCL® and PYROGENT®-5000 assays. STORAGE CONDITIONS • 2°C – 8°C.
ORDERING INFORMATION
PyroGene Recombinant Factor C Assay
Cat. No. 50-658U Size 192 tests
NEW
Sensitivity (EU/mL) 0.01 – 10
For the instrumentation and software see page 13.
Recombinant Factor C (rFC) is activated by endotoxin binding, and the active moiety created then acts to cleave a synthetic substrate which results in the generation of a fluorogenic compound. The reaction is run in a 96-well microplate and measured at time zero and after a one-hour incubation in a fluorescent microplate reader using excitation/emission wavelengths of 380/440 nm. The log net fluorescence is proportional to the log endotoxin concentration and is linear in the 0.01 – 10 EU/mL range. Lot-to-lot standard curves exhibit excellent reproducibility.
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Chromogenic End-Point Assays
QCL-1000® Chromogenic End-Point LAL
QCL-1000, the most rapid of the LAL tests, is a 16 minute, quantitative endpoint assay that has a sensitivity range from 1.0 EU/mL to 0.1 EU/mL. This chromogenic assay forms a yellow color and is measured photometrically at 405 – 410 nm. With QCL-1000, a multichannel pipette and a 96-well plate, you can run 96 reaction wells at one time. This assay can also be run in tubes. A Certificate of Quality is included in each kit. STORAGE CONDITIONS • 2°C – 8°C.
ORDERING INFORMATION
QCL-1000 Chromogenic End-Point LAL
Cat. No. 50-647U Size Sensitivity (EU/mL) 120 tests 0.1 – 1.0 Contains: 5 x 1.4 mL lysate 1 x 1 mL vial endotoxin 2 x 30 mL vials LAL Reagent Water 2 x 6.5 mL chromogenic substrate 300 tests 0.1 – 1.0 Contains: 5 x 3 mL lysate 2 x 1 mL vial endotoxin 5 x 6.5 mL chromogenic substrate
QCL-1000® Accessory Products
Endotoxin
Strain 0111:B4 Cat. No. E50-640 Size 1 x 1 mL vial endotoxin Approximately 15 – 40 EU/mL
50-648U
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Instrumentation and Software
Standard Kinetic System
This system comes complete with all of the hardware and software needed to run the kinetic quantitative LAL assays. Cat. No. 25-335 Includes: Dell computer with Pentium IV Microprocessor Software: Windows 2000®, WinKQCL® software Flat Panel 15.0 inch viewable monitor HP laserjet® 1300 (or equivalent) Bio-Tek® ELx808™ incubating 96-well plate reader Stepped neutral density plate
® ™
FLx800™ Fluorescent Microplate Reader with Ex/Em 380/440
Cat. No. 25-344 UV-Vis filter fluorometer for reading and incubation of 96-well microplates. Works with WinKQCL® Software V 3.00.
NEW
High Throughput System
Robotic workstations to completely automate LAL testing are available and can be tailored to your needs.
PyroTherm Pyrogen Monitoring System
NEW
Bio-Tek ELx808 Incubating Reader
Cat. No. 25-315 UV-Vis filter spectrophotometer for reading and incubation of 96-well microplates. Works with WinKQCL Software.
PyroTherm is a computer integrated, high performance, programmable heat block. This equipment is designed for a broad range of temperatures, from 5°C – 300°C, but has been optimized for the LAL gel clot test. PyroGel software is a 21 CFR Part 11 compliant software package designed to work with the PyroTherm unit. The software offers temperature profiling during an assay, as well as integrated sample management with sample tracking and automatic calculation and reporting. In addition, depyrogenation of test tubes can be done using the heat block. Cat. No. 25-347
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Instrumentation and Software
WinKQCL® Software V 2.00
WinKQCL is the industry leading software application designed to manage, analyze, and report kinetic LAL assay data. It features compliance with 21 CFR Part 11 for electronic records and signatures, provides efficiency with a trending database, validation support, and bar code reading. Cat. No. 25-301
WinKQCL® Software V 3.00
NEW
Our newest version of WinKQCL continues to be compliant with 21 CFR Part 11 regulations. We have built in the ability to share databases over a network in a client/server interface. Test results can now be exported to a LIMS database. The software will also support our new PyroGene® assay and will interface with the FLx800™ Reader.
Client/Server Version IQ/OQ/PQ Manual for V 2.00
Installation, operational, and performance qualification manual for documented installation of the system. Cat. No. 25-338M Cat. No. 25-348
Additional Software License
(required for multiple workstations) Cat. No. 25-353
Validation Manual for V 2.00
This notebook features over 500 documented test cases used to validate the software. Cat. No. 25-341
IQ/OQ/PQ Manual for Kinetic LAL System WinKQCL V 3.00
Cat. No. 25-349
System Qualification Service
A trained specialist from Cambrex performs the installation, operation, and performance qualification of the Kinetic System. Cat. No. 25-339S
Validation Manual for WinKQCL V 3.00
Cat. No. 25-350
IQ/OQ/PQ Manual for PyroGene®
Cat. No. 25-354
Assay Plate
Template Manager
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Accessory Products
LAL Accessory Products
Reagents
Name ß-G-Blocker Pyrosperse MgCl2 Tris Buffer LAL Reagent Water Cat. No. N190 N188 S50-641 S50-642 W50-640 W50-100 W50-500 Size 5 x 5 mL vials 5 x 5 mL vials 30 mL vial 30 mL vial 30 mL 100 mL 500 mL Storage Conditions 2°C – 8°C 2°C – 30°C 2°C – 30°C 2°C – 30°C 2°C – 8°C 15°C – 30°C 15°C – 30°C Comments Used to block glucan interference Dispersing agent 10 mM Solution 50 mM Solution <0.005 EU/mL
Labware
Name Pyrogen-free Test Tubes Pyrogen-free Test Tubes Pyrogen-free Dilution Tubes Reagent Reservoir Sample Container, Depyrogenated Cat. No. N201 N205 N207 25-268 80-507 80-507L 80-507U 25-415 25-416 25-417 25-342 25-038 10 mL Size 10 x 75 mm 10 x 75 mm 13 x 100 mm Quantity 50/pkg 50/pkg 30/pkg 10/pkg Each 25/box 100/box 5 trays/pkg; 96 tips/tray Comments W/polypropylene screw caps Foil wrapped without caps Foil wrapped without caps For use with 8-channel pipettes Glass bottles with screw caps
NEW Eppendorf BioPur®
Pipette Tips Stepped Neutral Density Plate Ground Aluminum Block with Lid
200 µL 300 µL 1,000 µL
Only for multichannel pipettors
NEW
For use in ELx808™, ELx808R™, and Kinetic-QCL® plate readers. Calibrated against NIST traceable standards. Each 50/case Holds a 96-well plate in a dry bath multiblock heater 96-well, <0.0005 EU/well
LAL Reagent Grade Plates 25-340
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Testing Services
Endotoxin Detection Testing Service Information
Our Testing Service offers you the best in routine and customized endotoxin testing. Our facility is GMP compliant and provides expertise in gel clot, kinetic chromogenic and kinetic turbidimetric assays. All testing is performed in accordance with FDA Guidelines. Whether you are from a university research laboratory or a QC lab in a major pharmaceutical company, Cambrex has the capabilities you need for reliable, accurate and confidential results. Please contact the LAL Testing Service to obtain general information and the LAL Information Sheet: Request for In-House Product Testing.
U.S. Testing Service Customers:
(800) 654-4452 • (301) 898-7025 ext. 7820 Fax: (301) 845-4153 e-mail: [email protected]
European Testing Service Customers:
Phone: +32-87-32-16-11 Fax: +32-87-35-19-67 e-mail: [email protected] [email protected]
Sample Shipment:
Cambrex Bio Science Walkersville, Inc. LAL Testing Service (B-06) Central Receiving 8830 Biggs Ford Road Walkersville, MD 21793-0127
Sample Shipment:
Cambrex Bio Science, Verviers Parc Industriel de Petit Rechain B-4800 Verviers Belgium
Testing Services
Type of Test Preliminary Screening of New Product Product Validation Per FDA Guidelines U.S. Cat. No. 80-500 80-501 80-502 Sample Testing Endotoxin Determination Routine Testing FDA End Product Release SOP Writing ß-D-Glucan Testing Custom Depyrogenation Container Depyrogenation Endotoxin Testing w/Recombinant Factor C 80-503 80-509 80-504 80-510 80-512 80-514 — — — Europe Cat. No. 80-500 80-501 80-502 80-503 80-509 80-504 80-510 — 80-511 80-515 80-516 80-517 Endotoxin Challenge Vials w/ Positive Product Controls Endotoxin Testing w/Positive Product Controls Screening Assay w/PyroGene Inhibition/Enhancement Assay Single lot of product 3 lots of product with all lots submitted at one time 1 lot, single sample Each additional lot, single sample 1 lot, 3 samples Each additional lot, 3 samples Description
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Testing Services
Pre-Paid Test Services for Europe
Cambrex European LAL Testing Service offers a mail-in pre-paid testing service for users not requiring testing according to the pharmaceutical or USP medical device regulations. Pre-paid rapid-endo test packs can be ordered as you would any other product. You will be sent a pre-addressed padded envelope, sample bottles and instructions. Samples can be mailed whenever you have a requirement for an endotoxin test. Samples received using this service are tested at the pre-set dilutions indicated below.
European Testing Service Customers:
Phone: +32-87-32-16-11 Fax: +32-87-35-19-67 e-mail: [email protected] [email protected]
Sample Shipment:
Cambrex Bio Science, Verviers Parc Industriel de Petit Rechain B-4800 Verviers Belgium
European Testing Services
Type of Test Rapid-Endotest single water sample Rapid-Endotest single dialysis fluid sample Rapid-Endotest single research sample Rapid-Endotest for up to five water samples Rapid-Endotest for up to five dialysis fluid samples Rapid-Endotest for up to five research samples Cat. No. 91-101 91-102 91-103 95-101 95-102 95-103 Description Tested neat with positive product control Tested at 1:5 and 1:10 dilutions with positive product controls Tested at 1:10, 1:100 and 1:1000 dilutions with positive product controls Tested neat with positive product controls Tested at 1:5 and 1:10 dilutions with positive product controls Tested at 1:10, 1:100 and 1:1000 dilutions with positive product controls
Sample Type Water Dialysis Fluids Research Samples
Dilutions None (Neat) 1:5, 1:10 1:10, 1:100, 1:1000
Result Range (EU) 0.005 – 50 0.025 – 500 0.05 – 50,000
Result Range (pg) 0.5 – 5,000 2.5 – 50,000 5.0 – 5,000,000
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1-800-638-8174 www.cambrex.com/LAL
Revised 7-04 CAT-LAL-1, 07/04
Endotoxin Detection
History of Endotoxin Detection ..........................................................3 About Cambrex..................................................................................4 Gel Clot Assays .................................................................................5 Kinetic Assays....................................................................................9 PyroGene® Recombinant Factor C Assay........................................11 Chromogenic End-Point Assays ......................................................12 Instrumentation and Software..........................................................13 Accessory Products .........................................................................15 Testing Services...............................................................................16 Testing Services – Pre-Paid Europe Only .......................................17
NEW
PRODUCTS
PyroGene® Recombinant Factor C Assay........................................11 FLx800™ Fluorescent Microplate Reader.........................................13 PyroTherm Pyrogen Monitoring System..........................................13 WinKQCL® Software V 3.00.............................................................14 Eppendorf BioPur® Pipette Tips .......................................................15 Stepped Neutral Density Plate ........................................................15
Products manufactured by Cambrex Bio Science Walkersville, Inc.
1-800-638-8174 www.cambrex.com/LAL
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From Rabbits to Horseshoe Crabs, a Brief History of Endotoxin Detection
Ever since the pharmaceutical industry began manufacturing injectables, pyrogen detection tests have been an absolute necessity. Pyrogens are substances that can cause fever, shock and even death if high levels are introduced into a person’s body. are then returned unharmed to the sea. Next, the crabs’ blood cells (amebocytes) are separated and lysed to obtain the cellular proteins. As LAL became the preferred pyrogen detection test, different methods were developed, each with its own unique benefits. For example, Gel Clot LAL (PYROGENT®) provides a simple positive/negative result and is often mentioned in most pharmacopoeial monographs as the official referee test. Chromogenic End-Point LAL (QCL-1000®) offers a quantitative result and exhibits less product interference than LAL methods utilizing the clotting protein. Kinetic Turbidimetric (PYROGENT®-5000) gives quantitative results and for water and large volume parenterals, it offers an economical choice. Kinetic Chromogenic LAL (Kinetic-QCL®) provides automation and greater sensitivity detecting as low as 0.005 EU/mL. Currently the FDA, the United States Pharmacopoeia (USP), the European Pharmacopoeia (EP) and the Japanese Pharmacopoeia (JP) accept all of the above LAL methods, as do most individual country pharmacopoeias. For most of the 20th Century, the Rabbit Pyrogen Test was the standard method of testing for pyrogenicity. This test, which takes approximately four hours, is accomplished by injecting the drug being analyzed into a rabbit’s ear. If the animal develops a fever, it confirms the presence of pyrogens. The Limulus Amebocyte Lysate (LAL) test was commercially introduced during the 1970’s. In a notice published in the Federal Register on November 4, 1977, the FDA described conditions for the use of LAL as an end-product test for endotoxin in human biological products and medical devices. The FDA noted, it is widely recognized that the LAL test is faster, more economical and requires a smaller volume of product than does the rabbit pyrogen test. In addition, the procedure is less labor intensive than the rabbit test, making it possible to perform many tests in a single day. To obtain the lysate required for the LAL test, horseshoe crabs are taken from the ocean floor and a small amount of their blood is drawn. The animals The latest development in endotoxin detection technology is PyroGene®. This innovative product is a recombinant form of Factor C, the first component in the Limulus clotting cascade. PyroGene promises to reduce the dependence on animal-based endotoxin assays.
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About Cambrex
Cambrex Bio Science Walkersville, Inc. is the industry leader in sales and innovations for endotoxin detection products, services and software. First to commercialize quantitative chromogenic LAL… first to use polynomial regression… first to develop a recombinant endotoxin-activated detection method… first to use fluorescence in an endotoxin activation assay… first on-line endotoxin detection method for WFI… first in quality… first in compliance… first in customer relations. At Cambrex, we are focused on your endotoxin testing requirements – now and in the future.
Cambrex Bio Science Verviers, S.P.R.L.
32-87-32-16-11 • Fax: 32-87-35-19-67 [email protected]
Cambrex Bio Science Wokingham, Ltd.
44-118-979-5234 • Fax: 44-118-979-5231 [email protected]
Cambrex Bio Science Milano, S.P.R.L.
39-0363-35-14-70 • Fax: 39-0363-35-14-75
Cambrex Bio Ciencia Brasil Ltda.
55-11-5180-3677 • Fax: 55-11-5180-3648
Cambrex Chemicals Pvt. Ltd. (India)
91-22-5697-2883/84/85 • Fax: 91-22-5697-2888 [email protected]
Technical Service
Cambrex endotoxin detection expertise is just a phone call away. Our dedicated technical specialists are always ready to answer your endotoxin testing-related questions. For assistance in your lab, our technical sales force is available through a world-wide network. Workshops are conducted throughout this network to supply both the novice and the experienced LAL user with answers to the most difficult challenges. With over 20 years of LAL experience, Cambrex will provide you with the best technical support in the industry. For questions regarding the endotoxin detection assays, please contact our Technical Service Specialists. U.S. and other non-European locations, call (800) 654-4452 or (301) 898-7025 ext. 7822 or e-mail [email protected] Fax: (301) 852-5663 for U.S. and other non-European locations European customers can e-mail [email protected] Or, visit our web site at www.cambrex.com/LAL
Sales & Customer Service
Our customer service department is filled with tenacious problem solvers who are pleased to find the answers to your questions and to assist you with your order.
Cambrex Bio Science Walkersville, Inc.
8830 Biggs Ford Road • Walkersville, MD 21793 (888) 403-8772 or (301) 898-7025 Fax: (301) 845-8708 for domestic orders and (301) 845-8291 for international orders. www.cambrex.com • [email protected]
Kinetic-QCL, QCL-1000, PYROGENT, PyroGene and WinKQCL are registered trademarks of Cambrex Bio Science Walkersville, Inc. ELx808, ELx808R and FLx800 are trademarks of Bio-Tek. BioPur is a registered trademark of Eppendorf International, Inc. © 2004, Cambrex, Inc.
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Gel Clot Assays
PYROGENT® Gel Clot LAL
The PYROGENT Gel Clot Assay is a qualitative LAL test for Gram-negative bacterial endotoxin. PYROGENT is available as a lysate kit with sensitivities of 0.03, 0.06, 0.125 and 0.25 EU/mL. Standard kit sizes include 250 and 80 tests, and a 25-test kit in a single test vial format is available. These kits do not include a matched control standard endotoxin. However, the standard can be purchased separately (see Gel Clot Accessory Products, page 8). A Certificate of Quality is included with each kit. STORAGE CONDITIONS • 2°C – 8°C.
PYROGENT
Cat. No. F209 Size 50 tests Sensitivity EU/mL 0.06, 0.125, 0.25
Contains: 1 x 50 tests/vial of lysate
Complete 20 Test Kit
Cat. No. 50-500U-06 50-500U-12 Size 20 tests 20 tests Sensitivity EU/mL 0.06 0.125
ORDERING INFORMATION
PYROGENT
Cat. No. N104 N183-06 N184-06 N183-125 N184-125 N183-25 N184-25 Size 250 tests 80 tests* 250 tests** 80 tests 250 tests 80 tests 250 tests Sensitivity EU/mL 0.03 0.06 0.06
Contains: 22 single test vials 5 inhibition control vials 1 positive control vial 1 x 5 mL vial LAL reagent water 28 pipettes 1 sheet of labels
Limulus Amebocyte Lysate Control Kit
Cat. No. 50-510U Size 5 tests
0.125 0.125 0.25 0.25 Contains: 5 positive control vials 5 negative control vials
Inhibition Control
Cat. No. 50-506U Size 5 single test vials
*80 tests = Contains: 5 x 16 tests/vial of lysate **250 tests = Contains: 5 x 50 tests/vial of lysate
PYROGENT (Single Test Vials)
Cat. No. N189-03 N189-06 N189-125 N189-25 Size 25 tests 25 tests 25 tests 25 tests Sensitivity EU/mL 0.03 0.06 0.125 0.25
Contains: 25 single test vials of lysate
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Gel Clot Assays
PYROGENT® Plus Gel Clot LAL
The PYROGENT Plus Gel Clot Assay combines PYROGENT LAL with a matched control standard endotoxin. The Certificate of Quality documenting the FDA and USP required RSE/CSE correlation is included in each kit. PYROGENT Plus kits are available with sensitivities of 0.03, 0.06, 0.125 and 0.25 EU/mL. Standard kit sizes are 200 and 64 tests. Bulk configurations containing 4,000 tests are also available. STORAGE CONDITIONS • 2°C – 8°C.
PYROGENT Plus Single Test Vials
Cat. No. N289-03 N289-06 N289-125 N289-25 Size 24 tests 24 tests 24 tests 24 tests Sensitivity EU/mL 0.03 0.06 0.125 0.25
Contains: 1 x 1 mL vial endotoxin 24 single test vials of lysate
ORDERING INFORMATION
PYROGENT Plus
Cat. No. N204 N283-06 N284-06 N283-125 N284-125 N283-25 N284-25 Size 200 tests 64 tests 200 tests 64 tests 200 tests 64 tests 200 tests Sensitivity EU/mL 0.03 0.06 0.06 0.125 0.125 0.25 0.25
Contains: 1 x 10 ng/vial endotoxin 64 Tests = Contains: 4 x 16 tests/vial of lysate 200 Tests = Contains: 4 x 50 tests/vial of lysate
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Gel Clot Assays
Gel Clot Bulk Configurations
Bulk configurations are available for those laboratories using large volumes of reagents. These configurations are made to order, and production lead times are required. Please inquire for more information:
ORDERING INFORMATION
PYROGENT® Plus Bulk Kit
Cat. No. N488 N288-06 N288-125 N288-25 Size 4,000 tests 4,000 tests 4,000 tests 4,000 tests Sensitivity EU/mL 0.03 0.06 0.125 0.25
Contains: 20 x 10 ng/vial endotoxin 80 x 50 tests/vial of lysate
Bulk Lysate
Cat. No. E203L E203U E209L E209U F245U Size 25 x 50 test/vial 100 x 50 test/vial 25 x 50 test/vial 100 x 50 test/vial 100 x 16 test/vial Sensitivity EU/mL 0.03 0.03 0.06, 0.125, 0.25 0.06, 0.125, 0.25 0.06, 0.125, 0.25
Bulk Endotoxin
Cat. No. 7360L Size 25 vials, 10 ng/vial
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Gel Clot Assays
PYROGENT® Ultra Gel Clot LAL
The PYROGENT Ultra Gel Clot Assay contains a series of convenient pre-mixed liquid endotoxin standards at the concentrations necessary to create a standard curve. Designed to increase your productivity in the lab, these liquid endotoxin standards decrease time, hassle and potential human error by eliminating the need for dilution and vortexing. A Certificate of Quality is included with each kit. STORAGE CONDITIONS • 2°C – 8°C.
ORDERING INFORMATION
Gel Clot Accessory Products
Cambrex’s Control Standard Endotoxin is referenced against the USP Reference Standard Endotoxin following the procedures set forth in the Guidelines on Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices. Certificates of Quality showing potency are available upon request. STORAGE CONDITIONS • 2°C – 8°C.
PYROGENT Ultra
Cat. No. N403 N406 N412 Size 200 tests 200 tests 200 tests Sensitivity EU/mL 0.03 0.06 0.125
Contains: 5 x 5 mL gel clot liquid endotoxin standards (2 λ, λ, 0.5 λ, 0.25 λ, 20 λ) 4 x 50 tests/vial of lysate
ORDERING INFORMATION
Endotoxin (E. coli)
Strain O55:B5 Cat. No. N185 N186 Size 5 vials x 2.5 mg/vial 5 vials x 10 ng/vial
Endotoxin Challenge Vials
Cat. No. N187 Size 25 vials
Used for oven validations E. coli endotoxin (>1,000 EU/vial)
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Kinetic Assays
PYROGENT®-5000 Turbidimetric LAL
PYROGENT-5000 is a quantitative, kinetic assay for the detection of Gram-negative bacterial endotoxin. This assay has a sensitivity range from 100 EU/mL to 0.01 EU/mL and is ideal for testing water samples, large volume parenterals, and medical devices. The PYROGENT-5000 assay is performed in a 96-well plate allowing for high-throughput processing. The use of an incubating plate reader is required for this assay to measure change in turbidity (see Instrumentation and Software, page 13). The sample reaction times are then plotted against a standard curve to calculate endotoxin concentration. A Certificate of Quality is included in each kit. STORAGE CONDITIONS • 2°C – 8°C. N688
PYROGENT®-5000 Bulk Configurations
Bulk Configurations are available for those laboratories using large volumes of reagents. These configurations are made to order, and production lead times are required. Please inquire for more information.
ORDERING INFORMATION
Cat. No. N588 Description Sensitivity (EU/mL)
2,250 tests 0.01 – 100 Contains: 45 x 50 tests/vial lysate 45 vials reconstitution buffer 10 x 50 ng/vial endotoxin 4,500 tests 0.01 – 100 Contains: 45 x100 tests/vial lysate 45 vials reconstitution buffer 10 x 50 ng/vial endotoxin
ORDERING INFORMATION
PYROGENT-5000 Turbidimetric LAL
Cat. No. N383 N384 Size Sensitivity (EU/mL) 0.01 – 100 0.01 – 100 100 tests (2 x 50 tests/vial lysate) 200 tests (2 x 100 tests/vial lysate)
Contains: Lysate 2 vials reconstitution buffer 1 x 50 ng/vial endotoxin
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Kinetic Assays
Kinetic-QCL® Chromogenic LAL
Kinetic-QCL is a quantitative, kinetic assay for the detection of Gram-negative bacterial endotoxin. It is the most sensitive of the LAL assays, having a sensitivity range from 50 EU/mL to 0.005 EU/mL. Kinetic-QCL is ideal for testing small volume parenterals, vaccines, antibiotics, and biologicals. This assay is performed in a 96-well plate allowing for high-throughput processing. The sample reaction times are then plotted against a standard curve to calculate endotoxin concentration. An incubating plate reader is required for this assay (see Instrumentation and Software, page 13). A Certificate of Quality is included in each kit. STORAGE CONDITIONS • 2°C – 8°C.
Kinetic-QCL Bulk Configurations
Bulk Configurations are available for those laboratories using large volumes of reagents. These configurations are made to order, and production lead times are required.
ORDERING INFORMATION
Please inquire for pricing and more information. Cat. No. K50-643L Description Sensitivity (EU/mL)
600 tests 0.005 – 50 Contains: 25 x 24 tests/vial lysate 2,400 tests 0.005 – 50 Contains: 100 x 24 tests/vial lysate
K50-643U
ORDERING INFORMATION
Kinetic-QCL Chromogenic LAL
Cat. No. 50-650U Size 192 tests Sensitivity (EU/mL) 0.005 – 50
Endotoxin
Cat. No. E50-643L Description 25 x 10 ng/vial endotoxin
Contains: 8 x 24 tests/vial of Kinetic-QCL lysate 2 x 10 ng/vial endotoxin 3 x 30 mL vials LAL reagent water
Lysate and Endotoxin
Cat. No. 50-650 NV Description Sensitivity (EU/mL) 2,040 tests 0.005 – 50 Contains: 85 x 24 tests/vial lysate 15 x 10 ng/vial endotoxin 2,400 tests 0.005 – 50 Contains: 100 x 24 tests/vial lysate 10 x 10 ng/vial endotoxin
50-650H
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PyroGene Recombinant Factor C Assay
®
PyroGene Recombinant Factor C Endotoxin Detection System represents another first from the endotoxin detection technology leader. Our scientists have produced a recombinant form of Factor C, the first component in the Limulus clotting cascade activated by endotoxin. Once again, Cambrex leads the way with evolutionary technology that promises to reduce the dependence on animal-based endotoxin assays.
Figure 2: The rFC Assay and LAL Assays Measure Similar Endotoxin Potency in Purified LPS
Advantages of PyroGene:
• Greater endotoxin specificity • Elimination of false positive glucan reactions • Less lot-to-lot variability • No animal utilization
PyroGene represents a reliable, environmentally friendly alternative to LAL. We at Cambrex invite you to experience the PyroGene alternative.
Figure 1: rFC Endotoxin Standard Curves Using 4 Different Lots of rFC
Similar endotoxin potency is detected in purified lipopolysaccharides using PyroGene®, Kinetic-QCL® and PYROGENT®-5000 assays. STORAGE CONDITIONS • 2°C – 8°C.
ORDERING INFORMATION
PyroGene Recombinant Factor C Assay
Cat. No. 50-658U Size 192 tests
NEW
Sensitivity (EU/mL) 0.01 – 10
For the instrumentation and software see page 13.
Recombinant Factor C (rFC) is activated by endotoxin binding, and the active moiety created then acts to cleave a synthetic substrate which results in the generation of a fluorogenic compound. The reaction is run in a 96-well microplate and measured at time zero and after a one-hour incubation in a fluorescent microplate reader using excitation/emission wavelengths of 380/440 nm. The log net fluorescence is proportional to the log endotoxin concentration and is linear in the 0.01 – 10 EU/mL range. Lot-to-lot standard curves exhibit excellent reproducibility.
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Chromogenic End-Point Assays
QCL-1000® Chromogenic End-Point LAL
QCL-1000, the most rapid of the LAL tests, is a 16 minute, quantitative endpoint assay that has a sensitivity range from 1.0 EU/mL to 0.1 EU/mL. This chromogenic assay forms a yellow color and is measured photometrically at 405 – 410 nm. With QCL-1000, a multichannel pipette and a 96-well plate, you can run 96 reaction wells at one time. This assay can also be run in tubes. A Certificate of Quality is included in each kit. STORAGE CONDITIONS • 2°C – 8°C.
ORDERING INFORMATION
QCL-1000 Chromogenic End-Point LAL
Cat. No. 50-647U Size Sensitivity (EU/mL) 120 tests 0.1 – 1.0 Contains: 5 x 1.4 mL lysate 1 x 1 mL vial endotoxin 2 x 30 mL vials LAL Reagent Water 2 x 6.5 mL chromogenic substrate 300 tests 0.1 – 1.0 Contains: 5 x 3 mL lysate 2 x 1 mL vial endotoxin 5 x 6.5 mL chromogenic substrate
QCL-1000® Accessory Products
Endotoxin
Strain 0111:B4 Cat. No. E50-640 Size 1 x 1 mL vial endotoxin Approximately 15 – 40 EU/mL
50-648U
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Instrumentation and Software
Standard Kinetic System
This system comes complete with all of the hardware and software needed to run the kinetic quantitative LAL assays. Cat. No. 25-335 Includes: Dell computer with Pentium IV Microprocessor Software: Windows 2000®, WinKQCL® software Flat Panel 15.0 inch viewable monitor HP laserjet® 1300 (or equivalent) Bio-Tek® ELx808™ incubating 96-well plate reader Stepped neutral density plate
® ™
FLx800™ Fluorescent Microplate Reader with Ex/Em 380/440
Cat. No. 25-344 UV-Vis filter fluorometer for reading and incubation of 96-well microplates. Works with WinKQCL® Software V 3.00.
NEW
High Throughput System
Robotic workstations to completely automate LAL testing are available and can be tailored to your needs.
PyroTherm Pyrogen Monitoring System
NEW
Bio-Tek ELx808 Incubating Reader
Cat. No. 25-315 UV-Vis filter spectrophotometer for reading and incubation of 96-well microplates. Works with WinKQCL Software.
PyroTherm is a computer integrated, high performance, programmable heat block. This equipment is designed for a broad range of temperatures, from 5°C – 300°C, but has been optimized for the LAL gel clot test. PyroGel software is a 21 CFR Part 11 compliant software package designed to work with the PyroTherm unit. The software offers temperature profiling during an assay, as well as integrated sample management with sample tracking and automatic calculation and reporting. In addition, depyrogenation of test tubes can be done using the heat block. Cat. No. 25-347
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Instrumentation and Software
WinKQCL® Software V 2.00
WinKQCL is the industry leading software application designed to manage, analyze, and report kinetic LAL assay data. It features compliance with 21 CFR Part 11 for electronic records and signatures, provides efficiency with a trending database, validation support, and bar code reading. Cat. No. 25-301
WinKQCL® Software V 3.00
NEW
Our newest version of WinKQCL continues to be compliant with 21 CFR Part 11 regulations. We have built in the ability to share databases over a network in a client/server interface. Test results can now be exported to a LIMS database. The software will also support our new PyroGene® assay and will interface with the FLx800™ Reader.
Client/Server Version IQ/OQ/PQ Manual for V 2.00
Installation, operational, and performance qualification manual for documented installation of the system. Cat. No. 25-338M Cat. No. 25-348
Additional Software License
(required for multiple workstations) Cat. No. 25-353
Validation Manual for V 2.00
This notebook features over 500 documented test cases used to validate the software. Cat. No. 25-341
IQ/OQ/PQ Manual for Kinetic LAL System WinKQCL V 3.00
Cat. No. 25-349
System Qualification Service
A trained specialist from Cambrex performs the installation, operation, and performance qualification of the Kinetic System. Cat. No. 25-339S
Validation Manual for WinKQCL V 3.00
Cat. No. 25-350
IQ/OQ/PQ Manual for PyroGene®
Cat. No. 25-354
Assay Plate
Template Manager
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Accessory Products
LAL Accessory Products
Reagents
Name ß-G-Blocker Pyrosperse MgCl2 Tris Buffer LAL Reagent Water Cat. No. N190 N188 S50-641 S50-642 W50-640 W50-100 W50-500 Size 5 x 5 mL vials 5 x 5 mL vials 30 mL vial 30 mL vial 30 mL 100 mL 500 mL Storage Conditions 2°C – 8°C 2°C – 30°C 2°C – 30°C 2°C – 30°C 2°C – 8°C 15°C – 30°C 15°C – 30°C Comments Used to block glucan interference Dispersing agent 10 mM Solution 50 mM Solution <0.005 EU/mL
Labware
Name Pyrogen-free Test Tubes Pyrogen-free Test Tubes Pyrogen-free Dilution Tubes Reagent Reservoir Sample Container, Depyrogenated Cat. No. N201 N205 N207 25-268 80-507 80-507L 80-507U 25-415 25-416 25-417 25-342 25-038 10 mL Size 10 x 75 mm 10 x 75 mm 13 x 100 mm Quantity 50/pkg 50/pkg 30/pkg 10/pkg Each 25/box 100/box 5 trays/pkg; 96 tips/tray Comments W/polypropylene screw caps Foil wrapped without caps Foil wrapped without caps For use with 8-channel pipettes Glass bottles with screw caps
NEW Eppendorf BioPur®
Pipette Tips Stepped Neutral Density Plate Ground Aluminum Block with Lid
200 µL 300 µL 1,000 µL
Only for multichannel pipettors
NEW
For use in ELx808™, ELx808R™, and Kinetic-QCL® plate readers. Calibrated against NIST traceable standards. Each 50/case Holds a 96-well plate in a dry bath multiblock heater 96-well, <0.0005 EU/well
LAL Reagent Grade Plates 25-340
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Testing Services
Endotoxin Detection Testing Service Information
Our Testing Service offers you the best in routine and customized endotoxin testing. Our facility is GMP compliant and provides expertise in gel clot, kinetic chromogenic and kinetic turbidimetric assays. All testing is performed in accordance with FDA Guidelines. Whether you are from a university research laboratory or a QC lab in a major pharmaceutical company, Cambrex has the capabilities you need for reliable, accurate and confidential results. Please contact the LAL Testing Service to obtain general information and the LAL Information Sheet: Request for In-House Product Testing.
U.S. Testing Service Customers:
(800) 654-4452 • (301) 898-7025 ext. 7820 Fax: (301) 845-4153 e-mail: [email protected]
European Testing Service Customers:
Phone: +32-87-32-16-11 Fax: +32-87-35-19-67 e-mail: [email protected] [email protected]
Sample Shipment:
Cambrex Bio Science Walkersville, Inc. LAL Testing Service (B-06) Central Receiving 8830 Biggs Ford Road Walkersville, MD 21793-0127
Sample Shipment:
Cambrex Bio Science, Verviers Parc Industriel de Petit Rechain B-4800 Verviers Belgium
Testing Services
Type of Test Preliminary Screening of New Product Product Validation Per FDA Guidelines U.S. Cat. No. 80-500 80-501 80-502 Sample Testing Endotoxin Determination Routine Testing FDA End Product Release SOP Writing ß-D-Glucan Testing Custom Depyrogenation Container Depyrogenation Endotoxin Testing w/Recombinant Factor C 80-503 80-509 80-504 80-510 80-512 80-514 — — — Europe Cat. No. 80-500 80-501 80-502 80-503 80-509 80-504 80-510 — 80-511 80-515 80-516 80-517 Endotoxin Challenge Vials w/ Positive Product Controls Endotoxin Testing w/Positive Product Controls Screening Assay w/PyroGene Inhibition/Enhancement Assay Single lot of product 3 lots of product with all lots submitted at one time 1 lot, single sample Each additional lot, single sample 1 lot, 3 samples Each additional lot, 3 samples Description
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Testing Services
Pre-Paid Test Services for Europe
Cambrex European LAL Testing Service offers a mail-in pre-paid testing service for users not requiring testing according to the pharmaceutical or USP medical device regulations. Pre-paid rapid-endo test packs can be ordered as you would any other product. You will be sent a pre-addressed padded envelope, sample bottles and instructions. Samples can be mailed whenever you have a requirement for an endotoxin test. Samples received using this service are tested at the pre-set dilutions indicated below.
European Testing Service Customers:
Phone: +32-87-32-16-11 Fax: +32-87-35-19-67 e-mail: [email protected] [email protected]
Sample Shipment:
Cambrex Bio Science, Verviers Parc Industriel de Petit Rechain B-4800 Verviers Belgium
European Testing Services
Type of Test Rapid-Endotest single water sample Rapid-Endotest single dialysis fluid sample Rapid-Endotest single research sample Rapid-Endotest for up to five water samples Rapid-Endotest for up to five dialysis fluid samples Rapid-Endotest for up to five research samples Cat. No. 91-101 91-102 91-103 95-101 95-102 95-103 Description Tested neat with positive product control Tested at 1:5 and 1:10 dilutions with positive product controls Tested at 1:10, 1:100 and 1:1000 dilutions with positive product controls Tested neat with positive product controls Tested at 1:5 and 1:10 dilutions with positive product controls Tested at 1:10, 1:100 and 1:1000 dilutions with positive product controls
Sample Type Water Dialysis Fluids Research Samples
Dilutions None (Neat) 1:5, 1:10 1:10, 1:100, 1:1000
Result Range (EU) 0.005 – 50 0.025 – 500 0.05 – 50,000
Result Range (pg) 0.5 – 5,000 2.5 – 50,000 5.0 – 5,000,000
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